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Di Santo A, Tarchi L, Villa G, Castellini G, Ricca V, Squecco R, Papini AM, Real‐Fernandez F, Rovero P. GDF15 Analogues Acting as GFRAL Ligands. ChemMedChem 2025; 20:e202400961. [PMID: 39907315 PMCID: PMC12058240 DOI: 10.1002/cmdc.202400961] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2024] [Revised: 01/22/2025] [Accepted: 02/04/2025] [Indexed: 02/06/2025]
Abstract
Growth differentiation factor 15 (GDF15) is a TGF-β superfamily member involved in diverse physiological and pathological processes. It is expressed in various tissues and its circulating levels rise during exercise, aging, pregnancy, and conditions such as cancer, cardiovascular disease, and infections. The biological activities of GDF15, including anorexia and cachexia, are primarily mediated through the GFRAL receptor, localized in the brainstem and functioning via RET co-receptor recruitment. This signaling is crucial for energy homeostasis and nausea induction. Recent studies suggest a broader GFRAL distribution, potentially explaining GDF15's distinct roles. These findings sparked interest in leveraging GDF15-GFRAL pathways for therapeutic development. Two primary strategies include GDF15 analogues as GFRAL agonists for obesity treatment and GDF15-derived peptides as antagonists to counteract cancer-induced cachexia and related disorders. This review highlights advancements in understanding GDF15-GFRAL signaling and its implications, summarizing bioactive GDF15-derived molecules, their pharmacological applications, and offering insights into novel treatment avenues for GDF15-associated conditions.
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Affiliation(s)
- Andrea Di Santo
- Department of NeurosciencePsychologyPharmacology and Infant HealthInterdepartmental Research Unit of Peptide and Protein Chemistry and BiologyUniversity ofFlorenceVia Ugo Schiff, 6, Sesto FiorentinoFI, 50019Italy
| | - Livio Tarchi
- Department of Health SciencePsychiatry UnitUniversity of Florence, Largo Brambilla 3FlorenceFI, 50134Italy
| | - Gianluca Villa
- Department of Health ScienceAnesthesiology UnitUniversity of Florence, Largo Brambilla 3FlorenceFI, 50134Italy
| | - Giovanni Castellini
- Department of Health SciencePsychiatry UnitUniversity of Florence, Largo Brambilla 3FlorenceFI, 50134Italy
| | - Valdo Ricca
- Department of Health SciencePsychiatry UnitUniversity of Florence, Largo Brambilla 3FlorenceFI, 50134Italy
| | - Roberta Squecco
- Department of Experimental and Clinical MedicineSection of Physiological SciencesUniversity of Florence, Viale Morgagni 63FlorenceFI, 50134Italy
| | - Anna Maria Papini
- Department of Chemistry “Ugo Schiff”Interdepartmental ResearchUnit of Peptide and Protein Chemistry and BiologyUniversity ofFlorencevia della Lastruccia, 3–13, Sesto FiorentinoFI, 50019Italy
| | - Feliciana Real‐Fernandez
- Institute of Chemistry of Organometallic Compounds –National, Research Council of Italy (ICCOM-CNR)Via Madonna del Piano, 10, Sesto FiorentinoFI, 50019FlorenceItaly
| | - Paolo Rovero
- Department of NeurosciencePsychologyPharmacology and Infant HealthInterdepartmental Research Unit of Peptide and Protein Chemistry and BiologyUniversity ofFlorenceVia Ugo Schiff, 6, Sesto FiorentinoFI, 50019Italy
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Xu J, Li H, Sze DMY, Chan VWS, Yang AWH. Effectiveness of qigong and Tai Chi for quality of life in patients with cancer: an umbrella review and meta-analysis. BMC Complement Med Ther 2025; 25:141. [PMID: 40240905 PMCID: PMC12004731 DOI: 10.1186/s12906-025-04875-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2024] [Accepted: 03/31/2025] [Indexed: 04/18/2025] Open
Abstract
BACKGROUND Qigong and Tai Chi (QTC) have been adopted by cancer patients as the complementary treatment to their conventional care. This umbrella review aimed to evaluate the clinical effectiveness of QTC in cancer patients' quality of life (QoL) and its safety. METHODS Twenty-five databases were searched from their respective inception to March 2025. Systematic reviews (SRs) and meta-analyses of randomized controlled trials (RCTs) assessing cancer patients' QoL after practicing QTC were included. The search strategy included Qigong, Tai Chi, quality of life, cancer, systematic review, and meta analysis. The extracted data was analyzed using standardized mean difference, mean difference, or odds ratio with 95% confidence intervals. RESULTS Nine SRs were included in the qualitative analysis, and six of the SRs were included for the meta-analyses. Results showed that QTC may improve cancer patients' overall QoL, physiological scores (physical functioning, fatigue, and sleep quality), psychological scores (mental health and anxiety), and immunity, compared to the control groups. However, meta-analyses did not demonstrate significant differences in subgroup analyses of depression, although it showed that QTC may reduce depression in cancer patients. No serious adverse events of QTC were reported. CONCLUSION QTC can be considered a safe intervention method for improving QoL in patients with cancer. Due to substantial heterogeneity, more rigorously-designed RCTs on QTC for cancer patients should be conducted, focusing on standardizing QTC practices and QoL instruments to assess QTC effects. PROSPERO REGISTRATION NUMBER CRD42021253216.
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Affiliation(s)
- Jing Xu
- School of Health and Biomedical Sciences, STEM College, RMIT University, Bundoora, VIC, 3083, Australia
| | - Hong Li
- School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, 510515, Guangdong, China
- School of Science, STEM College, RMIT University, Melbourne, VIC, 3000, Australia
| | - Daniel Man-Yuen Sze
- School of Health and Biomedical Sciences, STEM College, RMIT University, Bundoora, VIC, 3083, Australia
| | - Vincent Wan Shing Chan
- School of Health and Biomedical Sciences, STEM College, RMIT University, Bundoora, VIC, 3083, Australia
| | - Angela Wei Hong Yang
- School of Health and Biomedical Sciences, STEM College, RMIT University, Bundoora, VIC, 3083, Australia.
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Albanell-Fernández M, Rodríguez Mues MC, Figueras C, Altamirano M, Monge-Escartín I, Riu-Viladoms G, Carcelero San Martín E, Corominas Bosch ML, Gaba García L. Evaluation of chemotherapy-induced nausea and vomiting in low, moderate, and highly emetogenic schemes between sexes. Support Care Cancer 2025; 33:261. [PMID: 40064679 PMCID: PMC11893662 DOI: 10.1007/s00520-025-09319-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2024] [Accepted: 02/28/2025] [Indexed: 03/14/2025]
Abstract
PURPOSE Sex influences chemotherapy-induced nausea and vomiting (CINV). However, in clinical practice, males and females receive the same antiemetic prophylaxis. We compared CINV between sexes in patients with different emetic risk schemes and evaluated the predisposing factors and main adverse effects caused by antiemetics. METHODS Prospective observational study conducted in a tertiary-care hospital from February 2023 to May 2024 in patients starting chemotherapy or a new treatment line. CINV was evaluated using MASCC antiemetic tool, in acute (< 24 h) and delayed phases (24-120 h). Results were analyzed using χ2 test or Fisher's exact test. The primary endpoint was complete response (CR) rate, defined as no CINV and no use of rescue medication. Univariate and multivariate logistic regressions were used to identify patient-related risk factors associated with non-CR. RESULTS A total of 176 completed questionnaires (CQ): 94 for males and 82 for females were collected. The proportion of males who remained emesis-free was superior to females in the acute phase (100% versus 92.7%, p = 0.009). Likewise, a higher proportion of males remained nausea-free in the acute (91.5% versus 79.3%, p = 0.021) and delayed phase (90.4% versus 79.3%, p = 0.037). In females, young age (< 60 years) and previous nausea and vomiting during pregnancy may contribute to non-CR. A high proportion of patients reported adverse events like constipation and insomnia. Females suffered more constipation than males (52.4% versus 37.2%, p = 0.043). CONCLUSION Females experienced more CINV than males, with the consequences that entail. Antiemetic prophylaxis should be personalized, considering sex and age and not only the chemotherapy emetic potential.
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Affiliation(s)
- Marta Albanell-Fernández
- Pharmacy Department, Division of Medicines, Hospital Clinic of Barcelona, Barcelona, Spain.
- Department of Physiological Science, School of Medicine, Universitat de Barcelona (UB), L'Hospitalet de Llobregat, Barcelona, Spain.
| | | | - Carolina Figueras
- Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Mariana Altamirano
- Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Inés Monge-Escartín
- Pharmacy Department, Division of Medicines, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Gisela Riu-Viladoms
- Pharmacy Department, Division of Medicines, Hospital Clinic of Barcelona, Barcelona, Spain
| | | | | | - Lydia Gaba García
- Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain
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Borner T, Pataro AM, De Jonghe BC. Central mechanisms of emesis: A role for GDF15. Neurogastroenterol Motil 2025; 37:e14886. [PMID: 39108013 PMCID: PMC11866100 DOI: 10.1111/nmo.14886] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2024] [Revised: 07/08/2024] [Accepted: 07/24/2024] [Indexed: 02/06/2025]
Abstract
BACKGROUND Nausea and emesis are ubiquitously reported medical conditions and often present as treatment side effects along with polymorbidities contributing to detrimental life-threatening outcomes, such as poor nutrition, lower quality of life, and unfavorable patient prognosis. Growth differentiation factor 15 (GDF15) is a stress response cytokine secreted by a wide variety of cell types in response to a broad range of stressors. Circulating GDF15 levels are elevated in a range of medical conditions characterized by cachexia and malaise. In recent years, GDF15 has gained scientific and translational prominence with the discovery that its receptor, GDNF family receptor α-like (GFRAL), is expressed exclusively in the hindbrain. GFRAL activation may results in profound anorexia and body weight loss, effects which have attracted interest for the pharmacological treatment of obesity. PURPOSE This review highlights compelling emerging evidence indicating that GDF15 causes anorexia through the induction of nausea, emesis, and food aversions, which encourage a perspective on GDF15 system function in physiology and behavior beyond homeostatic energy regulation contexts. This highlights the potential role of GDF15 in the central mediation of nausea and emesis following a variety of physiological, and pathophysiological conditions such as chemotherapy-induced emesis, hyperemesis gravidarum, and cyclic vomiting syndrome.
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Affiliation(s)
- Tito Borner
- Department of Biobehavioral Health Sciences, School of NursingUniversity of PennsylvaniaPhiladelphiaPennsylvaniaUSA
- Department of PsychiatryUniversity of Pennsylvania, Perelman School of MedicinePhiladelphiaPennsylvaniaUSA
- Department of Biological Sciences, Human and Evolutionary Biology SectionUniversity of Southern CaliforniaLos AngelesCaliforniaUSA
| | - Allison M. Pataro
- Department of Biobehavioral Health Sciences, School of NursingUniversity of PennsylvaniaPhiladelphiaPennsylvaniaUSA
| | - Bart C. De Jonghe
- Department of Biobehavioral Health Sciences, School of NursingUniversity of PennsylvaniaPhiladelphiaPennsylvaniaUSA
- Department of PsychiatryUniversity of Pennsylvania, Perelman School of MedicinePhiladelphiaPennsylvaniaUSA
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Ramasubbu MK, Hota D, Das Majumdar SK, Parida DK, Mukherjee P, Srinivasan A. A group sequential response-adaptive randomized double-blinded clinical trial to evaluate the safety and efficacy of add-on olanzapine plus pregabalin for the prevention of chemotherapy-induced nausea and vomiting. Support Care Cancer 2025; 33:203. [PMID: 39969577 DOI: 10.1007/s00520-025-09275-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2023] [Accepted: 02/13/2025] [Indexed: 02/20/2025]
Abstract
PURPOSE Even with antiemetic prophylaxis, patients undergoing cancer chemotherapy often still experience chemotherapy-induced nausea and vomiting (CINV). Neurokinin-1 (NK-1) receptor antagonists will prevent CINV effectively but are not affordable for patients of low socioeconomic status. METHODS In this group sequential, response adaptive randomized double-blinded clinical trial, patients of low socioeconomic who cannot afford NK-1 receptor antagonists, planned for highly emetogenic chemotherapy (HEC) agents received olanzapine 5 mg plus pregabalin 75 mg or placebo orally for five days add-on to standard antiemetic therapy (injection ondansetron 8 mg + injection dexamethasone 12 mg on day one followed by oral dexamethasone 8 mg on days 2 to 4). The primary outcome was the difference in the proportion of patients with "overall no nausea" between groups. Following the interim analysis, the allocation ratio was modified, resulting in more patients being assigned to the well-performing arm. RESULTS Initially, 30 patients were equally randomized into two groups. As the experimental group performed well in the interim analysis, the allocation ratio was changed to 2:1 for the subsequent period. Finally, the experimental group (n = 36) performed better in terms of "overall no nausea" than the control group(n = 18) (41.6% vs. 5.5%, p = 0.008). Sedation and dizziness were significantly greater in the experimental group compared to the standard-of-care group. CONCLUSION Olanzapine 5 mg plus pregabalin 75 mg add-on to a combination of dexamethasone and ondansetron will significantly prevent the incidence of CINV compared to a combination of dexamethasone and ondansetron alone. However, the combination is associated with sedation and dizziness as adverse events. TRIAL REGISTRATION Clinical trial registry-India (CTRI/2021/08/035451). Registration Date: 05/08/2021.
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Affiliation(s)
- Mathan Kumar Ramasubbu
- Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India
| | - Debasish Hota
- Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India
| | - Saroj Kumar Das Majumdar
- Department of Radiation Oncology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India
| | - Dillip Kumar Parida
- Department of Radiation Oncology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India
| | - Priyanka Mukherjee
- Department of Radiation Oncology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India
| | - Anand Srinivasan
- Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
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Chow R, Basu A, Kaur J, Hui D, Im J, Prsic E, Boldt G, Lock M, Eng L, Ng TL, Zimmermann C, Scotte F. Efficacy of cannabinoids for the prophylaxis of chemotherapy-induced nausea and vomiting-a systematic review and meta-analysis. Support Care Cancer 2025; 33:193. [PMID: 39953210 PMCID: PMC11828838 DOI: 10.1007/s00520-025-09251-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2024] [Accepted: 02/06/2025] [Indexed: 02/17/2025]
Abstract
BACKGROUND Cannabinoids have potential efficacy as prophylaxis for chemotherapy-induced nausea and vomiting (CINV), but no recent meta-analysis has reported on their relative efficacy compared to other antiemetics. The aim of this meta-analysis is to examine the relative efficacy of cannabinoids for prophylaxis of CINV. METHODS A literature search was conducted in OVID Medline, EMBASE, and Cochrane Central Register of Controlled Trials from inception up until March 2024. Articles were included if they reported on complete response, no nausea, no vomiting or no use of rescue medications, and were randomized controlled trials with cannabinoids in one arm. Meta-analysis was conducted for each endpoint and for a composite endpoint amalgamating existing endpoints. Subgroup analyses by medication used in control arm and by study design were conducted. Cumulative and leave-one-out analysis was also conducted. Type I error was set at 0.05. RESULTS A total of 26 studies were included in this meta-analysis, of which 23 were published before the 2000s. Nearly half of the included studies had some concern for bias. Cannabinoid had superior overall CINV control compared to placebo (RR 2.65, 95% CI 1.70-4.12, I2 = 0.00%). However, there was no difference between cannabinoid and active treatment alternatives (most using dated single-agent regimens) for any outcomes. A recent phase II/III trial demonstrated superior efficacy of THC:CBD for secondary prevention of CINV when used as adjunctive therapy alongside modern antiemetic regimens, albeit mostly without olanzapine. CONCLUSIONS There is scant evidence for efficacy of cannabinoids for CINV in the era of triple and quadruple antiemetics. Although THC:CBD showed promised in a recent trial, further trials should examine its safety and efficacy in the context of regimens containing olanzapine.
