To test whether dose-escalated single fraction (SF) stereotactic body radiotherapy (SBRT) of 20 Gy to painful bone metastases is superior to conventional SF three-dimensional (3D) conformal radiotherapy (RT) to a standard dose of 8 Gy in achieving complete pain response (CR).

A single-blind, randomized, controlled, phase III trial (ROBOMET) included 126 patients with up to three painful bone metastases, randomly assigned between April 2019 and October 2022 at multiple centers in Belgium. Inclusion criteria were uncomplicated painful bone metastases (worst pain score ≥2 on a 0-10 pain scale) arising from a solid tumor. Treatment consisted of either a single SBRT fraction of 20 Gy or a single conventional RT fraction of 8 Gy. The primary end point was the proportion of patients with a CR 1 month after RT scored according to the International Consensus on Palliative Radiotherapy Endpoints analyzed as per an intention-to-treat principle.

After 1 month, 16 of 63 (25% [95% CI, 15 to 38]) patients treated with conventional RT achieved CR versus 23 of 63 (37% [95% CI, 25 to 50]) treated with SBRT (P = .25). After 3 months, 15 of 63 (24% [95% CI, 14 to 36]) patients achieved CR after conventional RT versus 21 of 63 (33% [95% CI, 22 to 46]) after SBRT (P = .32). Among patients evaluable after 3 months and treated per protocol, the SBRT group had more complete responders (21/39, 54% [95% CI, 37 to 70]) than the conventional RT group (15/48, 31% [95% CI, 19 to 46]; P = .048).

SBRT failed to demonstrate improved CR rates after 1 month.

Combination therapy for metastatic hormone-sensitive prostate cancer (mHSPC) has been widely adopted, yet clinical use and outcomes are unknown. Furthermore, optimal therapy is uncertain due to lack of direct comparison of androgen receptor pathway inhibitors (ARPIs) and docetaxel in high-volume disease.

To evaluate the use of combination therapy and its association with overall survival among patients with mHSPC and to compare ARPIs vs docetaxel doublet therapy by volume of disease.

This retrospective cross-sectional study was conducted in the US Veterans Health Administration among 6216 US veterans with de novo mHSPC from January 1, 2013, to December 31, 2022, treated with androgen deprivation therapy (ADT) within 3 months of diagnosis. Treatments for mHSPC were collected within 4 months of ADT. Volume of disease was assessed from radiology report review. Data were analyzed from July 2023 to October 2024.

Overall survival (OS) and clinical progression-free survival (PFS), indicated by time to castration resistance or death.

Among 6216 male veterans with mHSPC (mean [SD] age, 73.9 [9.7] years), use of combination therapy increased from 344 of 637 veterans (54.0%) in 2020 to 465 of 737 veterans (63.1%) in 2022. Among 4106 veterans treated from 2017 to 2022, combination therapy was associated with longer OS (40.3 [95% CI, 38.0-42.1] months vs 33.0 [95% CI, 31.2-35.1] months; hazard ratio [HR], 0.80 [95% CI, 0.74-0.87]) and was used more frequently among younger veterans with fewer comorbidities. Among 1174 veterans with high-volume mHSPC, there was no difference in OS between ARPIs and docetaxel (32.3 [95% CI, 29.5-35.3] months vs 34.7 [95% CI, 31.7-37.1] months; HR, 1.06 [95% CI, 0.91-1.23]); however, ARPIs were associated with longer PFS (18.7 [95% CI, 17.1-20.9] months vs 16.0 [95% CI, 14.0-17.7] months; HR, 0.80 [95% CI, 0.70-0.91]; P = .001). In a multivariable model of high-volume mHSPC, there was no difference in OS between ARPIs and docetaxel (adjusted HR, 0.89 [95% CI, 0.76-1.05]). Among 366 veterans with low-volume mHSPC, there was no difference in OS between ARPIs and docetaxel (68.4 [95% CI, 52.6 months to not reached] months vs 55.3 [95% CI, 41.7-78.9] months; HR, 0.81 [95% CI, 0.58-1.13]), but ARPIs were associated with longer PFS (39.7 [95% CI, 34.3-52.9] months vs 24.0 [95% CI, 20.3-32.9] months; HR, 0.57 [95% CI, 0.43-0.76]).

In this cross-sectional study of veterans with de novo mHSPC, use of combination therapies increased over time and were associated with longer survival compared with ADT monotherapy. In both high- and low-volume mHSPC, no differences in OS were observed between ARPI and docetaxel combinations; however, ARPIs had longer PFS. Future research into the role of docetaxel is needed to elucidate the benefit of chemotherapy in mHSPC.

Develop an instrument to assess unmet needs in cancer patients using immuno-, biological and precision (IBP) therapies.

Development followed COSMIN guidance. Instruments to assess unmet needs of advanced cancer patients were identified, and quality and content were evaluated in a systematic review (Phase 1). Semi-structured interviews with patients utilising IBP therapies (n = 31) and healthcare professionals (n = 22) explored supportive care needs (Phase 2). Phase 3 selected a base instrument to adapt, generated new items and iteratively refined these through six meetings involving professionals (n = 8) and public and patient involvement representatives (n = 9) and patient cognitive interviews (n = 16). Phase 4 piloted the new instrument (n = 50 patients).

