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Zhang K, Wang Q, Cao J, Fan C, Shen W, Xiao Q, Ge X, Zhang T, Liu X, Chen X, Dong J, Li Z, Zheng Z, Yan C, Wang P, Pang Q, Zhang W. Tislelizumab plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy for elderly patients with inoperable locally advanced esophageal squamous cell carcinoma: a multicenter, randomized, parallel-controlled, phase II clinical trial. BMC Cancer 2025; 25:347. [PMID: 40001034 PMCID: PMC11863415 DOI: 10.1186/s12885-025-13758-0] [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: 02/20/2024] [Accepted: 02/17/2025] [Indexed: 02/27/2025] Open
Abstract
BACKGROUND The standard treatment for elderly patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is definitive chemoradiotherapy with S-1. However, the 3-year overall survival (OS) is limited to approximately 40%. Tislelizumab is the first- and second-line standard treatment for advanced ESCC with tolerable toxicity. In this study, we aimed to explore a new curative strategy for locally advanced unresectable ESCC in the elderly by combining tislelizumab with chemoradiotherapy. METHODS This study is an open-label, multicenter, investigator-initiated phase II clinical trial in older patients with inoperable locally advanced ESCC evaluating tislelizumab plus concurrent chemoradiotherapy compared with concurrent chemoradiotherapy. The main inclusion criteria were pathological confirmation of locally advanced inoperable ESCC at clinical cT1N2-3M0 or cT2-4bN0-3M0 (stage II-IVA), age ≥ 70 years, absence of previous systemic anti-tumor therapy, and adequate organ function. A total of 136 patients will be recruited from approximately seven centers (in Tianjin, Chengdu, Taiyuan, Zhengzhou, Shijiazhuang, Changsha, Nanjing) over a period of 18 months and randomized in a 1:1 ratio to receive tislelizumab in combination with concurrent chemoradiotherapy (tislelizumab + S-1 + radiotherapy) or concurrent chemoradiotherapy (S-1 + radiotherapy). The efficacy and safety of the treatment will be evaluated during the therapy and follow-up period until disease progression, death, or the end of the trial. The primary study endpoint was investigator-assessed progression-free survival (PFS), and secondary study endpoints were OS, objective response rate (ORR), duration of remission (DOR), and safety. Fresh or archival tumor tissues and peripheral blood samples will be used in exploratory studies. DISCUSSION This study is the first "programmed death-1 (PD-1) inhibitor combined with concurrent chemoradiotherapy" for elderly patients with inoperable locally advanced ESCC (NCT06061146). The synergistic efficacy of combined definitive concurrent chemoradiotherapy with tislelizumab is expected to result in survival benefits for elderly patients with inoperable locally advanced ESCC. Because S-1 plus concurrent radiotherapy is the standard treatment option for locally advanced ESCC in older patients, the combination of definitive concurrent chemoradiotherapy and tislelizumab has the potential to change the standard ESCC therapeutic strategy with comparable safety. TRIAL REGISTRATION ClinicalTrials.gov NCT06061146.Registered 9/10/2023.
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Affiliation(s)
- Ke Zhang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Qifeng Wang
- Radiation Oncology Key Laboratory of Sichuan Province, Department of Radiation Oncology, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
| | - Jianzhong Cao
- Department of Radiotherapy, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, 030013, China
| | - Chengcheng Fan
- Department of radiation oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, Henan, China
| | - Wenbin Shen
- Radiotherapy Department of the Fourth Hospital of Hebei Medical University, Shijiazhuang, China
| | - Qin Xiao
- Thoracic Radiotherapy Department Hunan Cancer Hospital the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China
| | - Xiaolin Ge
- Department of Radiation Oncology, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, 300, Guangzhou Road, Nanjing, Jiangsu, China
| | - Tian Zhang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Xiao Liu
- Department of radiation oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, Henan, China
| | - Xi Chen
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Jie Dong
- Department of Nutrition Therapy, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Immunology and Biotherapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Zewei Li
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Zhunhao Zheng
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Cihui Yan
- Department of Immunology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Immunology and Biotherapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Ping Wang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Qingsong Pang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China
| | - Wencheng Zhang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huanhuxi Road, Hexi District, Tianjin, 300060, China.