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Affiliation(s)
- Ronald Chow
- Princess Margaret Cancer Centre, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
- Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
- Verspeeten Family Cancer Centre, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.
| | - Anna Basu
- Verspeeten Family Cancer Centre, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - Jagdeep Kaur
- Verspeeten Family Cancer Centre, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - David Hui
- The University of Texas MD Anderson Cancer Center, Houston, TX, USA
| | - James Im
- Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada
| | - Elizabeth Prsic
- Yale School of Medicine, Yale University, New Haven, CT, USA
| | - Gabriel Boldt
- Verspeeten Family Cancer Centre, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - Michael Lock
- Verspeeten Family Cancer Centre, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - Lawson Eng
- Princess Margaret Cancer Centre, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | - Terry L Ng
- Faculty of Medicine, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada
| | - Camilla Zimmermann
- Princess Margaret Cancer Centre, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | - Florian Scotte
- Gustave Roussy, Université Paris-Saclay Faculté de Médecine, Université Paris-Saclay, Paris, France
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Fairman CM. A practical framework for the design of resistance exercise interventions in oncology research settings-a narrative review. Front Sports Act Living 2024; 6:1418640. [PMID: 39703544 PMCID: PMC11655215 DOI: 10.3389/fspor.2024.1418640] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/16/2024] [Accepted: 11/15/2024] [Indexed: 12/21/2024] Open
Abstract
Resistance exercise (RE) has been demonstrated to result in a myriad of benefits for individuals treated for cancer, including improvements in muscle mass, strength, physical function, and quality of life. Though this has resulted in the development of recommendations for RE in cancer management from various international governing bodies, there is also increasing recognition of the need to improve the design of RE interventions in oncology. The design and execution of RE trials are notoriously complex, attempting to account for numerous cancer/treatment related symptoms/side effects. Further, the design of exercise trials in oncology also present numerous logistical challenges, particularly those that are scaled for effectiveness, where multi-site trials with numerous exercise facilities are almost a necessity. As such, this review paper highlights these considerations, and takes evidence from relevant areas (RE trials/recommendations in oncology, older adults, and other clinical populations), and provide a practical framework for consideration in the design and delivery of RE trials. Ultimately, the purpose of this framework is to provide suggestions for researchers on how to design/conduct RE trials for individuals with cancer, rather than synthesizing evidence for guidelines/recommendations on the optimal RE dose/program.
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Affiliation(s)
- Ciaran M. Fairman
- Exercise Oncology Lab, Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States
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Grosu-Bularda A, Lita FF, Hodea FV, Bordeanu-Diaconescu EM, Cretu A, Dumitru CS, Cacior S, Marinescu BM, Lascar I, Hariga CS. Navigating the Complexities of Radiation Injuries: Therapeutic Principles and Reconstructive Strategies. J Pers Med 2024; 14:1100. [PMID: 39590592 PMCID: PMC11595796 DOI: 10.3390/jpm14111100] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Revised: 10/21/2024] [Accepted: 11/08/2024] [Indexed: 11/28/2024] Open
Abstract
Radiation injuries, particularly those resulting from therapeutic or accidental exposure, present complex challenges for medical management. These injuries can manifest localized skin damage or extend to deeper tissues, presenting as various clinical entities that require treatment strategies, ranging from conservative management to complex surgical interventions. Radiation treatment constitutes a fundamental component of neoplastic management, with nearly two out of three oncological instances undergoing it as an element of their therapeutic strategy. The therapeutic approach to radiation injury consists of expanding prophylactic measures while maintaining the efficacy of treatment, such as conservative treatment or local debridement followed by reconstruction. The armamentarium of reconstructive methods available for plastic surgeons, from secondary healing to free tissue transfer, can be successfully applied to radiation injuries. However, the unique pathophysiological changes induced by radiation necessitate a careful and specialized approach for their application, considering the altered tissue characteristics and healing dynamics. The therapeutic strategy is guided by both the severity and progression of the injury, with the primary aim of restoring functionality and aesthetic aspects while simultaneously minimizing the risk of complications. This paper explores the various conditions encompassed by the term "radiation injury," reviews both non-surgical and surgical therapeutic strategies for managing these injuries, and highlights the unique challenges associated with treating irradiated tissues within specific oncological contexts.
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Affiliation(s)
- Andreea Grosu-Bularda
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Flavia-Francesca Lita
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
- Clinical Department Plastic Surgery and Reconstructive Microsurgery, Central Military Emergency University Hospital “Dr. Carol Davila”, 010825 Bucharest, Romania
| | - Florin-Vlad Hodea
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Eliza-Maria Bordeanu-Diaconescu
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Andrei Cretu
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Catalina-Stefania Dumitru
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Stefan Cacior
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Bogdan-Mihai Marinescu
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinical Department Plastic Surgery and Reconstructive Microsurgery, Central Military Emergency University Hospital “Dr. Carol Davila”, 010825 Bucharest, Romania
| | - Ioan Lascar
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
| | - Cristian-Sorin Hariga
- Department 11, Discipline Plastic and Reconstructive Surgery, University of Medicine and Pharmacy Carol Davila, 050474 Bucharest, Romania; (A.G.-B.); (I.L.); (C.-S.H.)
- Clinic of Plastic Surgery and Reconstructive Microsurgery, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania
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Báez-Gutiérrez N, Suárez-Casillas P, Pérez-Moreno MA, Blázquez-Goñi C, Abdelkader-Martín L. Antiemetic prophylaxis regimens in haematologic malignancies patients undergoing a hematopoietic stem cell transplantation. Which is the best standard of care? A systematic review. Eur J Haematol 2024; 113:564-575. [PMID: 39074908 DOI: 10.1111/ejh.14282] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2024] [Revised: 07/03/2024] [Accepted: 07/11/2024] [Indexed: 07/31/2024]
Abstract
INTRODUCTION This systematic review, adhering to PRISMA guidelines, aimed to evaluate the efficacy and safety of antiemetic prophylaxis in haematological patients undergoing high-dose chemotherapy as part of their hematopoietic stem cell transplantation (HSCT) conditioning regimens. METHODS We performed a comprehensive search in PubMed, EMBASE, ClinicalTrials.gov and the Cochrane database to identify randomised controlled trials (RCTs) and systematic reviews of antiemetic prophylaxis. Studies in English, French, Italian or Spanish were included. This review is registered with PROSPERO, ID CRD42023406380. RESULTS Eight RCTs were analysed. The antiemetic regimens evaluated ranged from monotherapy with 5-Hydroxytryptamine Receptor 3 antagonists (5-HT3RAs) to complex combinations including olanzapine, neurokinin-1 receptor antagonists, 5-HT3RAs and corticosteroids. Complete response rates for triplet or quadruple regimens varied between 23.5% and 81.9%. Although no significant adverse effects were observed, minor symptoms such as diarrhoea, constipation, sedation and headaches were reported. CONCLUSION Existing evidence on HSCT antiemetic therapy highlights its benefits but fails to provide clear clinical directions. The choice between triplet and quadruplet therapies for different patient scenarios is still uncertain. Until more detailed research is available, healthcare providers must rely on the latest guidelines and their judgement to customise antiemetic care for each patient's specific needs and risks.
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Affiliation(s)
- Nerea Báez-Gutiérrez
- Department of Pharmacy, University Hospital Nuestra Señora de Valme, Seville, Spain
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Belluomini L, Avancini A, Sposito M, Pontolillo L, Tregnago D, Trestini I, Insolda J, Carbognin L, Milella M, Bria E, Pilotto S. Integrating nutrition, physical exercise, psychosocial support and antiemetic drugs into CINV management: The road to success. Crit Rev Oncol Hematol 2024; 201:104444. [PMID: 39002789 DOI: 10.1016/j.critrevonc.2024.104444] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2024] [Revised: 06/26/2024] [Accepted: 07/06/2024] [Indexed: 07/15/2024] Open
Abstract
Over the years, advancements in antiemetic drugs have improved chemotherapy-induced nausea and vomiting (CINV) control. However, despite the antiemetics therapies, in a relevant number of adult patients (∼30 %), CINV is still persistent, leading to several complications, such as electrolyte imbalances, anorexia, and treatment discontinuation. Supportive care interventions have gained credibility in cancer care, helping to improve patients' psycho-physical condition, quality of life, and managing symptoms, including CINV. Physical exercise and tailored nutritional counseling have demonstrated benefits in reducing the severity of nausea and vomiting. Psychological intervention has been postulated as a key approach in controlling anticipatory nausea/vomiting, as well as acupuncture/acupressure has been shown to decrease nausea and vomiting after chemotherapy treatments. In the current review, we aim to provide a clinical update on current prophylactic and delayed antiemetic guidelines for CINV and an overview of the non-pharmacological interventions tested for alleviating CINV in patients with cancer.
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Affiliation(s)
- Lorenzo Belluomini
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Alice Avancini
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Marco Sposito
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Letizia Pontolillo
- UOC Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Medical Oncology, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, Italy.
| | - Daniela Tregnago
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Ilaria Trestini
- Dietetic Service, Hospital Medical Direction, University and Hospital Trust (AOUI) of Verona, Italy.
| | - Jessica Insolda
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Luisa Carbognin
- UOC Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Medical Oncology, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, Italy.
| | - Michele Milella
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Emilio Bria
- UOC Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Medical Oncology, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, Italy.
| | - Sara Pilotto
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
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Albanell-Fernández M, Pérez Sánchez Á, Monge-Escartín I, Riu-Viladoms G, Rodríguez Mues MC, Corominas Bosch ML, Gaba García L, Rollán NB, Reguart N, Soy Muner D, Carcelero San Martín E. Assessment of the change of antiemetic prophylaxis from double to triple combination in patients with high dose carboplatin chemotherapy. J Oncol Pharm Pract 2024; 30:999-1009. [PMID: 37563932 DOI: 10.1177/10781552231194077] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/12/2023]
Abstract
INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) is one of the adverse events that most affects oncologic patients' quality of life. Carboplatin AUC ≥ 4 belongs to agents with high emetic risk (moderate risk in ASCO guidelines). We aimed to compare the effectiveness of netupitant/palonosetron and dexamethasone triple combination (TC) therapy versus ondansetron and dexamethasone double combination (DC) therapy as antiemetic prophylaxis in patients with carboplatin AUC ≥ 4. As a secondary endpoint, in TC group we evaluated the effectiveness of changing NEPA administration timing from 1 h to 15 min before chemotherapy. METHODS Open-label prospective study conducted in a tertiary-care hospital in patients receiving carboplatin AUC ≥ 4. CINV was evaluated using MASCC antiemetic tool, in acute (<24 h) and delayed phase (24-120 h). Results were analyzed using χ2 test. RESULTS Two-hundred four completed questionnaires (CQ) were analyzed (76 in DC and 128 in TC). The proportion of patients who remained emesis-free was superior for TC-treated group compared to DC, either in acute (99.2% vs 92.1%, p = 0.0115) and delayed phase (97.6% vs 90.7%, p = 0.043). Likewise, a higher proportion of TC-treated patients compared to DC remained nausea-free for the first 24 h after treatment (90.6% vs 71%, p = 0.0004) and between 24 and 120 h (82.3% vs 62.7%, p = 0.0025). The change of NEPA administration time showed similar effectiveness in terms of CINV control (81.6% vs 74.5%, p = 0.70). CONCLUSIONS TC showed superiority in early and delayed CINV control in carboplatin AUC ≥ 4 regimens, with no significant differences among cancer types. Change in NEPA administration timing has beneficial implications; it allows NEPA to be administered at hospitals before chemotherapy session.
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Affiliation(s)
| | | | - Inés Monge-Escartín
- Pharmacy Department, Division of Medicines, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Gisela Riu-Viladoms
- Pharmacy Department, Division of Medicines, Hospital Clinic of Barcelona, Barcelona, Spain
| | | | | | - Lydia Gaba García
- Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Neus Basté Rollán
- Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Noemí Reguart
- Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain
| | - Dolors Soy Muner
- Pharmacy Department, Division of Medicines, Hospital Clinic of Barcelona, Barcelona, Spain
- August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
- Department of Pharmacology, Toxicology and Therapeutic Chemistry, School of Pharmacy, University of Barcelona, Barcelona, Spain
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12
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Tian SC, Yang J, Li X, Huang RX, Chen J. Bibliometric and visual analysis of chemotherapy-induced nausea and vomiting (2004-2023). Front Oncol 2024; 14:1377486. [PMID: 38720800 PMCID: PMC11076682 DOI: 10.3389/fonc.2024.1377486] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2024] [Accepted: 04/04/2024] [Indexed: 05/12/2024] Open
Abstract
Background Patients undergoing chemotherapy often encounter troubling and common side effects, notably Chemotherapy-induced nausea and vomiting (CINV). This side effect not only impairs the patient's quality of life but could also result in the interruption or discontinuation of the chemotherapy treatment. Consequently, research into CINV has consistently remained a focal point in the realm of clinical medicine. In this research domain, bibliometric analysis has not been conducted. The purpose of this study is to deliver a thorough summary of the knowledge framework and key areas of interest in the field of Chemotherapy-induced nausea and vomiting, using bibliometric methods. This approach aims to furnish novel concepts and pathways for investigators working in this area. Methods Publications focusing on Chemotherapy-induced nausea and vomiting, spanning from 2004 to 2023, were identified using the Web of Science Core Collection (WoSCC) database. Tools such as VOSviewer, CiteSpace, and the R package "bibliometrix" were employed for this bibliometric analysis. Results This research covers 734 publications from 61 countries, with the United States and China being the primary contributors. There has been a significant rise in the volume of papers published in the most recent decade compared to the one before it, spanning over the past twenty years. However, the annual publication rate in the last ten years has not shown a significant upward trend. The University of Toronto, Merck & Co., Sun Yat-sen University, and Helsinn Healthcare SA emerged as the principal research institutions in this field. Supportive Care in Cancer stands out as the most frequently published and cited journal in this domain. These works are contributed by 3,917 authors, with Rudolph M Navari, Matti Aapro, Shimokawa Mototsugu, and Lee Schwartzberg being among those who have published the most. Paul J. Hesketh is notably the most co-cited author. The primary focus of this research field lies in exploring the mechanisms of CINV and the therapeutic strategies for managing it. Key emerging research hotspots are represented by terms such as "Chemotherapy-induced nausea and vomiting," "nausea," "vomiting," "chemotherapy," and "antiemetics." Conclusion This represents the inaugural bibliometric study to thoroughly outline the research trends and advancements in the field of CINV. It highlights the latest research frontiers and trending directions, offering valuable insights for scholars engaged in studying CINV.
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Affiliation(s)
- Shao-Chuang Tian
- Department of Oncology, The First People’s Hospital of Kunming, Kunming, China
| | - Jing Yang
- Department of Oncology, The First People’s Hospital of Kunming, Kunming, China
| | - Xin Li
- Department of Gynecology, Kunming Maternal and Child Health Hospital, Kunming, China
| | - Rong-Xia Huang
- Department of Gynecology, Kunming Maternal and Child Health Hospital, Kunming, China
| | - Jian Chen
- Department of Gynecology, Kunming Maternal and Child Health Hospital, Kunming, China
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13
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Berg M, Hansson C, Silander E, Bove M, Johansson L, Haugen Cange H, Bosaeus I, Nyman J, Hammerlid E. A randomized study comparing the nutritional effects of radiotherapy with cetuximab versus cisplatin in patients with advanced head and neck cancer. Head Neck 2024; 46:760-771. [PMID: 38192119 DOI: 10.1002/hed.27619] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2023] [Revised: 11/24/2023] [Accepted: 12/18/2023] [Indexed: 01/10/2024] Open
Abstract
BACKGROUND Head and neck cancer (HNC) patients have a high risk of developing malnutrition. This randomized study aimed to compare the effect of weekly cisplatin or cetuximab combined with radiotherapy on weight loss at 3 months after treatment was started. Secondary outcomes were the prevalence of malnutrition using the Global Leadership Initiative on Malnutrition (GLIM) criteria, feeding tube dependence and health related quality of life from a nutritional perspective. METHODS Patients from the ARTSCAN III study with advanced HNC were assessed for weight, body composition, enteral tube dependence and selected quality-of-life scores (EORTC QLQ-C30 and QLQ-H&N35) at diagnosis and 6 weeks 3, 6 and 12 months after treatment initiation. RESULTS Of the 80 patients, 38 and 42 were randomized to receive cetuximab and cisplatin treatment, respectively. There was no significant difference in weight loss at 3 months between the two study groups. However, the cetuximab group had significantly less weight loss, fewer enteral feeding tubes and better physical functioning at the end of treatment but more pain-related problems 3 months after treatment initiation. No differences between the groups were found at 6 and 12 months. The prevalence of malnutrition was not significantly different at any time point. CONCLUSION The hypothesized benefit of concomitant treatment with cetuximab over cisplatin regarding the prevalence of malnutrition was not supported by this study.
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Affiliation(s)
- Malin Berg
- Department of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Otorhinolaryngology-Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Camilla Hansson
- Department of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Otorhinolaryngology-Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Ewa Silander
- Department of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Otorhinolaryngology-Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Mogens Bove
- Department of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Otorhinolaryngology, Head and Neck Surgery, NU-Hospital Group, Trollhättan, Sweden
| | - Leif Johansson
- Department of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Otorhinolaryngology, Head and Neck Surgery, Skas, Skövde, Sweden
| | - Hedda Haugen Cange
- Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Ingvar Bosaeus
- Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Jan Nyman
- Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Eva Hammerlid
- Department of Otorhinolaryngology-Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Otorhinolaryngology-Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
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Perkovich B, Atayee RS, Kim JS, Rubenzik T. Use of Fosaprepitant for Management of Suspected Antimicrobial-Associated Nausea: A Case Report. J Pain Palliat Care Pharmacother 2024; 38:28-32. [PMID: 37983131 DOI: 10.1080/15360288.2023.2282465] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2023] [Accepted: 11/05/2023] [Indexed: 11/22/2023]
Abstract
Intractable nausea can occur in numerous settings. We report on a 49-year-old woman with a past medical history of cystic fibrosis (CF) with chronic hypoxia, chronic nausea, complex infection history and frequent hospitalizations who was admitted to an academic medical center with a CF exacerbation. Her chronic nausea worsened with the use of antimicrobials, and she was unable to tolerate dopamine or serotonin antagonist antiemetics. Nausea persisted despite the use of benzodiazepines and antihistamines. She was given a one-time dose of fosaprepitant 150 mg intravenously (IV) with marked improvement of her nausea. During subsequent exacerbations, she again developed severe nausea which continued to respond well to a one-time dose of fosaprepitant 150 mg IV. Fosaprepitant is a substance P/neurokinin-1 (NK1) receptor antagonist that is FDA-approved for the prevention of chemotherapy-induced nausea and vomiting and has been used to prevent post-operative nausea and vomiting. Its use in other contexts has not been well established. This case suggests a role for fosaprepitant in the management of nausea outside the context of chemotherapy or general anesthesia.
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Affiliation(s)
- Brandon Perkovich
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
| | - Rabia S Atayee
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
- Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA
- San Diego Health, Department of Pharmacy, University of California, San Diego, La Jolla, California, USA
| | - Jennifer S Kim
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
| | - Tamara Rubenzik
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
- Division of Nephrology and Hypertension, University of California San Diego, La Jolla, California, USA
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15
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Lee R, Ku M, Je NK. Adherence to antiemetic guidelines in solid cancer patients receiving highly emetogenic chemotherapy in Korea. Support Care Cancer 2024; 32:190. [PMID: 38400861 DOI: 10.1007/s00520-024-08367-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2023] [Accepted: 02/11/2024] [Indexed: 02/26/2024]
Abstract
BACKGROUND Highly emetogenic chemotherapy (HEC) is known to induce nausea and vomiting (CINV) in approximately 90% of cancer patients undergoing this regimen unless proper prophylactic antiemetics are administered. This study aimed to analyze the use of a three-drug prophylactic antiemetic regimen during the first cycle of chemotherapy and assess the compliance rate with the National Comprehensive Cancer Network (NCCN) guidelines. METHODS This retrospective study utilized data from the National Inpatient Sample database from 2016 to 2020 provided by the Health Insurance Review and Assessment Service. The claims data encompassed 10 to 13% of inpatients admitted at least once each year. Patients with solid cancers treated with two HEC regimens, namely anthracycline + cyclophosphamide (AC) and cisplatin-based regimens, were selected as the study population. We evaluated the use of a three-drug prophylactic antiemetic regimen, including a neurokinin-1 receptor antagonist, a 5-hydroxytryptamine-3 receptor antagonist, and dexamethasone and compliance with the NCCN guidelines. Multiple logistic regression was conducted to estimate the influence of variables on guideline adherence. RESULTS A total of 3119 patients were included in the analysis. The overall compliance rate with the NCCN guidelines for prophylactic antiemetics was 74.3%, with higher rates observed in the AC group (87.9%) and lower rates in the cisplatin group (60.4%). The AC group had a 6.37 times higher likelihood of receiving guideline-adherent antiemetics than the cisplatin group. Further analysis revealed that, compared to 2016, the probability of complying with the guidelines in 2019 and 2020 was 0.72 times and 0.76 times lower, respectively. CONCLUSION This study showed that a considerable proportion of HEC-treated patients received guideline-adherent antiemetic therapies. However, given the variations in adherence rates between different chemotherapy regimens (AC vs. cisplatin), efforts to improve adherence and optimize antiemetic treatment remain essential for providing the best possible care for patients experiencing CINV.
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Affiliation(s)
- Ryugyoung Lee
- College of Pharmacy, Pusan National University, Busan, 46241, Republic of Korea
- Department of Pharmacy, Dongnam Institute of Radiological & Medical Sciences, Busan, Republic of Korea
| | - Minhee Ku
- College of Pharmacy, Pusan National University, Busan, 46241, Republic of Korea
- Department of Pharmacy, Dongnam Institute of Radiological & Medical Sciences, Busan, Republic of Korea
| | - Nam Kyung Je
- College of Pharmacy, Pusan National University, Busan, 46241, Republic of Korea.
- Research Institute for Drug Development, Pusan National University, Busan, 46241, Republic of Korea.
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Liao X, Ye B, Hu W, Han J, Zhao Y, Dai Y, Wu X, Mo Z, Wei L, Nie K. Xiaobanxia decoction alleviates chemotherapy-induced nausea and vomiting by inhibiting GSDME-mediated pyroptosis. JOURNAL OF ETHNOPHARMACOLOGY 2024; 318:116970. [PMID: 37516392 DOI: 10.1016/j.jep.2023.116970] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/16/2023] [Revised: 07/18/2023] [Accepted: 07/26/2023] [Indexed: 07/31/2023]
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Xiaobanxia Decoction (XBXD), a traditional antiemetic formula, is effective in preventing chemotherapy-induced nausea and vomiting (CINV), but its underlying mechanism has not been fully clarified. AIM OF THE STUDY To investigate whether the antiemetic mechanisms of XBXD against CINV is associated with the reduction of GSDME-mediated pyroptosis and the alleviation of gastrointestinal inflammation induced by cisplatin. MATERIALS AND METHODS We established the in vivo pica rat model and the in vitro small intestinal epithelial cell (IEC-6 cell) injury model by cisplatin challenge. The levels of ROS, IL-1β, IL-18, HMGB1 were measured by ELISA. The histopathological changes of gastrointestinal (GI) tissues were examined by HE staining. The expression and localization of GSDME in GI tissues were determined by IHC. The GSDME mRNA expression in GI tissues was determined by RT-PCR. The IEC-6 cell viability was detected by CCK-8. The morphology of IEC-6 cells was observed by optical microscope and scanning electron microscopy. Pyroptosis was examined using Hoechst33342/PI staining. The intracellular ROS levels were measured with the fluorescent probe DCFH-DA. The expression levels of JNK, p-JNK, Bax, Bcl-2, caspase-9, caspase-3 and GSDME in GI tissues and IEC-6 cells were determined by WB. RESULTS We found that the cumulative kaolin intake (pica behavior, analogous to emesis) significantly increased in cisplatin-treated rats, accompanied by significant inflammatory pathological changes of GI tissues. XBXD decreased the cumulative kaolin intake and alleviated GI inflammation in cisplatin-treated rats by inhibiting the activation of the ROS/JNK/Bax signaling pathway and by reducing GSDME-mediated pyroptosis. Additionally, cisplatin damaged IEC-6 cells by activating GSDME-dependent pyroptosis. XBXD reduced GSDME-mediated IEC-6 cell pyroptotic death by regulating the ROS/JNK/Bax signaling pathway. CONCLUSIONS This study suggested that GSDME-mediated pyroptosis greatly contributes to the occurrence of CINV, and suppressing GSDME-mediated pyroptosis is the important antiemetic mechanism of XBXD.
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Affiliation(s)
- Xiuxiu Liao
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Binbin Ye
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Wanting Hu
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Jinyuan Han
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Yaozhong Zhao
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Yongzhao Dai
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Xipei Wu
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Ziyao Mo
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Ling Wei
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China
| | - Ke Nie
- School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, 510006, China.
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Schwartzberg L, Navari RM, Ruddy KJ, LeBlanc TW, Clark-Snow R, Wickham R, Kloth D, Binder G, Bailey WL, Turini M, Potluri R, Liu X, Papademetriou E, Roeland EJ. Work loss and activity impairment due to extended nausea and vomiting in patients with breast cancer receiving CINV prophylaxis. Support Care Cancer 2023; 31:654. [PMID: 37878086 PMCID: PMC10600031 DOI: 10.1007/s00520-023-08119-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2023] [Accepted: 10/13/2023] [Indexed: 10/26/2023]
Abstract
PURPOSE Chemotherapy-induced nausea and vomiting (CINV)'s impact on work loss remains poorly described. We evaluated associations between the duration of CINV episodes, CINV-related work loss (CINV-WL), and CINV-related activity impairment (CINV-AI) in patients with breast cancer receiving highly emetogenic chemotherapy. METHODS We analyzed data from a prospective CINV prophylaxis trial of netupitant/palonestron and dexamethasone for patients receiving an anthracycline and cyclophosphamide (AC) for breast cancer (NCT0340371). Over the observed CINV duration (0-5 days), we analyzed patient-reported CINV-WL and CINV-AI for the first two chemotherapy cycles. We categorized patients as having either extended (≥ 3 days) or short (1-2 days) CINV duration and quantified its impact on work using the Work Productivity and Activity Impairment Questionnaire (WPAI). RESULTS Overall, we captured data for 792 cycles in 402 women, including 136 (33.8%) employed patients with 35.3% reporting CINV. Of those with CINV, patients reported CINV-WL in 26 cycles and CINV-AI in 142 cycles. Of those with CINV, 55.3% of extended CINV cycles experienced CINV-WL compared to 16.7% of short CINV cycles (p < 0.001). The relative risk of CINV-WL between extended and short CINV was 3.32 (p < 0.01) for employed patients. The mean difference in CINV-AI scores (higher = worse) between extended and short duration CINV was 5.0 vs. 3.0 (p < 0.001). CONCLUSION Extended (≥ 3 days) CINV was associated with more than triple the risk of CINV-WL and higher CINV-AI compared with short CINV.
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Affiliation(s)
| | | | | | - Thomas W LeBlanc
- Duke University School of Medicine, Duke Cancer Institute, Durham, NC, USA
| | | | - Rita Wickham
- Rush University College of Nursing, Chicago, IL, USA
| | | | | | | | | | | | - Xing Liu
- Putnam Associates, New York, NY, USA
| | | | - Eric J Roeland
- Oregon Health and Sciences Center, Knight Cancer Institute, Portland, OR, USA
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Xie S, Huang R, Zhan Y, Cai Q, Wu Y, Huang K, Lin X, Wang R, Yan Y, Xie R, Wang S, Zeng C, Chen C. Efficacy of fosaprepitant combined with tropisetron plus dexamethasone in preventing nausea and emesis during fractionated radiotherapy with weekly cisplatin chemotherapy: interim analysis of a randomized, prospective, clinical trial using competing risk analysis. Support Care Cancer 2023; 31:640. [PMID: 37851143 DOI: 10.1007/s00520-023-08111-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2022] [Accepted: 10/09/2023] [Indexed: 10/19/2023]
Abstract
PURPOSE There are no well-recognized guidelines for antiemesis during concurrent chemoradiotherapy (CCRT) for cervical cancer (CC) and nasopharyngeal cancer (NPC) until now. The study was designed to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with CC or NPC. METHODS Patients with CC or NPC were scheduled to receive fractionated radiotherapy and weekly cisplatin (25-40 mg/m2) chemotherapy for at least 5 weeks. Patients stratified by tumor type and induction chemotherapy were 1:1 randomly assigned to receive fosaprepitant, tropisetron, and dexamethasone or tropisetron plus dexamethasone as an antiemetic regimen. Efficacy was assessed primarily by the cumulative incidence of emesis after 5 weeks of treatment, and safety by adverse events (AEs). RESULTS Between July 2020 and July 2022, 116 patients consented to the study of whom 103 were included in this interim analysis (fosaprepitant group [N = 52] vs control group [N = 51]). The cumulative incidence of emesis at 5 weeks (competing risk analysis) was 25% (95% CI 14.2-37.4) for the fosaprepitant group compared with 59% (95% CI 43.9-71.0) for the control group. There was a significantly lower cumulative risk of emesis in the fosaprepitant group (HR 0.35 [95% CI 0.19-0.64]; p < 0.001). Fosaprepitant was well tolerated as the incidences of adverse events in the two groups were comparable. CONCLUSION The addition of fosaprepitant to tropisetron plus dexamethasone significantly reduced the risk of nausea and vomiting during 5 weeks of CCRT in patients with CC or NPC, and fosaprepitant was well tolerated. TRIAL REGISTRATION The trial was registered with ClinicalTrials.gov on October 3, 2022, number NCT05564286.