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Gu D, Wang T, Guo Y, Liu Y, Fang Y, Chen W, Wang Q, Zhang R, Shi H, Wu D, Zhang Z, Zhou G, Ye J. Radiotherapy with S-1 for the treatment of esophageal squamous cell carcinoma 75 years or older. Radiat Oncol 2024; 19:112. [PMID: 39210445 PMCID: PMC11360844 DOI: 10.1186/s13014-024-02509-3] [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: 01/21/2024] [Accepted: 08/19/2024] [Indexed: 09/04/2024] Open
Abstract
OBJECTIVE Explore the efficacy and safety of involved-field irradiation (IFI) combined with S-1 as definitive concurrent chemoradiotherapy (dCRT) for locally advanced elderly esophageal squamous cell carcinoma (ESCC), under the premise of intensity-modulated radiotherapy (IMRT). METHODS We designed a prospective single-arm phase II study. The study enrolled 91 patients aged 75 to 92 years. Eligible participants had histologically confirmed squamous cell carcinoma, stage II to IV disease based on the 8th edition of the American Joint Committee on Cancer (AJCC). All elderly patients (EPs) received dCRT with S-1. which was administered orally twice daily for 28 days. The radiotherapy dose was 61.2 Gy delivered in 34 fractions or 50.4 Gy delivered in 28 fractions. The primary endpoint was 2-year overall survival (OS), and the secondary endpoints were progression-free survival (PFS), local control rate (LCR), and safety. RESULTS From July 2017 to July 2021, we enrolled EPs with ESCC who were treated at the Jiangsu Cancer hospital. As of August 1, 2023, the median follow-up of surviving EPs was 31.4 months (IQR: 25.2 to 72.6 months). 83 patients (91.2%) completed the whole course of treatment. The 2-year OS rate was 59.2%, and the PFS rate was 43.7%. The most common grade 1 to 2 adverse effects (AEs) were radiation esophagitis (79.1%), and then were radiation pneumonia (46.2%). Anemia (41.8%) was the most common of grade 1 to 2 hematologic toxicity. The incidence of grade 3 or above AEs was 24.2%, and the incidence of leukopenia was the highest (11.0%). There was not one death due to treatment-related toxicity. In a subgroup analysis of radiotherapy doses, we found no statistically significant differences in PFS (P = 0.465) and OS (P = 0.345) in EPs with ESCC who received 50.4 Gy and 61.2 Gy, and that patients in the 50.4 Gy group had lower dermatitis (P = 0.045) and anemia (P = 0.004). CONCLUSIONS IF-IMRT combined with S-1 is a promising regimen for elderly ESCC. And the radiotherapy dose of 50.4 Gy remains the standard dose for EPs with ESCC undergoing CCRT.
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Affiliation(s)
- Dayong Gu
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Tian Wang
- Xuzhou Cancer Hospital, Xuzhou, China
| | - Yiyu Guo
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Ying Liu
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Ying Fang
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Wei Chen
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Qiang Wang
- Jiangyan Hospital, Nanjing University of Chinese Medicine, Jiangyan, China
| | - Rongrong Zhang
- Jiangyan Hospital, Nanjing University of Chinese Medicine, Jiangyan, China
| | - Haifeng Shi
- Sheyang County People's Hospital, Yancheng, China
| | - Daguang Wu
- Funing County People's Hospital, Yancheng, China
| | - Zhi Zhang
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Guoren Zhou
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China
| | - Jinjun Ye
- Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baizitng, Xuanwu District, Nanjing, 210009, China.
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Huang Y, Huang X, Wang A, Chen Q, Chen G, Ye J, Wang Y, Qin Z, Xu K. Individualized treatment decision model for inoperable elderly esophageal squamous cell carcinoma based on multi-modal data fusion. BMC Med Inform Decis Mak 2023; 23:237. [PMID: 37872517 PMCID: PMC10594800 DOI: 10.1186/s12911-023-02339-5] [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: 07/13/2023] [Accepted: 10/15/2023] [Indexed: 10/25/2023] Open
Abstract
BACKGROUND This research aimed to develop a model for individualized treatment decision-making in inoperable elderly patients with esophageal squamous cell carcinoma (ESCC) using machine learning methods and multi-modal data. METHODS A total of 189 inoperable elderly ESCC patients aged 65 or older who underwent concurrent chemoradiotherapy (CCRT) or radiotherapy (RT) were included. Multi-task learning models were created using machine learning techniques to analyze multi-modal data, including pre-treatment CT images, clinical information, and blood test results. Nomograms were constructed to predict the objective response rate (ORR) and progression-free survival (PFS) for different treatment strategies. Optimal treatment plans were recommended based on the nomograms. Patients were stratified into high-risk and low-risk groups using the nomograms, and survival analysis was performed using Kaplan-Meier curves. RESULTS The identified risk factors influencing ORR were histologic grade (HG), T stage and three radiomic features including original shape elongation, first-order skewness and original shape flatness, while risk factors influencing PFS included BMI, HG and three radiomic features including high gray-level run emphasis, first-order minimum and first-order skewness. These risk factors were incorporated into the nomograms as independent predictive factors. PFS was substantially different between the low-risk group (total score ≤ 110) and the high-risk group (total score > 110) according to Kaplan-Meier curves (P < 0.05). CONCLUSIONS The developed predictive models for ORR and PFS in inoperable elderly ESCC patients provide valuable insights for predicting treatment efficacy and prognosis. The nomograms enable personalized treatment decision-making and can guide optimal treatment plans for inoperable elderly ESCC patients.
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Affiliation(s)
- Yong Huang
- Department of Medical Oncology, The Second People's Hospital of Hefei, Hefei, China
| | - Xiaoyu Huang
- Department of Chinese Integrative Medicine Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China
| | - Anling Wang
- Scholl of Internet, Anhui University, Hefei, China
| | - Qiwei Chen
- Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China
| | - Gong Chen
- Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China
| | - Jingya Ye
- Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China
| | - Yaru Wang
- Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China
| | - Zhihui Qin
- Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China
| | - Kai Xu
- Scholl of Internet, Anhui University, Hefei, China.