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Affiliation(s)
- Song Xie
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
- Shantou University Medical College, Shantou, China
| | - Ruihong Huang
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
| | - Yizhou Zhan
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
| | - Qingxin Cai
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
| | - Yanxuan Wu
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
| | - Kang Huang
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
- Department of Radiation Oncology, Zhongshan City People's Hospital, Zhongshan, China
| | - Xiaoluan Lin
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
- Shantou University Medical College, Shantou, China
| | - Ruoheng Wang
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
| | - Yudong Yan
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
- Shantou University Medical College, Shantou, China
| | - Renxian Xie
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
- Shantou University Medical College, Shantou, China
| | - Siyan Wang
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
- Shantou University Medical College, Shantou, China
| | - Chengbing Zeng
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China
| | - Chuangzhen Chen
- Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, China.
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Al-Salloum HF, Al-Harbi HE, Abdelazeem A. Effectiveness of antiemetic in reducing chemotherapy-induced nausea and vomiting in adult patients; An oncology center experience. J Oncol Pharm Pract 2023; 29:1317-1325. [PMID: 36518002 DOI: 10.1177/10781552221118634] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/28/2023]
Abstract
INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) are two serious adverse effect of cancer chemotherapy. The objectives of this study are to assess patient satisfaction with antiemetics prescribed, incidence of nausea and vomiting in cancer patients, and the effectiveness of antiemetic regimens in reducing CINV. METHODS This is a prospective observational cross-sectional patient survey study, conducted between January and July 2021 in the oncology center at King Saud University Medical City, Riyadh, Saudi Arabia. A suitable, data entry form was designed to collect data including patient demographics, cancer type, antiemetics prescribed, chemotherapy regimen, and incidence of CINV. RESULTS The sample comprised 283 cancer patients with a mean age of 47.7 (±14.6) years. Colorectal and breast cancer (n = 67; 23.6%, for each) were the two most common diagnoses. Among the patients who received chemotherapy, most patients (n = 144; 50.8%) received chemotherapy that was classified as highly emetogenic, and 139 (49%) received moderately emetogenic chemotherapy. Antiemetics were given to control CINV before chemotherapy administration (as prophylaxis) were either combination therapy (170 patients (60.0%) received four classes of antiemetics, 72 (25.4%) received three classes; and 31 (10.9%) received two classes) or monotherapy (six patients (2.1%) received one drug). Four patients (1.4%) did not receive any antiemetic medication. Antiemetics given to control CINV after chemotherapy administration (for delayed CINV) were also either in combination (151 patients (53.3%) received three classes of antiemetics and 94 (33.2%) received two classes) or as monotherapy, where 27 patients (9.5%) received one medication. Eleven patients (3.8%) did not receive any antiemetic. The incidence rates for acute and delayed nausea after chemotherapy treatment were 32.1% and 30.7%, respectively; and those for acute and delayed vomiting were 13.4% and 10.2%, respectively. Acute nausea was much more frequent than vomiting. CONCLUSION The incidence of CINV was relatively high, and patients who received chemotherapy continued to experience nausea and vomiting despite receiving antiemetic treatment. This demonstrates that antiemetic regimens used are not effective in preventing CINV.
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Affiliation(s)
- Haya F Al-Salloum
- Department of Pharmacy, King Saud University Medical City, Riyadh, Saudi Arabia
| | | | - Ahmed Abdelazeem
- College of Pharmacy, Riyadh Elm University, Riyadh, Saudi Arabia
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20
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Borner T, Tinsley IC, Milliken BT, Doebley SA, Najjar NR, Kerwood DJ, De Jonghe BC, Hayes MR, Doyle RP. Creation of a Peptide Antagonist of the GFRAL-RET Receptor Complex for the Treatment of GDF15-Induced Malaise. J Med Chem 2023; 66:11237-11249. [PMID: 37506293 PMCID: PMC10461225 DOI: 10.1021/acs.jmedchem.3c00667] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2023] [Indexed: 07/30/2023]
Abstract
Growth differentiation factor 15 (GDF15) is a contributor to nausea, emesis, and anorexia following chemotherapy via binding to the GFRAL-RET receptor complex expressed in hindbrain neurons. Therefore, GDF15-mediated GFRAL-RET signaling is a promising target for improving treatment outcomes for chemotherapy patients. We developed peptide-based antagonists of GFRAL that block GDF15-mediated RET recruitment. Our initial library screen led to five novel peptides. Surface plasmon resonance and flow cytometric analyses of the most efficacious of this group, termed GRASP, revealed its capacity to bind to GFRAL. In vivo studies in rats revealed that GRASP could attenuate GDF15-induced nausea and anorexia resulting from cisplatin. Combined with Ondansetron, GRASP led to an even greater attenuation of the anorectic effects of cisplatin compared to either agent alone. Our results highlight the beneficial effects of GRASP as an agent to combat chemotherapy-induced malaise. GRASP may also be effective in other conditions associated with elevated levels of GDF15.
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Affiliation(s)
- Tito Borner
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
- Department
of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Ian C. Tinsley
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Brandon T. Milliken
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Sarah A. Doebley
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Nicholas R. Najjar
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Deborah J. Kerwood
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Bart C. De Jonghe
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
- Department
of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Matthew R. Hayes
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
- Department
of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Robert P. Doyle
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
- Departments
of Medicine and Pharmacology, State University
of New York, Upstate Medical University, Syracuse, New York 13245, United States
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21
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Chow R, Yin LB, Baqri W, Huang R, Boldt G, Younus J, Lock M, Prsic E, Zimmermann C, Herrstedt J. Prevalence and predictors of long-delayed (> 120 h) chemotherapy-induced nausea and vomiting (CINV)-a systematic review and individual patient data meta-analysis. Support Care Cancer 2023; 31:505. [PMID: 37535218 DOI: 10.1007/s00520-023-07978-y] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2023] [Accepted: 07/28/2023] [Indexed: 08/04/2023]
Abstract
INTRODUCTION Although there have been reports of chemotherapy-induced nausea and vomiting (CINV) beyond 120 h, its overall prevalence has not been systematically examined. The aim of this review and meta-analysis was to report on the prevalence of this long-delayed CINV. METHODS This review was registered on PROSPERO (CRD42022346963). PubMed (Medline), Embase, and Cochrane Central were searched from inception until August 2022. Articles were included if they reported on CINV > 120 h after initiation of the chemotherapy regimen and patients received a single-agent highly emetogenic (HEC) or moderately emetogenic (MEC) antineoplastic agent for 1 day alone or in combination with low/minimal emetogenic chemotherapy. For all eligible articles, individual study authors were contacted and requested to provide individual patient-level data of demographics, emetogenicity of chemotherapy regimens, and daily incidence of nausea and vomiting. Forward stepwise logistic regression identified predictors for the incident day's CINV based on prior day's CINV episodes, controlling for patient demographics, and stratified by regimen emetogenicity. RESULTS A total of 2048 patients from 2 studies were included in this individual patient data meta-analysis: 1333 patients (65%) received HEC and 715 (35%) received MEC. Among those receiving HEC, 325 (24%) experienced acute, 652 (49%) delayed, and 393 (31%) long-delayed nausea; 107 (8%) experienced acute, 179 (14%) delayed, and 79 (6%) long-delayed vomiting. Among those receiving MEC, 48 (7%) experienced acute, 272 (38%) delayed, and 167 (24%) long-delayed nausea; 12 (2%) experienced acute, 97 (14%) delayed, and 42 (6%) long-delayed vomiting. Nausea in the long-delayed phase was as severe as in the delayed phase. Patients experiencing nausea and vomiting on days 4 and 5 were at significant risk of experiencing long-delayed CINV. CONCLUSION While not as prevalent as delayed nausea and vomiting, long-delayed CINV affects a significant proportion of patients and severity is similar. Patients with delayed CINV, specifically on days 4-5, are at risk of experiencing long-delayed CINV.
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Affiliation(s)
- Ronald Chow
- Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
| | - Leyi Bellinda Yin
- Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | - Wafa Baqri
- Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | - Ryan Huang
- Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | - Gabriel Boldt
- Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - Jawaid Younus
- Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - Michael Lock
- Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada
| | - Elizabeth Prsic
- Yale School of Medicine, Yale University, New Haven, CT, USA
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Gao A, Guan S, Sun Y, Wang L, Meng F, Liu X, Gu L, Li G, Zhong D, Zhang L. Prolonged usage of fosaprepitant for prevention of delayed chemotherapy-induced nausea and vomiting(CINV) in patients receiving highly emetogenic chemotherapy. BMC Cancer 2023; 23:609. [PMID: 37393241 DOI: 10.1186/s12885-023-11070-3] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2022] [Accepted: 06/14/2023] [Indexed: 07/03/2023] Open
Abstract
BACKGROUND Even though chemotherapy-induced nausea and vomiting (CINV) can be well controlled in the acute phase, the incidence of delayed CINV remains high. In this study, we intend to investigate whether prolonged use of NK-1 receptor antagonist (RA) in addition to 5-HT3 RA and dexamethasone (DEX) was more effective in preventing delayed CINV. METHODS This randomised, open-label, controlled study was designed to compare the efficacy and safety of fosaprepitant 150 mg given on days 1,3 (prolonged group) versus on day 1 (regular group) in patients receiving highly emetogenic chemotherapy (HEC). All patients also treated with palonosetron on day 1 and DEX on days 1-3. The primary endpoint was the incidence of delayed nausea and vomiting. The second endpoint was AEs. All the above endpoints were defined according to CTCAE 5.0. RESULTS Seventy-seven patients were randomly assigned to prolonged group and seventy-nine to regular group. Prolonged group demonstrated superiority in controlling delayed CINV to regular group, with statistically significant lower incidence of nausea (6.17% vs 12.66%, P = 0.0056), and slightly lower incidence of grade 1 vomiting (1.62% vs 3.80%, P = 0.0953) in the delayed phase. In addition, prolonged use of fosaprepitant was safe. No significant difference was found between the two groups regarding constipation, diarrhea, hiccough, fatigue, palpitation and headache in delayed phase. CONCLUSIONS Prolonged use of fosaprepitant can effectively and safely prevent delayed CINV in patients receiving HEC.
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Affiliation(s)
- Ai Gao
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Shasha Guan
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Yinjuan Sun
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Lingling Wang
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Fanlu Meng
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Xia Liu
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Liyan Gu
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Guo Li
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China
| | - Diansheng Zhong
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China.
| | - Linlin Zhang
- Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshan Dao, Heping District, Tianjin, 300052, China.
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Lee M, Kang D, Kang E, Kim S, Kim Y, Ahn JS, Park S, Lee YY, Oh D, Noh JM, Cho J. Efficacy of the PRO-CTCAE mobile application for improving patient participation in symptom management during cancer treatment: a randomized controlled trial. Support Care Cancer 2023; 31:321. [PMID: 37148373 PMCID: PMC10163577 DOI: 10.1007/s00520-023-07779-3] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2022] [Accepted: 04/25/2023] [Indexed: 05/08/2023]
Abstract
PURPOSE Although mobile-based symptom monitoring is expected to improve patient participation in symptom management during anticancer therapy, previous trials have not evaluated its effectiveness. Therefore, this study aims to evaluate the impact of a symptom monitoring mobile application on improving patient participation in symptom management during anticancer therapy. METHODS We conducted a single-center, open-label, randomized controlled trial that enrolled patients with breast, lung, head and neck, esophageal, or gynecologic cancer who were scheduled to receive anticancer therapy (oral or intravenous) between October 2020 and March 2021. We excluded patients with physical or psychological problems. The intervention group received a symptom monitoring application for 8 weeks, and the control group received the usual clinical practice. At 8 weeks, the improvement in patient participation in symptom management was assessed, and additionally quality of life and unplanned clinical visits were assessed. RESULTS A total of 222 patients were included in the analysis, of whom 142 were randomly assigned to the intervention group and 71 to the control group. The intervention group reported better outcome in patient participation in symptom management than the control group at 8 weeks (mean scores of 8.5 vs. 8.0; P = 0.01). There were no significant differences between the groups in Quality of life (P = 0.88) and unplanned clinical visits (P = 0.39-0.76). CONCLUSIONS This study is meaningful in figuring out that the mobile-based symptom monitoring made them more engaged in their management. Future research should continue to evaluate the effects of patient participation as mediators of clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov NCT04568278.
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Affiliation(s)
- Mangyeong Lee
- Department of Digital Health, SAIHST, Sungkyunkwan University, Seoul, Korea
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Danbee Kang
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Korea
| | - Eunjee Kang
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea
| | - Sooyeon Kim
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Korea
| | - Youngha Kim
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jin Seok Ahn
- Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Sehhoon Park
- Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Yoo-Young Lee
- Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Dongryul Oh
- Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jae Myung Noh
- Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Juhee Cho
- Department of Digital Health, SAIHST, Sungkyunkwan University, Seoul, Korea.
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Korea.
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24
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Chemotherapy: how to reduce its adverse effects while maintaining the potency? Med Oncol 2023; 40:88. [PMID: 36735206 DOI: 10.1007/s12032-023-01954-6] [Citation(s) in RCA: 59] [Impact Index Per Article: 29.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2022] [Accepted: 01/18/2023] [Indexed: 02/04/2023]
Abstract
Chemotherapy is one of the widely used anticancer treatments that involves the use of powerful cytotoxic drugs to stop tumor growth by targeting rapidly dividing cells through various mechanisms, which will be elucidated in this review. Introduced during the early twentieth century, chemotherapy has since lengthened the longevity of innumerable cancer patients. However, the increase in lifespan is at the expense of quality of life as patients are at risk of developing short-term and long-term side effects following chemotherapy, such as alopecia (hair loss), chemotherapy-induced peripheral neuropathy, chemotherapy-induced nausea and vomiting, cardiotoxicity, diarrhea, infertility, and chemo brain. Currently, a number of these chemotherapy-induced adverse effects are managed through supportive care and approved treatments, while the rest of the side effects are unavoidable. Hence, chemotherapeutic drugs associated with inevitable side effects are only administered when their therapeutic role outweighs their chemotoxicity, thus severely limiting the potency of chemotherapy in treating malignancy. Therein, the potential approaches to alleviating side effects of chemotherapy ranging from pharmaceutical drugs to alternative therapies will be discussed in this review in hopes of increasing the tolerance and effectiveness of future chemotherapeutic treatments.
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25
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Khoirunnisa SM, Suryanegara FDA, Setiawan D, Postma MJ. Health-related quality of life in Her2-positive early breast cancer woman using trastuzumab: A systematic review and meta-analysis. Front Pharmacol 2023; 14:1090326. [PMID: 37124232 PMCID: PMC10140570 DOI: 10.3389/fphar.2023.1090326] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2022] [Accepted: 03/31/2023] [Indexed: 05/02/2023] Open
Abstract
Background: Despite the benefits of trastuzumab in many trials, evidence of its impact on health-related quality of life (HRQoL) in early treatment has not been summarized. This study explored the effects of trastuzumab treatment on HRQoL, including pooled meta-analysis, in an effort to provide an integrated assessment of HRQoL for Her2-positive early breast cancer patients. Methods: A comprehensive literature review to February 2023 using three databases, focusing on treatment using trastuzumab during the early stage, was performed. The mean changes from baseline during and after treatment were extracted from the included randomized control trials (RCTs) papers and total HRQoL scores were obtained from cross-sectional studies included. Mean difference (MD) and 95% confidence intervals were assessed by a random effect or fixed effect model based on heterogeneity (I2). Results: A total of ten studies were identified and reviewed, consisting of seven RCTs and three cross-sectional studies. The pooled analysis of the mean change from baseline during treatment resulted in an MD of 1.92 (95% CI = 1.59 to 2.25, p < 0.05, I2 = 0%), favoring the trastuzumab group. A non-significant result of the mean change from baseline after treatment appeared in the analysis of 12-month follow-up. In the cross-sectional studies, pooled analyses of HRQoL showed that trastuzumab meaningfully demonstrated an improved HRQoL profile (MD = 9.29, 95% CI = 1.31 to 17.27, p = 0.02, I2 = 0%). Conclusion: Trastuzumab as a targeted therapy resulted in a favorable effect on HRQoL in the early stages of Her2-positive breast cancer. The findings of significant improvements in patients' HRQoL and less clinically meaningful deterioration in side effects of trastuzumab-containing regimen during treatment were supported by prolonged survival.
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Affiliation(s)
- Sudewi Mukaromah Khoirunnisa
- Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
- Department of Pharmacy, Institut Teknologi Sumatera, Lampung Selatan, Indonesia
- *Correspondence: Sudewi Mukaromah Khoirunnisa, ,
| | - Fithria Dyah Ayu Suryanegara
- Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
- Department of Pharmacy, Universitas Islam Indonesia, Yogyakarta, Indonesia
| | - Didik Setiawan
- Faculty of Pharmacy, Universitas Muhammadiyah Purwokerto, Banyumas, Indonesia
- Center for Health Economic Studies, Universitas Muhammadiyah Purwokerto, Banyumas, Indonesia
| | - Maarten Jacobus Postma
- Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
- Department of Economics, Econometrics and Finance, University of Groningen, Groningen, Netherlands
- Department of Pharmacology and Therapy, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
- Centre of Excellence in Higher Education for Pharmaceutical Care Innovation, Universitas Padjadjaran, Bandung, Indonesia
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Shin Y, Kim B, Kim W. Cisplatin-Induced Nausea and Vomiting: Effect of Herbal Medicines. PLANTS (BASEL, SWITZERLAND) 2022; 11:3395. [PMID: 36501434 PMCID: PMC9736559 DOI: 10.3390/plants11233395] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 10/11/2022] [Revised: 11/26/2022] [Accepted: 12/02/2022] [Indexed: 06/17/2023]
Abstract
Cisplatin is a chemotherapeutic agent that is widely used to treat various types of cancers. However, its side effects, most commonly nausea and vomiting, limit its widespread use. Although various drugs, such as ondansetron and aprepitant, are used to alleviate these side effects, their efficacy is still debated. This review aims to summarize the results of 14 studies on the effects of seven single herbal extracts, one multiple herbal extract, and one ginger sub-component (i.e., [6]-gingerol) on cisplatin-induced nausea and vomiting. The results of the included studies were subdivided into four categories: kaolin consumption, retching and vomiting, food intake, and weight loss. Most studies used rodents, whereas four studies used minks or pigeons. The doses of cisplatin used in the studies varied from 3 mg/kg to 7.5 mg/kg, and only a single injection was used. Nine studies analyzed the mechanisms of action of herbal medicines and assessed the involvement of neurotransmitters, cytokines, enzymes, and various hematological parameters. Although further research is needed, this review suggests herbal medicine as a viable treatment option for cisplatin-induced neuropathic pain.
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Affiliation(s)
- Yuchan Shin
- Department of Physiology, College of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea
| | - Bonglee Kim
- Korean Medicine-Based Drug Repositioning Cancer Research Center, College of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea
| | - Woojin Kim
- Department of Physiology, College of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea
- Korean Medicine-Based Drug Repositioning Cancer Research Center, College of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea
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Tyler T, Schultz A, Venturini A, Giuliano C, Bernareggi A, Spezia R, Voisin D, Stella V. Challenges in the Development of Intravenous Neurokinin-1 Receptor Antagonists: Results of a Safety and Pharmacokinetics Dose-Finding, Phase 1 Study of Intravenous Fosnetupitant. Clin Pharmacol Drug Dev 2022; 11:1405-1418. [PMID: 36263927 PMCID: PMC10092591 DOI: 10.1002/cpdd.1183] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2022] [Accepted: 09/18/2022] [Indexed: 01/28/2023]
Abstract
Oral NEPA is the fixed-combination antiemetic comprising netupitant (neurokinin-1 receptor antagonist [NK1 RA]) and palonosetron (5-hydroxytryptamine-3 receptor antagonist [5-HT3 RA]). Intravenous (IV) NEPA, containing fosnetupitant, a water-soluble N-phosphoryloxymethyl prodrug of netupitant, has been developed. Fosnetupitant does not require excipients or solubility enhancers often used to increase IV NK1 RA water solubility, preventing the occurrence of hypersensitivity and infusion-site reactions associated with these products. In this phase 1 study, subjects received a 30-minute placebo or fosnetupitant (17.6-353 mg) infusion and an oral NEPA or placebo capsule, with 2-sequence crossover treatment for fosnetupitant 118- to 353-mg dose cohorts. IV fosnetupitant safety and pharmacokinetics were evaluated, and its equivalence to an oral netupitant 300-mg dose was defined. Overall, 158 healthy volunteers were enrolled. All adverse events (AEs) were mild or moderate in intensity. Doppler-identified infusion-site asymptomatic thrombosis occurred in 5.4% (fosnetupitant) and 1.2% (oral NEPA) of subjects. The frequency or number of treatment-related AEs did not increase with ascending fosnetupitant doses. The most common treatment-related AEs were headache (fosnetupitant, 8.1%; oral NEPA, 12.7%) and constipation (fosnetupitant, 1.4%; oral NEPA, 7.5%). A fosnetupitant 235-mg dose was equivalent, in terms of netupitant exposure, to 300-mg oral netupitant. The safety profile of a single fosnetupitant 235-mg infusion was similar to that of single-dose oral NEPA.
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Affiliation(s)
- Timothy Tyler
- Comprehensive Cancer Center, Desert Regional Medical Center, Palm Springs, California, USA
| | - Armin Schultz
- CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany
| | | | | | | | | | | | - Valentino Stella
- Pharmaceutical Chemistry, The University of Kansas, Lawrence, Kansas, USA
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Moothedath AW, Meena JP, Gupta AK, Velpandian T, Pandey RM, Seth R. Efficacy and Safety of Olanzapine in Children Receiving Highly Emetogenic Chemotherapy: A Randomized, Double-blind Placebo-controlled Phase 3 Trial. J Pediatr Hematol Oncol 2022; 44:446-453. [PMID: 35091522 DOI: 10.1097/mph.0000000000002408] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/11/2021] [Accepted: 12/26/2021] [Indexed: 11/26/2022]
Abstract
BACKGROUND In this trial, we evaluated the safety and efficacy of olanzapine in children receiving highly emetogenic chemotherapy. MATERIALS AND METHODS In this study, patients aged 3 to 18 years were randomly assigned to either the olanzapine group or the placebo group. All patients received intravenous ondansetron and dexamethasone 30 minutes before highly emetogenic chemotherapy, followed by oral ondansetron for 48 hours. Participants in the olanzapine group received olanzapine once daily on days 1 and 2, while those in the control group received a placebo in the same dosage and schedule. The primary objective was: (a) to compare the complete control rates of vomiting in the delayed phase and (b) to compare the complete control rates of vomiting in acute and overall phases. The secondary objective was to evaluate the safety of olanzapine and the need for rescue medications. RESULTS A total of 128 patients were randomly assigned either to the olanzapine group (n=63) or the control group (n=65). Complete control of vomiting between olanzapine and placebo group was 73% versus 48% ( P =0.005) in the delayed phase, 60% versus 54% ( P =0.46) in the acute phase, and 48% versus 34% ( P =0.117) in the overall phase, respectively. Grades 1 and 2 sedation was greater in the olanzapine group (46% vs. 14%; P <0.001). A significantly higher proportion of patients in the placebo group required rescue medications for vomiting compared with in the olanzapine group ( P =0.025). CONCLUSIONS Olanzapine significantly improved complete control of vomiting in the delayed phase. A considerably lesser proportion of patients in the olanzapine group needed rescue medications.
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Affiliation(s)
| | | | - Aditya K Gupta
- Division of Pediatric Oncology, Department of Pediatrics
| | | | - Ravindra M Pandey
- Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, Delhi, India
| | - Rachna Seth
- Division of Pediatric Oncology, Department of Pediatrics
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Nilsson J, Piovesana V, Turini M, Lezzi C, Eriksson J, Aapro M. Cost-effectiveness analysis of NEPA, a fixed-dose combination of netupitant and palonosetron, for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting: an international perspective. Support Care Cancer 2022; 30:9307-9315. [PMID: 36074186 PMCID: PMC9633536 DOI: 10.1007/s00520-022-07339-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Accepted: 08/13/2022] [Indexed: 01/05/2023]
Abstract
PURPOSE The aim of this study was to assess the cost-effectiveness of NEPA, a fixed-dose combination of oral netupitant (300 mg) and palonosetron (0.5 mg), compared to available treatments in Spain after aprepitant generic introduction in the market, and to discuss results in previously performed analyses in different wordwide settings. METHODS A Markov model including three health states, complete protection, complete response at best and incomplete response, was used to evaluate the cost-effectiveness of NEPA versus common treatment options in Spain during 5 days after chemotherapy. Incremental costs including treatment costs and treatment failure management cost as well as incremental effects including quality adjusted life days (QALDs) and emesis-free days were compared between NEPA and the comparator arms. The primary outcomes were cost per avoided emetic event and cost per QALDs gained. RESULTS NEPA was dominant (more effective and less costly) against aprepitant combined with palonosetron, and fosaprepitant combined with granisetron, while, compared to generic aprepitant plus ondansetron, NEPA showed an incremental cost per avoided emetic event of €33 and cost per QALD gained of €125. CONCLUSION By most evaluations, NEPA is a dominant or cost-effective treatment alternative to current antiemetic standards of care in Spain during the first 5 days of chemotherapy treatment in cancer patients, despite the introduction of generics. These results are in line with previously reported analyses throughout different international settings.
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Affiliation(s)
| | | | | | | | | | - Matti Aapro
- Genolier Cancer Centre, Clinique de Genolier, Genolier, Switzerland
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Sra MS, Ganguly S, Sasi A, Sharma P, Giri RK, Rasheed AA, Bakhshi S. Cost-effectiveness analysis of aprepitant-based anti-emetic regimen for children receiving highly emetogenic chemotherapy: Individual patient data analysis of a randomized trial. Pediatr Blood Cancer 2022; 69:e29795. [PMID: 35652531 DOI: 10.1002/pbc.29795] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/29/2022] [Revised: 05/02/2022] [Accepted: 05/06/2022] [Indexed: 11/07/2022]
Abstract
BACKGROUND Aprepitant has been shown to reduce chemotherapy-induced nausea and vomiting in children receiving highly emetogenic chemotherapy (HEC). In this study, we assessed the cost-effectiveness of aprepitant for children receiving HEC in India, United Kingdom, and the United States. PROCEDURE We utilized individual patient-level outcome data from a pediatric randomized trial, which demonstrated the superiority of an aprepitant-based anti-emetic prophylaxis over standard ondansetron and dexamethasone for HEC. Health state for each day of follow-up was analyzed and quality-adjusted life years (QALYs) were estimated. The incremental cost-utility ratio (ICUR), incremental cost-effectiveness ratio (ICER), and net monetary benefit (NMB) for each country were estimated. Sensitivity analyses by varying cost of aprepitant, hospitalization, and health state utility values by ±25% were conducted. RESULTS Use of the aprepitant-based regimen resulted in gain of 0.0019 QALY per chemotherapy cycle along with cost savings of $22.25, $1335.52, and $6612.10 for India, United Kingdom, and the United States, respectively. The cost savings per QALY was estimated to be $12,355.84 for India, $734,282.90 for the United Kingdom, and $3,567,564.11 for the United States. The cost savings for 50% gain in the percentage of days without grade 3 vomiting was $124.18 for India, $7451.63 for the United Kingdom, and $36,892.76 for the United States. The NMB for gain in QALY was $33.62, $1418.60, and $6727.01 for India, United Kingdom, and the United States, respectively. The estimates remained cost-effective across all scenarios of the sensitivity analyses. CONCLUSION Aprepitant-based anti-emetic regimen is cost-effective for children receiving HEC. It results in overall cost savings and reduced healthcare-resource utilization.
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Affiliation(s)
- Manraj Singh Sra
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| | - Shuvadeep Ganguly
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| | - Archana Sasi
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| | - Priya Sharma
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| | - Rupak Kumar Giri
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| | - Azgar Abdul Rasheed
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
| | - Sameer Bakhshi
- Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
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Effectiveness of Virtual Reality Vs Guides imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Eur J Oncol Nurs 2022; 61:102188. [DOI: 10.1016/j.ejon.2022.102188] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2022] [Revised: 07/30/2022] [Accepted: 08/02/2022] [Indexed: 11/19/2022]
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Takemura M, Ikemura K, Kondo M, Yamane F, Ueda M, Okuda M. Concomitant palonosetron ameliorates cisplatin-induced nephrotoxicity, nausea, and vomiting: a retrospective cohort study and pharmacovigilance analysis. J Pharm Health Care Sci 2022; 8:21. [PMID: 35909131 PMCID: PMC9341052 DOI: 10.1186/s40780-022-00252-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2022] [Accepted: 07/21/2022] [Indexed: 11/15/2022] Open
Abstract
Background Cisplatin (CDDP)-induced nephrotoxicity is the most important complication of CDDP treatment. 5-Hydroxytryptamine type 3 receptor antagonists (5-HT3RAs) are widely used to prevent chemotherapy-induced nausea and vomiting (CINV). However, in patients with the triple antiemetic (neurokinin-1 receptor antagonist, 5-HT3RA, and dexamethasone) therapy, the advantage of palonosetron in comparison with other 5-HT3RAs on CDDP-induced nephrotoxicity and CINV remains unclear. In the present study, we investigated the effect of palonosetron on CDDP-induced nephrotoxicity and CINV in patients with the triple antiemetic therapy by a retrospective cohort study and a pharmacovigilance analysis. Methods We retrospectively analyzed the effect of 5-HT3RAs on the development of nephrotoxicity and CINV in 110 patients who received CDDP, fluorouracil, and triple antiemetic therapy for the treatment of esophageal cancer. Moreover, the effect of 5-HT3RAs on CDDP-induced nephrotoxicity was validated in patients with the triple antiemetic therapy using the Japanese Adverse Drug Event Report (JADER) database. Results In a retrospective study, the incidence of nephrotoxicity (≥ grade 1) in patients receiving palonosetron (18%) was significantly lower than that in patients receiving ramosetron (another 5-HT3RA) (36%, p = 0.044). Moreover, severe nephrotoxicity ≥ grade 3 was observed in one patient treated with ramosetron, whereas hematological toxicity was comparable between the two groups (p = 0.553). Furthermore, the incidence rate of CINV within 120 h following CDDP administration in patients treated with palonosetron (18%) was significantly lower than that in patients receiving ramosetron (39%, p = 0.026). JADER database analyses revealed that the reporting odds ratio of palonosetron for CDDP-induced acute kidney injury was 0.282 (95% confidence interval: 0.169–0.472). Conclusions The findings of the present study suggested a greater potential of palonosetron against CDDP-induced nephrotoxicity and CINV than other 5-HT3RAs in patients with the triple antiemetic therapy.