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Pape M, Veen LM, Smit TM, Kuijper SC, Vissers PAJ, Geijsen ED, van Rossum PSN, Sprangers MAG, Derks S, Verhoeven RHA, van Laarhoven HWM. Late Toxicity and Health-Related Quality of Life Following Definitive Chemoradiotherapy for Esophageal Cancer: A Systematic Review and Meta-analysis. Int J Radiat Oncol Biol Phys 2023; 117:31-44. [PMID: 37224927 DOI: 10.1016/j.ijrobp.2023.05.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2023] [Revised: 04/20/2023] [Accepted: 05/13/2023] [Indexed: 05/26/2023]
Abstract
PURPOSE Definitive chemoradiotherapy (dCRT) is a treatment option with curative intent for patients with esophageal cancer that could result in late toxicities and affect health-related quality of life (HRQoL). This study aimed to review the literature and perform a meta-analysis to investigate the effect of dCRT on late toxicities and HRQoL in esophageal cancer. METHODS AND MATERIALS A systematic search was performed in MEDLINE, EMBASE, and PsychINFO. Prospective phase II and III clinical trials, population-based studies, and retrospective chart reviews investigating late toxicity or HRQoL after dCRT (≥50 Gy) were included. The HRQoL outcomes were analyzed using linear mixed-effect models with restricted cubic spline transformation. Any HRQoL changes of ≥10 points were considered clinically relevant. The risk of toxicities was calculated using the number of events and the total study population. RESULTS Among 41 included studies, 10 assessed HRQoL and 31 late toxicity. Global health status remained stable over time and improved after 36 months compared with baseline (mean change, +11). Several tumor-specific symptoms, including dysphagia, eating restrictions, and pain, improved after 6 months compared with baseline. Compared with baseline, dyspnea worsened after 6 months (mean change, +16 points). The risk of any late toxicity was 48% (95% CI, 33%-64%). Late toxicity risk of any grade for the esophagus was 17% (95% CI, 12%-21%), pulmonary 21% (95% CI, 11%-31%), cardiac 12% (95% CI, 6%-17%), and any other organ 24% (95% CI, 2%-45%). CONCLUSIONS Global health status remained stable over time, and tumor-specific symptoms improved within 6 months after dCRT compared with baseline, with the exception of dyspnea. In addition, substantial risks of late toxicity were observed.
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Affiliation(s)
- Marieke Pape
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands; Amsterdam UMC location University of Amsterdam, Medical Oncology, Amsterdam, the Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands.
| | - Linde M Veen
- Amsterdam UMC location University of Amsterdam, Medical Oncology, Amsterdam, the Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands
| | - Thom M Smit
- Amsterdam UMC location University of Amsterdam, Medical Oncology, Amsterdam, the Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands
| | - Steven C Kuijper
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands; Amsterdam UMC location University of Amsterdam, Medical Oncology, Amsterdam, the Netherlands
| | - Pauline A J Vissers
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Elisabeth D Geijsen
- Amsterdam UMC location University of Amsterdam, Radiation Oncology, Amsterdam, the Netherlands
| | - Peter S N van Rossum
- Amsterdam UMC location University of Amsterdam, Radiation Oncology, Amsterdam, the Netherlands
| | - Mirjam A G Sprangers
- Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands; Amsterdam UMC location University of Amsterdam, Medical Psychology, Amsterdam, the Netherlands
| | - Sarah Derks
- Amsterdam UMC location Vrije Universiteit Amsterdam, Medical Oncology, Amsterdam, the Netherlands; Cancer Center Amsterdam, Cancer Biology and Immunology, Amsterdam, the Netherlands; Oncode Institute, Utrecht, the Netherlands
| | - Rob H A Verhoeven
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands; Amsterdam UMC location University of Amsterdam, Medical Oncology, Amsterdam, the Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands
| | - Hanneke W M van Laarhoven
- Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands; Amsterdam UMC location University of Amsterdam, Medical Oncology, Amsterdam, the Netherlands
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Zhang TW, Zhang P, Nie D, Che XY, Fu TT, Zhang Y. Efficacy of concurrent chemoradiotherapy with thalidomide and S-1 for esophageal carcinoma and its influence on serum tumor markers. World J Gastrointest Oncol 2023; 15:1262-1270. [PMID: 37546558 PMCID: PMC10401474 DOI: 10.4251/wjgo.v15.i7.1262] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2023] [Revised: 05/02/2023] [Accepted: 06/13/2023] [Indexed: 07/12/2023] Open
Abstract
BACKGROUND Although the current conventional treatment strategies for esophageal carcinoma (EC) have been proven effective, they are often accompanied by serious adverse events. Therefore, it is still necessary to continue to explore new therapeutic strategies for EC to improve the clinical outcome of patients.
AIM To elucidate the clinical efficacy of concurrent chemoradiotherapy (CCRT) with thalidomide (THAL) and S-1 (tegafur, gimeracil, and oteracil potassium capsules) in the treatment of EC as well as its influence on serum tumor markers (STMs).
METHODS First, 62 patients with EC treated at the Zibo 148 Hospital between November 2019 and November 2022 were selected and grouped according to the received treatment. Among these, 30 patients undergoing CCRT with cis-platinum and 5-fluorouracil were assigned to the control group (Con), and 32 patients receiving CCRT with THAL and S-1 were assigned to the research group (Res). Second, inter-group comparisons were carried out with respect to curative efficacy, incidence of drug toxicities, STMs [carbohydrate antigen 125 (CA125) and macrophage inflammatory protein-3α (MIP-3α)], angiogenesis-related indicators [vascular endothelial growth factor (VEGF); VEGF receptor-1 (VEGFR-1); basic fibroblast growth factor (bFGF); angiogenin-2 (Ang-2)], and quality of life (QoL) [QoL core 30 (QLQ-C30)] after one month of treatment.
RESULTS The analysis showed no statistical difference in the overall response rate and disease control rate between the two patient cohorts; however, the incidences of grade I–II myelosuppression and gastrointestinal reactions were significantly lower in the Res than in the Con. Besides, the post-treatment CA125, MIP-3α, VEGF, VEGFR-1, bFGF, and Ang-2 Levels in the Res were markedly lower compared with the pre-treatment levels and the corresponding post-treatment levels in the Con. Furthermore, more evident improvements in QLQ-C30 scores from the dimensions of physical, role, emotional, and social functions were determined in the Res.
CONCLUSION The above results demonstrate the effectiveness of THAL + S-1 CCRT for EC, which contributes to mild side effects and significant reduction of CA125, MIP-3α, VEGF, VEGFR-1, bFGF, and Ang-2 Levels, thus inhibiting tumors from malignant progression and enhancing patients’ QoL.
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Affiliation(s)
- Tian-Wei Zhang
- Department of Hematology and Radiotherapy, Zibo 148 Hospital, Zibo 255300, Shandong Province, China
| | - Peng Zhang
- Department of Hematology and Radiotherapy, Zibo 148 Hospital, Zibo 255300, Shandong Province, China
| | - Dong Nie
- Department of Hematology and Radiotherapy, Zibo 148 Hospital, Zibo 255300, Shandong Province, China
| | - Xin-Yu Che
- Department of Hematology and Radiotherapy, Zibo 148 Hospital, Zibo 255300, Shandong Province, China
| | - Tian-Tai Fu
- Department of Hematology and Radiotherapy, Zibo 148 Hospital, Zibo 255300, Shandong Province, China
| | - Yan Zhang
- Department of Hematology and Radiotherapy, Zibo 148 Hospital, Zibo 255300, Shandong Province, China
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Qie S, Shi H, Wang F, Liu F, Gu J, Liu X, Li Y, Sun X. Construction of survival prediction model for elderly esophageal cancer. Front Oncol 2022; 12:1008326. [PMID: 36338725 PMCID: PMC9627025 DOI: 10.3389/fonc.2022.1008326] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2022] [Accepted: 09/30/2022] [Indexed: 11/29/2022] Open
Abstract
Background The purpose of this study was to analyze the clinical characteristics and prognosis of EPEC and to construct a prediction model based on the SEER database. Methods All EPECs from the SEER database were retrospectively analyzed. A comprehensive and practical nomogram that predicts the overall survival (OS) of EPEC was constructed. Univariate and multivariate Cox regression analysis was performed to explore the clinical factors influencing the prognosis of EPEC, and finally, the 1 -, 3 - and 5-year OS were predicted by establishing the nomogram. The discriminant and predictive ability of the nomogram was evaluated by consistency index (C-index), calibration plot, area under the curve (AUC), and receiver operating characteristic (ROC) curve. Decision curve analysis (DCA) was used to evaluate the clinical value of the nomogram. Results A total of 3478 patients diagnosed with EPEC were extracted from the SEER database, and the data were randomly divided into the training group (n=2436) and the validation group (n=1402). T stage, N stage, M stage, surgery, chemotherapy, radiotherapy, age, grade, and tumor size were independent risk factors for 1 -, 3 - and 5-year OS of EPEC (P< 0.05), and these factors were used to construct the nomogram prediction mode. The C-index of the validation and training cohorts was 0.718 and 0.739, respectively, which were higher than those of the TNM stage system. The AUC values of the nomogram used to predict 1-, 2-, and 3-year OS were 0.751, 0.744, and 0.786 in the validation cohorts (0.761, 0.777, 0.787 in the training cohorts), respectively. The calibration curve of 1-, 2-, and 3-year OS showed that the prediction of the nomogram was in good agreement with the actual observation. The nomogram exhibited higher clinical utility after evaluation with the 1-, 2-, and 3-year DCA compared with the AJCC stage system. Conclusions This study shows that the nomogram prediction model for EPEC based on the SEER database has high accuracy and its prediction performance is significantly better than the TNM staging system, which can accurately and individually predict the OS of patients and help clinicians to formulate more accurate and personalized treatment plans.
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Affiliation(s)
- Shuai Qie
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Hongyun Shi
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
- *Correspondence: Hongyun Shi,
| | - Fang Wang
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Fangyu Liu
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Jinling Gu
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Xiaohui Liu
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Yanhong Li
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Xiaoyue Sun
- Department of Radiation Oncology, Baoding First Central Hospital, Baoding, China
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Survival analysis of 80 elderly patients with esophageal squamous cell carcinoma receiving definitive concurrent chemoradiotherapy with S-1. Cancer Radiother 2022; 26:1064-1069. [PMID: 35864071 DOI: 10.1016/j.canrad.2022.04.007] [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] [Revised: 03/25/2022] [Accepted: 04/10/2022] [Indexed: 11/21/2022]
Abstract
PURPOSE This single-center retrospective study aimed to observe survival and prognosis of elderly patients with esophageal cancer receiving radical radiotherapy combined with S1 chemotherapy, and to preliminarily explore whether hematologic indicators or inflammatory indicators before radiotherapy are prognostic factors. MATERIAL AND METHODS We retrospectively collected data of 80 elderly patients with esophageal cancer who had received radical concurrent chemoradiotherapy from January 2015 to July 2018. The patients were older than 70 years. Radiation therapy was delivered with intensity-modulated irradiation therapy (IMRT) or volumetric modulated arc therapy (VMAT), while the chemotherapy regimen was S1 alone. Toxicities were evaluated in accordance with the criteria of the Radiation Therapy Oncology Group. Baseline hematologic basic nutritional indicators, such as hemoglobin (HGB), albumin (ALB), and prealbumin (PAB), along with inflammatory indicators, such as the ratio of neutrophils to lymphocytes (NLR), the ratio of platelets to lymphocytes (PLR), were collected to preliminarily analyze their relationship with progression and survival. RESULTS The median follow-up time was 39 months (range 30-65 months). The median overall survival and progression-free survival times were 24 and 17 months, respectively. The 1-, 2-, and 3-year overall survival rates were 76.5%, 48.1%, and 31.3%, respectively. The 1-, 2-, and 3-year progression-free survival rates were 57.5%, 37.8%, and 29.4%, respectively. T stage, clinical staging, and lesion region were independent prognostic factors for OS. No significant associations with prognosis were observed either for baseline hematologic or for inflammatory indicators (all P>0.05). The rates of esophagitis (grade 2 and above) and hematologic toxicity were 60% and 45%, respectively. CONCLUSION Oral S-1 combined with definitive concurrent radiotherapy for elderly patients with esophageal cancer has a significant survival benefit. The toxicities are well tolerated. It seems that prognosis does not correlate with baseline hematologic nutritional indicators and inflammatory indicators.