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Affiliation(s)
- Miho Takemura
- Department of Clinical Pharmacy Research and Education, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan
| | - Kenji Ikemura
- Department of Pharmacy, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan. .,Department of Hospital Pharmacy, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan.
| | - Masayoshi Kondo
- Department of Hospital Pharmacy, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan
| | - Fumihiro Yamane
- Department of Hospital Pharmacy, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan
| | - Mikiko Ueda
- Department of Clinical Pharmacy Research and Education, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan
| | - Masahiro Okuda
- Department of Pharmacy, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan.,Department of Hospital Pharmacy, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan
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Yaguchi-Saito A, Kaji Y, Matsuoka A, Okuyama A, Fujimori M, Saito J, Odawara M, Otsuki A, Uchitomi Y, Zenda S, Shimazu T. Factors affecting the implementation of guideline-based prophylactic antiemetic therapy for chemotherapy-induced nausea and vomiting in Japan: a protocol for a hospital-based qualitative study. BMJ Open 2022; 12:e055473. [PMID: 35667723 PMCID: PMC9171222 DOI: 10.1136/bmjopen-2021-055473] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022] Open
Abstract
INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) decrease patients' quality of life and negatively impact treatment outcomes. Although standard prophylactic antiemetic therapy for acute CINV recommended by guidelines is effective, poor guideline implementation is a worldwide problem. In Japan, prophylactic antiemetic therapy is relatively well implemented for chemotherapy associated with high emetogenic risk, while implementation gaps are observed for that with low emetogenic risk.Although most reports on factors influencing appropriate antiemetic prescription focus on physicians' attitudes and behaviours, a more comprehensive exploration is needed since chemotherapy is expected to involve pharmacists, nurses and eventually hospital directors. The purpose of this qualitative study is to comprehensively explore the factors that influence the implementation of appropriate prophylactic antiemetic procedures at cancer care hospitals in Japan. METHODS AND ANALYSIS This study is a hospital-based qualitative study using semistructured individual interviews. The target population will be hospital directors, and chiefs (including proxies) of departments of oncology and/or chemotherapy, pharmacy and nursing, working in the hospitals, selected by purposive sampling. We will obtain information on antiemetics in chemotherapy regimens, antiemetic routine use and awareness of guidelines using prequestionnaires. Interviews will then be conducted online using an interview guide. The Consolidated Framework for Implementation Research will be used to collect and analyse the interview data. We will also create new codes inductively, as required. In addition, we will refer to the aggregate results of the Quality Indicator survey to determine the implementation of recommended antiemetic prescriptions for each hospital and discuss the relationship with influencing factors. ETHICS AND DISSEMINATION This study has been approved by the National Cancer Centre Ethics Approval Committee (approval number: 2020-305). The study findings will be disseminated via peer-reviewed journal publications and presentations to academics, policy-makers, and clinicians at scientific conferences.
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Affiliation(s)
- Akiko Yaguchi-Saito
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
- Faculty of Human Sciences, Tokiwa University, 1-430-1, Miwa, Mito-shi, Ibaraki, 310-8585, Japan
| | - Yuki Kaji
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Ayumu Matsuoka
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Ayako Okuyama
- Center for Cancer Control and Information Services, National Cancer Center Japan, Chuo-ku, Tokyo, 104-0045, Japan
- Graduate school of Nursing Science, St. Luke's International University, 10-1 Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
| | - Maiko Fujimori
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Junko Saito
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Miyuki Odawara
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Aki Otsuki
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Yosuke Uchitomi
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
| | - Sadamoto Zenda
- Radiation Oncology, National Cancer Center-Hospital East, Kashiwa, Chiba, 277-8577, Japan
| | - Taichi Shimazu
- Division of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, 5-1-1 Tsukiji,Chuo-ku, Tokyo, 104-0045, Japan
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Okuyama A, Takemura Y, Sasaki M, Goto A. Certified nurse specialists in cancer nursing and prophylactic antiemetic prescription for chemotherapy patients. Support Care Cancer 2022; 30:5931-5937. [PMID: 35391572 DOI: 10.1007/s00520-022-07019-0] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Accepted: 03/25/2022] [Indexed: 11/26/2022]
Abstract
PURPOSE The prevention of chemotherapy-induced nausea and vomiting (CINV), a common chemotherapy side effect, should be attempted by oncology nurses. Certified nurses could be certified nurse specialists in cancer nursing (CNSCNs), who have high-level graduate education, or certified nurses in cancer chemotherapy nursing (CNCCNs), who have short-term training. The relationship between these certifications and compliance with the CINV prevention guidelines has not been investigated. We aimed to evaluate the association between certified nurse staffing and prescription of prophylactic antiemetic drugs for chemotherapy patients with high emetic risk. METHODS We used health service utilisation data for cancer patients diagnosed in 2016 from 474 hospitals nationwide in Japan and a list of certified nurses published by the Japanese Nurse Association. Patients receiving highly emetic chemotherapy were included. A multilevel mixed-effect logistic regression analysis was conducted to estimate the prescription of prophylactic antiemetic drugs associated with CNSCN and/or CNCCN staffing. RESULTS Data of 46,306 patients were analysed. Overall, 68.4% and 94.0% of the patients received chemotherapy at hospitals with CNSCNs and CNCCNs, respectively. Small cell lung cancer, non-small cell lung cancer, breast cancer, and oesophageal cancer were positively associated with the prescription of recommended antiemetic drugs. CNSCNs was significantly associated with the prescription of prophylactic antiemetic drugs, while CNCCNs was positively but non-significantly associated with antiemetic prescriptions. CONCLUSION This study is the first to demonstrate that CNSCN placement was significantly associated with prescribing antiemetic drugs recommended by clinical guidelines. Patients are likely to receive appropriate supportive care with the proper placement of CNSCNs.
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Affiliation(s)
- Ayako Okuyama
- National Cancer Center Institute for Cancer Control, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
- St. Luke's International University, 10-1 Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan.
| | - Yukie Takemura
- Division of Health Sciences and Nursing, Graduate School of Medicine, University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
| | - Minako Sasaki
- Division of Nursing, Faculty of Healthcare, Tokyo Healthcare University, 4-1-17 Higashigotanda Shinagawa-ku, Tokyo, 141-8648, Japan
| | - Atsushi Goto
- Department of Health Data Science, Graduate School of Data Science, Yokohama City University, Yokohama, 22-2. Kanazawa-ku Seto, Yokohama-shi, Kanagawa, 236-0027, Japan
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Schilling J, Kurbacher CM, Hanusch C, Busch S, Holländer M, Kreiss-Sender J, Rezek D, Flahaut E, Karthaus M. Quality of Life Effects of an Oral Fixed Combination of Netupitant and Palonosetron in Chemotherapy-Induced Nausea and Vomiting Prevention: Real-World Evidence in Patients with Breast Cancer Receiving Anthracycline-Cyclophosphamide-Based Chemotherapy. Breast Care (Basel) 2022; 17:130-136. [PMID: 35702496 PMCID: PMC9149467 DOI: 10.1159/000514891] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2020] [Accepted: 01/14/2021] [Indexed: 01/29/2024] Open
Abstract
Introduction In a prospective non-interventional study involving 2,173 patients, we showed that use of the oral fixed combination of netupitant 300 mg and palonosetron 0.5 mg (NEPA) for prevention of chemotherapy (Ctx)-induced nausea and vomiting has beneficial effects on the quality of life (QoL) of patients with various types of cancers receiving highly or moderately emetogenic Ctx. Here, we report on the effects on QoL, effectiveness, and tolerability of NEPA in patients with breast cancer exposed to anthracycline-cyclophosphamide (AC)-based Ctx. Methods This is a post hoc subanalysis of a prospective non-interventional study in 1,197 patients with breast cancer receiving up to 3 cycles of doxorubicin or epirubicin plus cyclophosphamide and NEPA. NEPA administration was per the summary of product characteristics. Results In cycle 1 of Ctx, a large proportion of patients (84%) reported "no impact on daily life" (NIDL) due to vomiting; 53% of patients reported NIDL due to nausea. The complete response rate was 86/88/81% in the acute/delayed/overall phase in cycle 1, and NEPA was well tolerated throughout the study. Conclusion The real-world beneficial effects of NEPA prophylaxis on QoL were confirmed for patients with breast cancer receiving AC. NEPA was effective with a good safety profile in this patient population in clinical practice.
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Affiliation(s)
| | - Christian M. Kurbacher
- Gynecology I (Gynecologic Oncology), Gynecologic Center Bonn-Friedensplatz, Bonn, Germany
| | - Claus Hanusch
- Department of Gynecology, Rotkreuzklinikum München, Munich, Germany
| | | | | | | | - Daniela Rezek
- Breast Cancer Center Hamburg at Marien-Hospital Wesel, Wesel, Germany
| | - Elisa Flahaut
- Department of Medical Affairs, RIEMSER Pharma GmbH, Berlin, Germany
| | - Meinolf Karthaus
- Department of Hematology, Oncology and Palliative Care, Klinikum Neuperlach, Munich, Germany
- Department of Hematology, Oncology and Palliative Care, Klinikum Harlaching, Munich, Germany
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Xu J, Li H, Sze DMY, Chan VWS, Yang AWH. Effectiveness of qigong and tai chi in the quality of life of patients with cancer: protocol for an umbrella review. BMJ Open 2022; 12:e057980. [PMID: 35365537 PMCID: PMC8977801 DOI: 10.1136/bmjopen-2021-057980] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/30/2022] Open
Abstract
INTRODUCTION Qigong and tai chi (QTC) have been adopted by many patients with cancer as a complementary treatment with their conventional mainstream cancer management. Findings from current systematic reviews are inconsistent. Some research indicated that either qigong or tai chi interventions could enhance quality of life (QoL), and improve cancer-related symptoms such as fatigue, sleep disturbance and anxiety; while others argued that there was a lack of efficacy of QTC on QoL improvement. This umbrella review will analyse and synthesise the findings from published systematic reviews and meta-analyses regarding the effectiveness of QTC in the QoL of patients with cancer. Twenty-five databases will be searched from their respective inception to December 2021. METHODS AND ANALYSIS We will conduct a search in 21 English and 4 Chinese databases to identify qualified systematic reviews and meta-analyses. Two reviewers will independently screen all the titles and abstracts, and determine whether the article meets the inclusion criteria. After the identified systematic reviews and/or meta-analyses are confirmed, important information from each article will be extracted to the characteristics table by two reviewers independently. Two reviewers will independently analyse the quality of the selected reviews based on the Assessment of Multiple Systematic Reviews guideline. Findings from the systematic reviews and/or meta-analyses will be summarised and reported. ETHICS AND DISSEMINATION This review does not require ethics approval as the study is based on the published articles. The results drawn from the present review will be submitted to peer-reviewed journals for publication or presented at conferences. PROSPERO REGISTRATION NUMBER CRD42021253216.
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Affiliation(s)
- Jing Xu
- School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
| | - Hong Li
- Syndrome Laboratory of Integrated Chinese and Western Medicine, School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, Guangdong, China
- School of Science, RMIT University, Melbourne, Victoria, Australia
| | - Daniel Man-Yuen Sze
- School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
| | - Vincent Wan Shing Chan
- School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
| | - Angela Wei Hong Yang
- School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia
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A retrospective study on chemotherapy-induced nausea and vomiting in highly/moderately emetogenic chemotherapy: incidence and prescribing practice. Support Care Cancer 2022; 30:5339-5349. [PMID: 35290510 DOI: 10.1007/s00520-022-06956-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2021] [Accepted: 03/03/2022] [Indexed: 10/18/2022]
Abstract
BACKGROUND Chemotherapy-induced nausea vomiting (CINV) is a common and significant problem in oncology patients and rated as one of cancer chemotherapy's most distressing side effects. The objectives of this study are to describe the incidence of CINV in highly and moderately emetogenic chemotherapy-treated patients and the prescribing pattern of CINV prophylaxis. METHODS This retrospective, cross-sectional single-center study randomly collected data on demographics, CINV episodes, and prescribing patterns for adult oncology patients receiving intravenous highly or moderately emetogenic chemotherapy (HEC/MEC) between January and December 2019. RESULTS A total of 419 randomly selected records of HEC/MEC recipients with 2388 total chemotherapy cycles were included. The mean age was 53.6 ± 12.6 years old. The majority was female (66%), Malay (54.4%), diagnosed with cancer stage IV (47.7%), and with no comorbidities (47%). All patients were prescribed with IV granisetron and dexamethasone before chemotherapy for acute prevention, whereas dexamethasone and metoclopramide were prescribed for delayed prevention. Aprepitant was not routinely prescribed for the prevention of CINV. CINV incidence was 57% in the studied population and 20% in the total cycle. This study found a significant association between CINV incidence with performance status and cisplatin-based chemotherapy (OR = 3.071, CI = 1.515-6.223, p = 0.002; OR = 4.587, CI = 1.739-12.099, p = 0.02, respectively). CONCLUSION CINV incidence was rather high per patient but relatively low per cycle. Most patients were prescribed with dual regimen antiemetic prophylaxis. IMPACT This study provides evidence that there was suboptimal use of recommended agents for CINV, and there is a clear need for further improvements in CINV management.