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Guo S, Liu F, Liu H, Wu Y, Zhang X, Ye W, Luo G, Li Q, Chen N, Hu N, Wang B, Zhang J, Lin M, Feng H, Qiu B. A Prospective Phase II Study of Simultaneous Modulated Accelerated Radiotherapy Concurrently With CDDP/S1 for Esophageal Squamous Cell Carcinoma in the Elderly. Front Oncol 2021; 11:760631. [PMID: 34900709 PMCID: PMC8654786 DOI: 10.3389/fonc.2021.760631] [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: 08/18/2021] [Accepted: 11/05/2021] [Indexed: 11/13/2022] Open
Abstract
Background To explore the efficacy and toxicity of simultaneous modulated accelerated radiotherapy (SMART) concurrently with cisplatin (CDDP) and S1 (tegafur/gimeracil/oteracil) in elderly patients with esophageal squamous cell carcinoma (ESCC). Methods This single-arm, phase II study enrolled pathologically confirmed, stage II-IVa ESCC of 70-80 years old and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. Patients received SMART (64 Gy to gross tumor volume and 48 Gy to clinical target volume in 30 fractions) with concurrent CDDP (day 1 of each week) and S1 (days 1-14, 22-35). The primary endpoint was objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS) and toxicities. Results Thirty-seven eligible patients were analyzed with median follow-up of 25.7 months for all and 46.1 months for survivors. The ORR was 88.9%. Patients with baseline weight loss <5% (p=0.050) and nutritional risk index (NRI) ≥105.2 (p=0.023) had better tumor response. Median PFS was 13.8 months with 2-year PFS of 37.5%. Median OS was 27.7 months with 2-year OS of 57.5%. OS was significantly associated with ECOG PS (p=0.005), stage (p=0.014), gross tumor volume (p=0.004), baseline NRI (p=0.036), baseline C-reactive protein (CRP) level (p=0.003) and tumor response (p=0.000). CRP level (p=0.016) and tumor response (p=0.021) were independently prognostic of OS. ≥grade 3 anemia, neutropenia and thrombocytopenia occurred in 2.7%, 10.8% and 13.5% of patients; ≥grade 3 esophagitis and pneumonitis occurred in 18.9% and 2.7% of patient, respectively. Conclusion SMART concurrently with CDDP/S1 yielded satisfactory response rate, survival outcome and tolerable treatment-related toxicities in elderly patients with ESCC. Further studies are warranted to validate the results.
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Affiliation(s)
- SuPing Guo
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - FangJie Liu
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Guangdong Association Study of Thoracic Oncology, Guangzhou, China
| | - Hui Liu
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Guangdong Association Study of Thoracic Oncology, Guangzhou, China
| | - YingJia Wu
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - XuHui Zhang
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - WenFeng Ye
- State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Department of Clinical Nutrition, Sun Yat-Sen University Cancer Center, Guangzhou, China
| | - GuangYu Luo
- State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Department of Endoscopy, Sun Yat-Sen University Cancer Center, Guangzhou, China
| | - QiWen Li
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Guangdong Association Study of Thoracic Oncology, Guangzhou, China
| | - NaiBin Chen
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Guangdong Association Study of Thoracic Oncology, Guangzhou, China
| | - Nan Hu
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Guangdong Association Study of Thoracic Oncology, Guangzhou, China
| | - Bin Wang
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - Jun Zhang
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - MaoSheng Lin
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - HuiXia Feng
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
| | - Bo Qiu
- Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.,State Key Laboratory of Oncology in South China, Guangzhou, China.,Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.,Guangdong Association Study of Thoracic Oncology, Guangzhou, China
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9
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Yang X, Zhai Y, Bi N, Zhang T, Deng L, Wang W, Wang X, Chen D, Zhou Z, Wang L, Liang J. Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase II clinical trial. Chin J Cancer Res 2021; 33:53-60. [PMID: 33707928 PMCID: PMC7941689 DOI: 10.21147/j.issn.1000-9604.2021.01.06] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022] Open
Abstract
Objective To investigate the safety and efficacy of nimotuzumab combined with radiotherapy for elderly patients with non-resectable esophageal carcinoma (EC). Methods Eligible patients were aged 70 years or older and had treatment-naïve, histologically proven inoperable locally advanced EC. Enrolled patients received radiotherapy with a total dose of 50−60 Gy in 25−30 fractions, concurrent with weekly infusion of nimotuzumab. The primary end point was the rate of more than grade 3 toxicities. Results From June 2011 to July 2016, 46 patients with stage II−IV EC with a median age of 76.5 years were enrolled. There were 10, 28 and 8 patients with stage II, III and IV disease, respectively. The common acute toxicities included esophagitis (grade 1−2, 75.4%; grade 3, 8.7%), pneumonitis (grade 1, 4.3%; grade 2, 6.5%; grade 3, 2.2%), leukopenia (grade 1−2, 60.9%; grade 3−4, 4.4%), gastrointestinal reaction (grade 1−2, 17.3%; grade 3, 2.2%), thrombocytopenia (grade 1−2, 21.7%; grade 3, 2.2%), and radiothermitis (grade 1−2, 39.2%). The incidence of grade 3−4 adverse effects was 17.4%. No grade 5 toxicities were observed. Clinical complete response, partial response, stable disease, and progressive disease were observed in 1 (2.2%), 31 (67.4%), 12 (26.1%), and 2 (4.3%) patients, respectively. The median overall survival (OS) and progression-free survival (PFS) were 17 and 10 months, respectively. The 2-, 3-, and 5-year OS and PFS rates were 30.4%, 21.7%, 19.6%, and 26.1%, 19.6%, 19.6%, respectively. Conclusions Nimotuzumab combined with radiotherapy is a safe and effective therapy for elderly patients who are not surgical candidates. Further studies are warranted to confirm its therapeutic effects in elderly EC patients.
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Affiliation(s)
- Xu Yang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Yirui Zhai
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Nan Bi
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Tao Zhang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Lei Deng
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Wenqing Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Xin Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Dongfu Chen
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Zongmei Zhou
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Luhua Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
| | - Jun Liang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100121, China
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10
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Wang X, Ge X, Wang X, Zhang W, Zhou H, Lin Y, Qie S, Hu M, Wang W, Liu K, Pang Q, Li M, Chen J, Liu M, Zhang K, Li L, Shi Y, Deng W, Li C, Ni W, Chang X, Han W, Deng L, Wang W, Liang J, Bi N, Zhang T, Liu W, Wang J, Zhai Y, Feng Q, Chen D, Zhou Z, Zhao Y, Sun X, Xiao Z. S-1-Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial. Front Oncol 2020; 10:1499. [PMID: 32983991 PMCID: PMC7484368 DOI: 10.3389/fonc.2020.01499] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2020] [Accepted: 07/13/2020] [Indexed: 12/22/2022] Open
Abstract
Introduction: Intensive treatments can often not be administered to elderly patients with esophageal squamous cell carcinoma (ESCC), leading to a poorer prognosis. This multi-center phase II trial aimed to determine the toxicity profile and efficiency of S-1–based simultaneous integrated boost radiotherapy (SIB-RT) followed by consolidation chemotherapy with S-1 in elderly ESCC patients and to evaluate the usefulness of comprehensive geriatric assessment (CGA). Patients and Methods: We prospectively enrolled 46 elderly patients (age ≥ 70 years) with histopathologically proven ESCC. The patients underwent pretreatment CGA followed by SIB-RT (dose, 59.92 Gy/50.4 Gy) in 28 daily fractions administered using intensity-modulated radiotherapy or volumetric-modulated arc therapy. S-1 was orally administered (40–60 mg/m2) concurrently with radiotherapy and 4–8 weeks later, for up to four 3-week cycles at the same dose. Results: The median survival time was 22.6 months. The 1- and 2-year overall survival rates were 80.4 and 47.8%, respectively. The overall response rate was 78.3% (36/46). The incidence of grade 3–4 toxicities was 28% (13/46). The most common grade 3–4 toxicities were radiation esophagitis (5/46, 10.9%), nausea (4/46, 8.7%), anorexia (3/46, 6.5%), and radiation pneumonitis (3/46, 6.5%). There were no grade 5 toxicities. CGA identified that 48.8% of patients were at risk for depression and 65.5% had malnutrition. Conclusion: Concurrent S-1 treatment with SIB-RT followed by 4 cycles of S-1 monotherapy yielded satisfactory tumor response rates and manageable toxicities in selected elderly patients with ESCC. Pretreatment CGA uncovered numerous health problems and allowed the provision of appropriate supportive care. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02979691.