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Chow R, Navari RM, Terry B, DeAngelis C, Prsic EH. Olanzapine 5 mg vs 10 mg for the prophylaxis of chemotherapy-induced nausea and vomiting: a network meta-analysis. Support Care Cancer 2022; 30:1015-1018. [PMID: 34613472 DOI: 10.1007/s00520-021-06606-x] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Affiliation(s)
- Ronald Chow
- Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
| | | | - Bryan Terry
- Yale New Haven Hospital, Yale School of Medicine, Yale University, New Haven, CT, USA
| | - Carlo DeAngelis
- Sunnybrook Health Sciences Centre, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada
| | - Elizabeth Horn Prsic
- Yale New Haven Hospital, Yale School of Medicine, Yale University, New Haven, CT, USA
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Mosa ASM, Rana MKZ, Islam H, Hossain AKMM, Yoo I. A Smartphone-Based Decision Support Tool for Predicting Patients at Risk of Chemotherapy-Induced Nausea and Vomiting: Retrospective Study on App Development Using Decision Tree Induction. JMIR Mhealth Uhealth 2021; 9:e27024. [PMID: 34860677 PMCID: PMC8686466 DOI: 10.2196/27024] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2021] [Revised: 03/11/2021] [Accepted: 08/04/2021] [Indexed: 11/13/2022] Open
Abstract
BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) are the two most frightful and unpleasant side effects of chemotherapy. CINV is accountable for poor treatment outcomes, treatment failure, or even death. It can affect patients' overall quality of life, leading to many social, economic, and clinical consequences. OBJECTIVE This study compared the performances of different data mining models for predicting the risk of CINV among the patients and developed a smartphone app for clinical decision support to recommend the risk of CINV at the point of care. METHODS Data were collected by retrospective record review from the electronic medical records used at the University of Missouri Ellis Fischel Cancer Center. Patients who received chemotherapy and standard antiemetics at the oncology outpatient service from June 1, 2010, to July 31, 2012, were included in the study. There were six independent data sets of patients based on emetogenicity (low, moderate, and high) and two phases of CINV (acute and delayed). A total of 14 risk factors of CINV were chosen for data mining. For our study, we used five popular data mining algorithms: (1) naive Bayes algorithm, (2) logistic regression classifier, (3) neural network, (4) support vector machine (using sequential minimal optimization), and (5) decision tree. Performance measures, such as accuracy, sensitivity, and specificity with 10-fold cross-validation, were used for model comparisons. A smartphone app called CINV Risk Prediction Application was developed using the ResearchKit in iOS utilizing the decision tree algorithm, which conforms to the criteria of explainable, usable, and actionable artificial intelligence. The app was created using both the bulk questionnaire approach and the adaptive approach. RESULTS The decision tree performed well in both phases of high emetogenic chemotherapies, with a significant margin compared to the other algorithms. The accuracy measure for the six patient groups ranged from 79.3% to 94.8%. The app was developed using the results from the decision tree because of its consistent performance and simple, explainable nature. The bulk questionnaire approach asks 14 questions in the smartphone app, while the adaptive approach can determine questions based on the previous questions' answers. The adaptive approach saves time and can be beneficial when used at the point of care. CONCLUSIONS This study solved a real clinical problem, and the solution can be used for personalized and precise evidence-based CINV management, leading to a better life quality for patients and reduced health care costs.
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Affiliation(s)
- Abu Saleh Mohammad Mosa
- Health Management and Informatics, University of Missouri School of Medicine, Columbia, MO, United States
- Institute for Data Science and Informatics, University of Missouri, Columbia, MO, United States
- Electrical Engineering and Computer Science, University of Missouri, Columbia, MO, United States
- Center for Biomedical Informatics, University of Missouri School of Medicine, Columbia, MO, United States
| | - Md Kamruz Zaman Rana
- Health Management and Informatics, University of Missouri School of Medicine, Columbia, MO, United States
- Institute for Data Science and Informatics, University of Missouri, Columbia, MO, United States
| | - Humayera Islam
- Institute for Data Science and Informatics, University of Missouri, Columbia, MO, United States
- Center for Biomedical Informatics, University of Missouri School of Medicine, Columbia, MO, United States
- Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh
| | - A K M Mosharraf Hossain
- Ellis Fischel Cancer Center, University of Missouri School of Medicine, Columbia, MO, United States
- Department of Hematology and Medical Oncology, BayCare Health System, South Florida Baptist Hospital, Plant City, FL, United States
| | - Illhoi Yoo
- Health Management and Informatics, University of Missouri School of Medicine, Columbia, MO, United States
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Yeo W, Mo FK, Yip CC, Yeo VA, Li L, Lau TK, Lai KT, Chan VT, Wong KH, Pang E, Cheung M, Chan V, Kwok CC, Suen JJ, Molassiotis A. Quality of Life Associated with Nausea and Vomiting from Anthracycline-Based Chemotherapy: A Pooled Data Analysis from Three Prospective Trials. Oncologist 2021; 26:e2288-e2296. [PMID: 34516038 PMCID: PMC8648999 DOI: 10.1002/onco.13978] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2021] [Accepted: 08/20/2021] [Indexed: 11/08/2022] Open
Abstract
BACKGROUND There is limited work on the impact of chemotherapy-induced nausea and vomiting (CINV) on quality of life (QoL) in adriamycin-cyclophosphamide (AC)-treated patients with breast cancer. The objectives of the study were the following: (a) to confirm if symptoms of CINV led to lower QoL during AC; (b) to evaluate the pattern of changes in patients' QoL during multiple cycles of AC; and (c) to assess if the QoL in an earlier cycle affected the QoL in subsequent cycles of AC. MATERIALS AND METHODS This is a secondary pooled data analysis that included 303 Chinese patients with breast cancer who received 1,177 cycles of adjuvant AC in three prospective antiemetic studies. QoL data were based on Functional Living Index-emesis (FLIE) scored over three to four AC cycles. CINV symptoms assessed included "no significant nausea" (NSN), "significant nausea" (SN), "no vomiting" (NoV), "vomiting" (V), and complete response (CR). RESULTS Across all AC cycles, the mean scores for the FLIE nausea domain for patients who experienced NSN versus SN were 10.92 versus 53.92, respectively (p < .0001), with lower scores indicating better QoL; the mean scores for the FLIE vomiting domain for patients who experienced NoV versus V were 1.44 versus 19.11, respectively (p < .0001), with similar results across subsequent cycles. Analysis of the effect of the QoL in cycle 1 on the QoL of subsequent cycles revealed the following: for the nausea domain, among patients who had cycle 1 FLIE scores ≥ versus < the mean, the corresponding scores in cycle 2 were 6.87 versus 36.71 (p < .0001); whereas those for cycle 3 were 7.07 versus 36.87 (p < .0001); and those for cycle 4 were 5.92 versus 21.48 (p < .0001). Similar findings were observed for the vomiting domain. Netupitant + palonosetron- or aprepitant/olanzapine-based antiemetics had significantly better QoL outcomes. CONCLUSION CINV had a significant impact on the QoL of patients with breast cancer treated with AC over multiple cycles. IMPLICATIONS FOR PRACTICE In this post-hoc analysis of three prospective studies on chemotherapy-induced nausea and vomiting (CINV), quality of life (QoL) using contemporary antiemetic regimens in Chinese breast cancer patients receiving doxorubicin-cyclophosphamide (AC) was evaluated. During the first and subsequent AC cycles, QoL was significantly better for patients who did not experience vomiting or significant nausea. QoL in an earlier cycle affected the QoL in subsequent AC cycles. Furthermore, recent regimens involving olanzapine/aprepitant or netupitant-palonosetron were associated with a positive impact in QoL. Antiemetic guideline-consistent practice and higher clinician awareness of the impact of CINV on QoL can further mitigate the negative effects of CINV on QoL.
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Affiliation(s)
- Winnie Yeo
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
- State Key Laboratory of Translational Oncology, The Chinese University of Hong KongHong Kong SAR
| | - Frankie K.F. Mo
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
- State Key Laboratory of Translational Oncology, The Chinese University of Hong KongHong Kong SAR
| | - Christopher C.H. Yip
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Victoria A. Yeo
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Leung Li
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Thomas K.H. Lau
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Kwai T. Lai
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Vicky T.C. Chan
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Kwan H. Wong
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Elizabeth Pang
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Maggie Cheung
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Vivian Chan
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Carol C.H. Kwok
- Department of Clinical Oncology, Princess Margaret HospitalKowloonHong Kong
| | - Joyce J.S. Suen
- Department of Clinical Oncology, Prince of Wales Hospital, Faculty of Medicine, Hong Kong Cancer InstituteHong Kong
| | - Alex Molassiotis
- School of Nursing, The Hong Kong Polytechnic UniversityHong Kong
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LI X, ZHAO C, SHI JF. Acupoint selection rules in treatment of chemotherapy-induced nausea and vomiting with acupuncture and moxibustion针灸治疗化疗后恶心呕吐取穴规律的文献研究. WORLD JOURNAL OF ACUPUNCTURE-MOXIBUSTION 2021. [DOI: 10.1016/j.wjam.2021.12.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
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Kamiya T, Sakurai M, Kikuchi T, Okayama M, Mizuno K, Tanigawa T, Koda Y, Kato J, Mori T. Efficacy of ondansetron against emesis induced by a multiple-day cisplatin-based chemotherapy regimen for malignant lymphoma. Hematology 2021; 26:945-949. [PMID: 34789076 DOI: 10.1080/16078454.2021.2001150] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022] Open
Abstract
OBJECTIVES This study aimed to evaluate the antiemetic efficacy of a 5-hydroxytryptamine-3 receptor antagonist (5-HT3RA), ondansetron, in patients with malignant lymphoma receiving multi-day cisplatin-based combination chemotherapy. METHODS We conducted a single-institution retrospective analysis of patients receiving the first course of an ESHAP (etoposide, cisplatin, methylprednisolone, cytarabine) regimen including 4-day continuous infusion of cisplatin (25 mg/m2/day). All patients received ondansetron 4 mg intravenously during 5-day administration of ESHAP. The primary endpoint was complete response (CR) for emesis, which was defined as absence of both emesis and rescue medications. Total control (TC) was defined as an absence of emetic episodes, including nausea and emesis, and complete protection (CP) was defined as an absence of emesis with addition of rescue antiemetics. Nausea and vomiting were assessed and graded daily by medical staff. RESULTS Eighty-two patients were analyzed. Nausea and vomiting were generally well controlled, with the CR rates of emesis being 79% in the overall phase, 82% in the early phase (days 1-6), and 89% in the delayed phase (days 7-10). TC and CP were achieved in 51 patients (62%) and 77 patients (94%) in the overall phase. DISCUSSION Most of the chemotherapy regimens for lymphoid malignancies include high-dose corticosteroid which may be also effective as antiemetics. Although NK1 receptor antagonist (NK1RA) is generally recommended for cisplatin-containing chemotherapy, it can interact with variety drugs. CONCLUSION Although NK1RA is generally recommended for cisplatin-containing regimen, our results suggest that ondansetron effectively controlled emesis in patients receiving ESHAP therapy which includes high-dose corticosteroid.
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Affiliation(s)
- Takahiro Kamiya
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Masatoshi Sakurai
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Taku Kikuchi
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Mikio Okayama
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Kota Mizuno
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Tomohiko Tanigawa
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Yuya Koda
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Jun Kato
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Takehiko Mori
- Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan
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Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer 2021; 7:e25648. [PMID: 34738909 PMCID: PMC8663669 DOI: 10.2196/25648] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2020] [Revised: 06/14/2021] [Accepted: 09/25/2021] [Indexed: 11/30/2022] Open
Abstract
Background Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer. Objective The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem. Methods This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy. Results The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively). Conclusions This study’s results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients’ desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial. Trial Registration ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180 International Registered Report Identifier (IRRID) RR2-10.2196/17232
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Affiliation(s)
- Audrey Murat-Ringot
- Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.,INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France.,Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France
| | | | - Fabien Subtil
- Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France.,Biometrics and Evolutionary Biology UMR 5558, Claude Bernard University I, Centre national de la recherche scientifique, Villeurbanne, France
| | - Florent Boutitie
- Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France
| | - Marie Preau
- Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France
| | - Vincent Piriou
- Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.,INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France
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Wazqar DY, Thabet HA, Safwat AM. A Quasi-Experimental Study of the Effect of Ginger Tea on Preventing Nausea and Vomiting in Patients With Gynecological Cancers Receiving Cisplatin-Based Regimens. Cancer Nurs 2021; 44:E513-E519. [PMID: 33867429 DOI: 10.1097/ncc.0000000000000939] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
BACKGROUND Cancer patients receiving chemotherapy experience acute and delayed nausea and vomiting. These side effects obligate the patients to use pharmacological and nonpharmacological methods. The effect of ginger tea as an antiemetic modality on preventing chemotherapy-related nausea and vomiting has not been confirmed in previous studies. OBJECTIVE The aim of this study was to assess the effect of ginger tea, when given together with the standard antiemetic regimen, on preventing nausea and vomiting in patients with gynecological cancers receiving cisplatin-based regimens. METHODS This study used a quasi-experimental research design with 2 groups (control and intervention groups, 50 participants each). A sociodemographic and medical survey and the Modified Rhodes Index of Nausea, Vomiting, and Retching were used to collect the data. Descriptive analyses, t test, and χ2 test were used to analyze the data. RESULTS The total mean Modified Rhodes Index of Nausea, Vomiting, and Retching scores were lower in the intervention group in all measurements compared with the control group, and the differences between the total mean scores for symptom experience, development, and distress between the groups were statistically significant in the third (P < .05), fourth (P < .01), and fifth (P < .05) measurements. No ginger-related side effects were noted in this study. CONCLUSIONS Ginger tea reduced the experience, development, and distress of nausea, vomiting, and retching in the intervention group. The use of ginger tea may be recommended for chemotherapy-associated nausea and vomiting in cancer patients receiving cisplatin-based regimens. IMPLICATIONS FOR PRACTICE Oncology nurses can lead the implementation of ginger tea intervention to prevent chemotherapy-related nausea and vomiting.
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Affiliation(s)
- Dhuha Y Wazqar
- Author Affiliations: Department of Medical Surgical Nursing, Faculty of Nursing, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia (Dr Wazqar); Department of Woman's Health and Midwifery Nursing, Faculty of Nursing, Mansoura University, Mansoura, Egypt (Dr Thabet); and Department of Medical Surgical Nursing, Faculty of Nursing, Ain Shams University, Cairo, Egypt (Dr Safwat)
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Kamal SM, Elhusseini NM, Sedik MF, Mohamad MF, Khedr EM, Kotb HI. Effect of transcranial direct current brain stimulation of the motor cortex on chemotherapy induced nausea and vomiting in female patients with breast cancer. PAIN MEDICINE 2021; 23:571-578. [PMID: 34677609 DOI: 10.1093/pm/pnab313] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/23/2020] [Revised: 08/17/2021] [Accepted: 09/02/2021] [Indexed: 11/13/2022]
Abstract
OBJECTIVE Chemotherapy-induced nausea and vomiting (CINV) is a negative impact associated to chemotherapy and its management still challenging. This study aimed to research the additive impact of single-session tDCS (2 mA) over the motor cortex for 20 minutes before chemotherapy to antiemetic on CINV in female patients suffers from breast cancer who obtained highly emetogenic chemotherapy. STUDY LAYOUT Prospective randomized double-blind Sham-controlled study. SETTING Academic medical center. METHOD Sixty breast cancer patients prepared for chemotherapy treatment were selected and allocated randomly into two equal groups: a real and a sham group; tDCS became implemented over the primary motor area (M1) (2 mA) for 20 minutes. Patients' nausea was measured by cumulative index of nausea and visual analog scale for nausea (VAS-N), and vomiting by cumulative index of episodes of vomiting, and Edmonton symptoms Assessment Scale (ESAS) to assess symptoms like pain, malaise, and sense of well-being. Evaluation was done prestimulation and every 24 h for 72 h after end of infusion of chemotherapy. RESULTS Real tDCS group showed reduction of cumulative index of nausea (P < 0.001, F = 50), VAS-N (P < 0.001, F = 52) and for ESAS in malaise score (P < 0.001, F = 37.6) and sense of wellbeing score (P < 0.001, F = 25) than sham group. Six patients (20%) in the real group required rescue antiemtic therapy vs. 14 patients (46.7%) in the Sham group (P < 0.028). CONCLUSION Single session of real M1 tDCS could be suggested as an effective adjuvant maneuver in control of CINV in female patients suffers from breast cancer who obtained highly emetogenic chemotherapy. TRIAL REGISTRATION Clinical Trials.gov trial registry (identifier: NCT03405324).