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Affiliation(s)
- Xin Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Xiaolin Ge
- Department of Radiation Oncology, Jiangsu Province Hospital (The First Affiliated Hospital With Nanjing Medical University), Nanjing, China
| | - Xiaomin Wang
- Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China
| | - Wencheng Zhang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, China
| | - Haiwen Zhou
- Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China
| | - Yu Lin
- Department of Radiation Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China
| | - Shuai Qie
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Miaomiao Hu
- Department of Oncology, Tengzhou Central People's Hospital, Tengzhou, China
| | - Wei Wang
- Department of Oncology, Tengzhou Central People's Hospital, Tengzhou, China
| | - Ke Liu
- Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
| | - Qingsong Pang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, China
| | - Minghe Li
- Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China
| | - Junqiang Chen
- Department of Radiation Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China
| | - Miaoling Liu
- Department of Radiation Oncology, Affiliated Hospital of Hebei University, Baoding, China
| | - Kaixian Zhang
- Department of Oncology, Tengzhou Central People's Hospital, Tengzhou, China
| | - Ling Li
- Department of Oncology, Tengzhou Central People's Hospital, Tengzhou, China
| | - Yonggang Shi
- Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
| | - Wei Deng
- Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China
| | - Chen Li
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Wenjie Ni
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Xiao Chang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Weiming Han
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Lei Deng
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Wenqing Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Jun Liang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Nan Bi
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Tao Zhang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Wenyang Liu
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Jianyang Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Yirui Zhai
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Qinfu Feng
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Dongfu Chen
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Zongmei Zhou
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Yidian Zhao
- Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China
| | - Xinchen Sun
- Department of Radiation Oncology, Jiangsu Province Hospital (The First Affiliated Hospital With Nanjing Medical University), Nanjing, China
| | - Zefen Xiao
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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11
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Kawamoto T, Shikama N, Oshima M, Kosugi Y, Tsurumaru M, Sasai K. Safety of radiotherapy with concurrent docetaxel in older patients with esophageal cancer. J Geriatr Oncol 2019; 11:675-679. [PMID: 31471169 DOI: 10.1016/j.jgo.2019.08.009] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2019] [Revised: 07/27/2019] [Accepted: 08/21/2019] [Indexed: 11/26/2022]
Abstract
OBJECTIVES Considering that therapeutic strategies for older adult patients with esophageal cancer (EC) remain controversial, we aimed to assess the safety of radiotherapy with concurrent docetaxel (DOC-RT) among older adult patients with EC. MATERIALS AND METHODS Eligible patients included those aged ≥76 years who were diagnosed with esophageal squamous cell carcinoma. Patients received radiotherapy (60 Gy in 30 fractions) and concurrent docetaxel (10 mg/m2 weekly for six cycles). Survival, toxicity, and treatment completion rates were retrospectively evaluated. RESULTS Among 84 older adult patients receiving radical radiotherapy or chemoradiotherapy, 73 receiving DOC-RT were studied. Median follow-up duration was 14 months (range, 2-101 months). The 1-, 3-, and 5-year overall survival rates were 63%, 33%, and 13%, respectively, with a median survival time of 21 months. Grade 3 acute toxicities included esophagitis (7%), esophageal fistula (3%), pneumonitis (1%), leukopenia (10%), and anemia (8%). Grade 3 late toxicities included esophageal stenosis (4%), pleural effusion (3%), pericardial effusion (1%), and pneumonitis (1%). Grade 4 and 5 toxicities were not observed. DOC-RT was discontinued due to deterioration in the general condition (6%), esophageal fistula (3%), pneumonia (1%), and pain (1%), resulting in a DOC-RT completion rate of 89% (65/73 patients). The non-completion group comprised a higher proportion of older adults (age ≥ 80 years) and undernourished [geriatric nutritional risk index (GNRI <92)] patients than the completion group. CONCLUSION DOC-RT can be a safe regimen for older adult patients with EC. Nonetheless, old age (≥80 years) and undernourishment (GNRI <92) should be considered prior to DOC-RT administration.
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Affiliation(s)
- Terufumi Kawamoto
- Department of Radiation Oncology, Juntendo University, Graduate School of Medicine, Japan.
| | - Naoto Shikama
- Department of Radiation Oncology, Juntendo University, Graduate School of Medicine, Japan
| | - Masaki Oshima
- Department of Radiation Oncology, Juntendo University, Graduate School of Medicine, Japan
| | - Yasuo Kosugi
- Department of Radiation Oncology, Juntendo University, Graduate School of Medicine, Japan
| | - Masahiko Tsurumaru
- Department of Esophageal and Gastroenterological Surgery, Juntendo University, Graduate School of Medicine, Japan
| | - Keisuke Sasai
- Department of Radiation Oncology, Juntendo University, Graduate School of Medicine, Japan
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12
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Li C, Wang X, Wang X, Han C, Wang P, Pang Q, Chen J, Sun X, Wang L, Zhang W, Lin Y, Ge X, Zhou Z, Ni W, Chang X, Liang J, Deng L, Wang W, Zhao Y, Xiao Z. A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer - the 3JECROG P-01 study protocol. BMC Cancer 2019; 19:397. [PMID: 31036088 PMCID: PMC6489222 DOI: 10.1186/s12885-019-5544-1] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2018] [Accepted: 03/28/2019] [Indexed: 12/27/2022] Open
Abstract
BACKGROUND The importance of definitive radiotherapy for elderly patients with esophageal and esophagogastric-junction cancer is pronounced. However, little is known in terms of the best way to combine radiotherapy with other treatment options. This study aims to compare the efficiency of SIB radiotherapy alone with SIB radiotherapy concurrent and consolidated with S-1 for elderly patients. Comprehensive geriatric assessment is also incorporated in the procedure of treatment. METHODS/DESIGN The study is a two arm, open, randomized multicenter Phase III trial with patients over 70 years old with stage IIA-IVB (UICC 2002, IVB only with metastasis to supraclavicular or celiac lymph nodes) squamous cell carcinoma or adenocarcinoma of esophagus or gastroesophageal junction. A total of 300 patients will be randomized using a 1:1 allocation ratio stratified by disease stage and study site. Patients allocated to the SIB arm will receive definitive SIB radiotherapy (95%PTV/PGTV 50.4Gy/59.92Gy/28f) while those randomized to SIB + S-1 arm will receive definitive SIB radiotherapy concurrent and consolidated with S-1. The primary endpoint of the trial is 1-year overall survival. Secondary objectives include progression-free survival, recurrence-free survival (local-regional and distant), disease failure pattern, toxicity profile as well as quality of life. Besides, detailed radiotherapy protocol and quality assurance procedure have been incorporated into this trial. DISCUSSION The proportion of elderly patients in esophageal cancer is now growing, but there is a lack of evidence in term of treatment standard for this group of patients, which is what we aim to obtain through this prospective phase III study. TRIAL REGISTRATION clinicaltrials.gov NCT02979691 . Registered November 22, 2016.
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Affiliation(s)
- Chen Li
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Xiaomin Wang
- Department 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China
| | - Xin Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Chun Han
- Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China
| | - Ping Wang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer, Tianjin, 300060, China
| | - Qingsong Pang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer, Tianjin, 300060, China
| | - Junqiang Chen
- Department of Radiation Oncology, Fujian Cancer Hospital/Fujian Medical University Cancer Hospital, Fuzhou, 350014, China
| | - Xinchen Sun
- Department of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China
| | - Lan Wang
- Department of Radiation Oncology, the Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China
| | - Wencheng Zhang
- Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital/National Clinical Research Center for Cancer, Tianjin, 300060, China
| | - Yu Lin
- Department of Radiation Oncology, Fujian Cancer Hospital/Fujian Medical University Cancer Hospital, Fuzhou, 350014, China
| | - Xiaolin Ge
- Department of Radiation Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China
| | - Zongmei Zhou
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Wenjie Ni
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Xiao Chang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Jun Liang
- Department of Radiation Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, 518000, China
| | - Lei Deng
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Wenqing Wang
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Yidian Zhao
- Department 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China.
| | - Zefen Xiao
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
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13
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Song T, Fang M, Wu S. Concurrent chemoradiation therapy tailored to the older adults with esophageal cancer: state of the art and the future. Clin Interv Aging 2018; 13:2275-2287. [PMID: 30519009 PMCID: PMC6233861 DOI: 10.2147/cia.s179014] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022] Open
Abstract
Purpose The aim of this study was to review the published literature addressing the question of whether geriatric assessment (GA) should be routinely applied in the treatment of older adults with esophageal cancer (EC) who have received definitive concurrent chemoradiotherapy (dCRT). Materials and methods A literature search of PubMed, Embase, and Cochrane Library was performed. Studies that contained original data outlining the inclusion and exclusion criteria, treatment compliance rate, and severe toxicity reports were reviewed. Additionally, criteria from ongoing clinical trials in the World Health Organization and National Institutes of Health registries were reviewed to evaluate the utilization of GA-related domains in elderly EC patients who received dCRT. Results Twenty-nine studies were identified based on the selection criteria: five were single-arm prospective studies, and the other studies were retrospective studies. All studies used chronological age and performance status as basic descriptors for this subpopulation. The comorbidity index and the malnutrition level were mentioned in several studies. However, factors such as “Demographic data and social support,” “Psychology,” “Polypharmacy,” and “Geriatric syndromes” were not described in any of the included studies. Unfortunately, the results were similar for the registered clinical trials. Finally, treatment compliance and toxicity profile were found to be acceptable in selected elderly EC patients. Conclusion The current experience for older adults with EC receiving dCRT is mainly based on the results of a series of retrospective studies. Ongoing clinical trials should routinely consider GA-related domains to select appropriate treatments for patients in the future.
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Affiliation(s)
- Tao Song
- Department of Radiation Oncology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310000, Zhejiang, People's Republic of China
| | - Min Fang
- Department of Radiation Oncology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310000, Zhejiang, People's Republic of China
| | - Shixiu Wu
- Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou 310000, Zhejiang, People's Republic of China,
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Wang W, Xing D, Song Y, Liu F. Effects of S-1 combined with radiotherapy in the treatment of advanced esophageal cancer: A systematic review and meta-analysis protocol. Medicine (Baltimore) 2018; 97:e0164. [PMID: 29561425 PMCID: PMC5895356 DOI: 10.1097/md.0000000000010164] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2018] [Accepted: 02/27/2018] [Indexed: 01/10/2023] Open
Abstract
BACKGROUND Esophageal cancer is one of the worst malignant digestive neoplasms with poor treatment outcomes. Definitive concurrent chemoradiotherapy (CRT) has become the standard nonsurgical treatment option for locally advanced esophageal cancer. The chemotherapeutic drugs 5-fluorouracil and cisplatin have been most commonly used in CRT of esophageal cancer. However, radiotherapy combined with 5-FU/cisplatin often delivers severe toxicity to patients. S-1 as an oral chemotherapeutic drug exhibits higher anti-tumor activity, less adverse effects, and better biological availability. S-1 also has excellent effects as a CRT regimen for esophageal cancer. METHODS A systematic literature search will be performed through January 2018 using MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and Google Scholar for relevant articles published in any language. Randomized controlled trials, prospective comparative studies will be included. All meta-analyses will be performed using Review Manager software. The quality of the studies will be evaluated using the guidelines listed in the Cochrane Handbook. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements will be followed until the findings of the systematic review and meta-analysis are reported. RESULTS The results of this systematic review and meta-analysis will be published in a peer-reviewed journal. CONCLUSION Our study will draw an objective conclusion of the effects of S-1 combined with radiotherapy in the treatment of unresectable esophageal cancer and provide level I evidence for clinical decision makings.
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Affiliation(s)
- Wei Wang
- Department of Thoracic Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China
- Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
| | | | - Yingjian Song
- Department of Thoracic Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China
| | - Feiyu Liu
- Department of Pharmacy, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China
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