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Affiliation(s)
- S M Kamal
- Associate professor in Anesthesia, intensive care and pain management department, South Egypt Cancer institute, Assiut University, Assiut, Egypt
| | - N M Elhusseini
- Resident of anesthesiology, intensive care and pain management, South Egypt Cancer institute, Assiut University, Assiut, Egypt
| | - M F Sedik
- Lecturer in medical oncology department, South Egypt Cancer institute, Assiut University, Assiut, Egypt
| | - M F Mohamad
- Associate professor in Anesthesia, intensive care and pain management department, South Egypt Cancer institute, Assiut University, Assiut, Egypt
| | - E M Khedr
- Professor of neurology and psychiatry, faculty of medicine, Assiut University, Assiut, Egypt
| | - H I Kotb
- Professor of anesthesiology, intensive care and pain management, Faculty of medicine, Assiut University, Assiut, Egypt
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Xi S, Zhai X, Wang Y, Gong Y, Fu B, Gao C, Guo X, Li Y, Wang Z, Huang S, Lu D, Zhao Y, Qian L, Wang Y. The Ciji-Hua'ai-Baosheng II Formula Attenuates Chemotherapy-Induced Anorexia in Mice With H 22 Hepatocellular Carcinoma. Front Pharmacol 2021; 12:715824. [PMID: 34489705 PMCID: PMC8416666 DOI: 10.3389/fphar.2021.715824] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Accepted: 07/21/2021] [Indexed: 01/04/2023] Open
Abstract
Background: Ciji-Hua’ai-Baosheng II Formula (CHB-II-F) is a traditional Chinese medicine formula, which specifically targets different aspects of chemotherapy-induced adverse effects in patients with cancer. In our clinical application, CHB-II-F significantly alleviated chemotherapy-induced anorexia (loss of appetite) and improved the quality of life for patients with tumor during and after chemotherapy. However, the mechanism of CHB-II-F in alleviation of chemotherapy-induced anorexia remains to be further investigated. Aim of Study: To explore the therapeutic effect and mechanism of CHB-II-F on chemotherapy-induced anorexia in the mice model of H22 hepatoma. Materials and Methods: A total of 72 Kunming mice of SPF grade were inoculated subcutaneously with H22 hepatoma cells into the right anterior armpit of the mice. After 1 week of seeding, mice were injected intraperitoneally with a high dose of 5-fluorouracil (200 mg/kg 5-FU) to establish the model of chemotherapy. The mice were randomly divided into six groups: untreated group, 5-FU group, 5-FU plus Yangzheng Xiaoji capsule (YZXJC) group, and three groups of 5-FU plus different concentrations of CHB-II-F. All the mice in each group were treated for 14 days. The body weight, food intake, tumor volume, and tumor weight of mice were measured, and pathological examinations of tumor tissue, stomach, and duodenum were carried out. Expressions of serum Leptin, Neuropeptide Y (NPY), epidermal cell growth factor (EGF), Motilin (MTL), Orexin A (OXA), Gastrin (GAS), Ghrelin, Prostaglandin E2 (PGE2), and jejunum superoxide dismutase (SOD) activity and malondialdehyde (MDA) content were examined. The protein and mRNA levels of proopiomelanocortin (POMC), Orexin receptor 1 (OX1R), neuropeptide Y (NPY), cocaine and amphetamine regulated transcript peptide (CART), Agouti gene-related protein (AgRP), Leptin receptor (Ob-R), and Ghrelin receptor (GHSR) were examined in hypothalamus, and the protein levels of substance P (SP) and 5-hydroxytryptamine (5-HT) in duodenum were measured. Results: The combination of CHB-II-F and 5-FU could enhance the inhibitory effect of 5-FU on tumor. The tumor inhibition rates of 5-FU group, YZXJC group, CHB-II-F(H) group, CHB-II-F(M) group, and CHB-II-F(L) group were 58.88, 28.08, 54.96, 37.69, and 28.61%, respectively. Compared with untreated group and 5-FU group, CHB-II-F significantly increased the body weight and food intake of tumor-bearing mice; increased the content of NPY, Orexin A, Ghrelin, GAS, MTL, EGF, and PGE2 in serum and the activity of SOD in jejunum; and decreased the content of Leptin in serum and the content of MDA in jejunum. Compared with untreated group and 5-FU group, CHB-II-F also enhanced the expression of OX1R, GHSR, NPY, and AgRP protein and gene and decreased the expression of Ob-R, POMC, and CART protein and gene in hypothalamus of mice, and the gene expression was consistent with the protein expression. In addition, CHB-II-F decreased the expression of 5-HT and SP protein in duodenum. Conclusion: In the murine model of H22 hepatocellular carcinoma (HCC) receiving chemotherapy, CHB-II-F enhances the inhibitory effect of 5-FU on tumor, significantly improves the pathological injury of gastrointestinal tract caused by chemotherapy, and regulates the secretion of gastrointestinal hormones. It may alleviate chemotherapy-induced anorexia by affecting appetite regulatory factors in the feeding area of hypothalamus central nervous system and peripheral appetite regulatory factors.
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Affiliation(s)
- Shengyan Xi
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China.,Department of Traditional Chinese Medicine, Xiang'an Hospital of Xiamen University, Xiamen, China
| | - Xiangyang Zhai
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Yanan Wang
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Yuewen Gong
- College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada
| | - Biqian Fu
- The First School of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China
| | - Chunling Gao
- Department of Radiotherapy, Chenggong Hospital of Xiamen University, Xiamen, China
| | - Xuehui Guo
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Yunhong Li
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Zheng Wang
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Shuqiong Huang
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Dawei Lu
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Yufang Zhao
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China
| | - Linchao Qian
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China.,Department of Traditional Chinese Medicine, Xiang'an Hospital of Xiamen University, Xiamen, China
| | - Yanhui Wang
- Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China.,Department of Traditional Chinese Medicine, Xiang'an Hospital of Xiamen University, Xiamen, China
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Fernando GC, Kondasinghe JS. Mechanistic approach to the management of cancer-related nausea and vomiting in a palliative care resource-limited setting. Int J Palliat Nurs 2021; 27:362-366. [PMID: 34569286 DOI: 10.12968/ijpn.2021.27.7.362] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
BACKGROUND Nausea and vomiting are two interrelated distressing symptoms experienced by patients with malignancies. They are multifactorial in aetiology. CASE PRESENTATION A middle-aged woman diagnosed with bilateral ovarian malignancy had undergone chemotherapy and was suffering nausea and vomiting, and was responding to basic therapeutic measures. CASE MANAGEMENT She was resistant to treatment with metoclopramide that was commenced by the oncology team, as for any patient with nausea and vomiting. This report examines a 'mechanistic' approach to nausea management and life-style modifications. CASE OUTCOME Within 2 days of the evidence-based revision of her management plan, the patient expressed that she had experienced a significant symptomatic relief and an improvement in her general wellbeing. CONCLUSION The early identification of the most probable causative factors of nausea and vomiting in patients with advanced malignancies will lead to significant improvements in their quality of life and save time and resources.
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Affiliation(s)
- Gvm Chamath Fernando
- Lecturer/Family Physician, Department of Family Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka
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Moshayedi M, Salehifar E, Karami H, Hendouei N, Mousazadeh M, Alizadeh Haji S. Efficacy and Safety of Adding Olanzapine to the Standard Preventive Regimen for Chemotherapy-induced Nausea and Vomiting in Children: A Randomized Double-blind Controlled Trial. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH : IJPR 2021; 20:318-326. [PMID: 34400961 PMCID: PMC8170772 DOI: 10.22037/ijpr.2019.112514.13803] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
This study aimed to assess the additive value of olanzapine to a combination of ondansetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in pediatric patients. A total of 40 patients between 4 to 18 years of age were enrolled in this randomized clinical trial. Both groups received a combination of ondansetron and dexamethasone, and 0.14 mg/kg olanzapine or matched placebo were administered for olanzapine and control groups, respectively. The primary end points were complete response and lack of nausea as far as three days after chemotherapy evaluated by the Common Terminology Criteria for Adverse Effects (CTCAE) v5.0 and the Multinational Association of Supportive Care in Cancer (MASCC) Anti-emesis Tool (MAT). Side effects of olanzapine were also analyzed. In patients receiving the standard regimen of ondansetron and dexamethasone, nausea was observed in 10.5% and 21% of patients according to MAT and CTCAE scales, respectively. In the olanzapine group, 37.5% (MAT scale) and 31.3% (CTCAE scale) of patients developed nausea. Complete response was observed in 84% (MAT scale) and 94.7% (CTCAE scale) of patients in the placebo group receiving ondansetron and dexamethasone. In comparison, it was observed in 87.5% (MAT scale) and 81.25% (CTCAE scale) for patients allocated to the olanzapine group. Neither acute nor delayed CINV was statistically different between placebo and olanzapine groups. The frequency of adverse effects was higher in the olanzapine group. Adding olanzapine to the standard regimen of CINV prophylaxis was only unhelpful in pediatric patients receiving moderately emetogenic chemotherapy but also associated with a higher rate of minor side effects.
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Affiliation(s)
- Mona Moshayedi
- Student Research Committee, Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - Ebrahim Salehifar
- Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
| | - Hossein Karami
- Thalassemia Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| | - Narjes Hendouei
- Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
| | - Mahmoud Mousazadeh
- Health Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - Somaye Alizadeh Haji
- Thalassemia Research Center, Mazandaran University of Medical Sciences, Sari, Iran
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49
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Zhou JG, Huang L, Jin SH, Xu C, Frey B, Ma H, Gaipl US. Olanzapine combined with 5-hydroxytryptamine type 3 receptor antagonist (5-HT3 RA) plus dexamethasone for prevention and treatment of chemotherapy-induced nausea and vomiting in high and moderate emetogenic chemotherapy: a systematic review and meta-analysis of randomised controlled trials. ESMO Open 2021; 5:S2059-7029(20)30018-1. [PMID: 32079622 PMCID: PMC7046384 DOI: 10.1136/esmoopen-2019-000621] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2019] [Revised: 12/03/2019] [Accepted: 12/29/2019] [Indexed: 01/30/2023] Open
Abstract
We performed a pooled analysis to evaluate the efficacy and adverse events (AEs) of olanzapine combined with dexamethasone plus 5-hydroxytryptamine type 3 receptor antagonist (5-HT3 RA) compared with 5-HT3 RA plus dexamethasone for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV) in high and moderate emetogenic chemotherapy based on randomised controlled trials (RCTs). PubMed, EMBASE, Web of Science, the Cochrane Library, China Biomedical Literature database (CBM), WanFang Database, China National Knowledge Infrastructure (CNKI), and Chinese Science and Technology Periodical Database (VIP) (from their inception to April 2019) were searched to capture relevant articles. Relative risk with 95% confidence intervals for CINV and AEs were all extracted or calculated. Eleven studies with 1107 cancer patients were involved in this review. The pooled RR of delayed CINV (RR 0.50, 95% CI 0.38 to 0.66; p<0.01) were significantly decreased in the olanzapine group. The occurrence of insomnia was also statistically decreased, as was the rate of acute CINV (RR 0.60, 95% CI 0.48 to 0.75; p<0.01). However, only the percentages of CINV III and CINV IV were significantly decreased in the acute and delayed phases. Subgroup analysis demonstrated that the efficacy was not statistically significantly different between 5 mg and 10 mg olanzapine. Olanzapine significantly decreased the occurrence of CINV III and IV and insomnia in high and moderately emetogenic chemotherapy. Compared with 10 mg per day, 5 mg oral olanzapine may be more appropriate for patients with cancer.
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Affiliation(s)
- Jian-Guo Zhou
- Department of Oncology, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, China.,Department of Radiation Oncology, Universitätsklinikum Erlangen, Erlangen, Germany
| | - Lang Huang
- Department of Oncology, Guangyuan Central Hospital, Guangyuan, China
| | - Su-Han Jin
- Department of Orthodontics, Affiliated Stomatological Hospital of Zunyi Medical University, Zunyi, China
| | - Cheng Xu
- Department of Oncology, Guangyuan Central Hospital, Guangyuan, China
| | - Benjamin Frey
- Department of Radiation Oncology, Universitätsklinikum Erlangen, Erlangen, Germany
| | - Hu Ma
- Department of Oncology, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, China
| | - Udo S Gaipl
- Department of Radiation Oncology, Universitätsklinikum Erlangen, Erlangen, Germany
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50
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Patel P, Robinson PD, Devine KA, Positano K, Cohen M, Gibson P, Holdsworth M, Phillips R, Spinelli D, Thackray J, van de Wetering M, Woods D, Cabral S, Sung L, Dupuis LL. Prevention and treatment of anticipatory chemotherapy-induced nausea and vomiting in pediatric cancer patients and hematopoietic stem cell recipients: Clinical practice guideline update. Pediatr Blood Cancer 2021; 68:e28947. [PMID: 33686754 DOI: 10.1002/pbc.28947] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2020] [Revised: 01/20/2021] [Accepted: 01/22/2021] [Indexed: 12/20/2022]
Abstract
This 2021 clinical practice guideline update provides recommendations for preventing anticipatory chemotherapy-induced nausea and vomiting (CINV) in pediatric patients. Recommendations are based on systematic reviews that identified (1) if a history of acute or delayed CINV is a risk factor for anticipatory CINV, and (2) interventions for anticipatory CINV prevention and treatment. A strong recommendation to optimize acute and delayed CINV control in order to prevent anticipatory CINV is made. Conditional recommendations are made for hypnosis, systematic desensitization, relaxation techniques, and lorazepam for the secondary prevention of anticipatory CINV. No recommendation for the treatment of anticipatory CINV can be made.
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Affiliation(s)
- Priya Patel
- Pediatric Oncology Group of Ontario, Toronto, Ontario, Canada
| | | | - Katie A Devine
- Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA
| | - Karyn Positano
- Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada
| | | | - Paul Gibson
- Pediatric Oncology Group of Ontario, Toronto, Ontario, Canada.,Division of Haematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada
| | - Mark Holdsworth
- College of Pharmacy, University of New Mexico, Albuquerque, New Mexico, USA
| | - Robert Phillips
- Department of Haematology and Oncology, Leeds Teaching Hospital, NHS Trust, Leeds, UK
| | - Daniela Spinelli
- Patient Representative.,Department of Pharmacy, Memorial Sloan Kettering Cancer Center, New York, New York, USA
| | - Jennifer Thackray
- Department of Pharmacy, Memorial Sloan Kettering Cancer Center, New York, New York, USA
| | | | - Deborah Woods
- University of California, Davis Health, Pediatric Hematology/Oncology, Davis, California, USA
| | - Sandra Cabral
- Pediatric Oncology Group of Ontario, Toronto, Ontario, Canada
| | - Lillian Sung
- Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.,Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - L Lee Dupuis
- Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada.,Department of Pharmacy, The Hospital for Sick Children, Toronto, Ontario, Canada.,Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
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