Twenty-four instruments were identified; none was developed for patients utilising IBP therapies (Phase 1). Ten domains of unmet needs were identified from the interview data (Phase 2). SCNS-SF34 was selected as the base instrument. Informed by interview data, an "add-on module" (SCNS-TARGET) was developed for patients utilising IBP therapies comprising 25 questions (psychological domain, 7 items; information, 6; healthcare, 5; economic, 3; role, 2; physical, 1; social, 1; Phase 3). Levels of missingness were low; reliability varied across questions, and, on average, patients reported 7.40 (standard deviation = 8.43) unmet needs on SCNS-TARGET (Phase 4).

SCNS-TARGET is designed for use alongside SCNS-SF34 to assess unmet needs in those using IBP therapies. Content and face validity have been established.

SCNS-TARGET can help researchers and healthcare professionals determine unmet needs and inform requirements for new services and interventions, among patients using IBP therapies.

Pancreatic cancer remains one of the most aggressive malignancies with limited treatment options and poor survival rates. Vitamin D deficiency has been suggested to influence cancer progression and survival outcomes in various malignancies.

This study aimed to investigate the association between Vitamin D deficiency and disease progression as well as survival in patients diagnosed with pancreatic cancer.

A retrospective cohort study was conducted, including 151 patients diagnosed with pancreatic cancer between 2012 and 2022. Serum Vitamin D levels at the time of diagnosis were measured. Disease progression was evaluated through radiological assessments and clinical reports. Survival outcomes, including overall survival (OS) and progression-free survival (PFS), were analyzed using Kaplan-Meier survival curves and Cox proportional hazards regression models.

Of the 151 patients, 84 (56 %) were identified as Vitamin D deficient at the time of diagnosis. The deficient group exhibited a significantly higher frequency of advanced-stage disease (stages III and IV) compared to the non-deficient group (p < 0.05). During the follow-up period, 66 (78.6 %) of Vitamin d-deficient patients and 56 (84.8 %) of non-deficient patients experienced disease progression (p = 0.51). Moreover, Kaplan-Meier analysis showed a non-significant trend toward shorter median PFS (8.95 months vs. 9.27 months, p = 0.51) and OS (17.64 months vs. 19.05 months, p = 0.616) in the Vitamin d-deficient group.

Vitamin D deficiency is prevalent among patients with pancreatic cancer and appears to be associated with more advanced disease at diagnosis. Although a trend toward poorer survival outcomes was observed, the association between Vitamin D deficiency and OS/PFS did not reach statistical significance. Additional prospective studies are needed to confirm these findings and explore potential benefits of Vitamin D supplementation in pancreatic cancer management.

In the Netherlands oncological drug approvals by the European Medicines Agency (EMA) are evaluated for added clinical benefit by the cieBOM (commission 'Beoordeling Oncologische Middelen'). A positive evaluation (further depicted as 'approval') by the cieBOM is of value in drug reimbursement decision making. In this study we explore characteristics of drug evaluations by the cieBOM.

We identified new drugs and drug indications for malignant solid tumours approved by the American Food and Drug Administration (FDA) and/or EMA from January 2016 to December 2020 and compared these to assessments by the cieBOM.

A total of 136 new drug indications were identified of which 133 were evaluated by the FDA, 111 were evaluated by EMA and 87 were evaluated by cieBOM. The cieBOM initially approved 76 of 104 (73 %) EMA-approved indications, and 76 of 124 (61 %) of all FDA-approved indications. cieBOM approvals were more often based on phase III trials. Neither the percentage of approvals with an OS benefit, nor the magnitude of benefit, nor the hazard ratio for death differed significantly between agencies. PFS and QoL gains for approvals were also similar between agencies.

The cieBOM evaluated less new drug indications and subsequently approved less often as compared to the EMA and the FDA, with approvals more frequently based on phase III trials. The gain in clinical or surrogate endpoints did not differ between cieBOM and FDA or EMA approvals. Globally, stricter criteria for both selection of studies to be assessed by advisory commissions such as cieBOM and drug approval agencies are needed in order to limit the advent of new drugs and drug indications to only those of high value.

To examine socioeconomic disparities in health-related quality of life (HRQoL) and healthcare use during the last year of life of patients with advanced cancer.

Data was used from a prospective, longitudinal, multicenter, observational study of patients with advanced cancer in forty Dutch hospitals (eQuiPe). Adult patients with stage IV cancer completed 3-monthly questionnaires until death. Socioeconomic position (SEP) was defined as estimated income on street-level. Mixed-effects regression analysis was used to identify associated factors.

A total of 639 patients were included, 14% with a lower SEP, 59% medium SEP and 28% higher SEP. Patients with a lower SEP were more often lower educated (40% vs. 18%, p < 0.001) and less often reported to have a partner (61% vs. 90%, p < 0.001) than those with a higher SEP. In the last year of life, patients with lower SEP were more likely to experience disease-related financial difficulties than those with higher SEP (28% vs. 12%, p = 0.001; β 8.2, 95%CI 2.9-13.3). No significant associations were found between SEP and HRQoL, hospital admissions or emergency department admissions. Although, patients with lower SEP had more frequent (≥ 5 per month) interactions with healthcare professionals than patients with higher SEP in the last year of life (OR 1.9, 95%CI 1.0-3.5).

Some socioeconomic disparities are present during the last year of life of patients with advanced cancer. It is important for clinicians to be aware of the greater financial impact and higher healthcare utilization in patients with a lower SEP to ensure equitable end-of-life care.

To characterize the perceptions of surgeons, anesthesiologists, and geriatricians regarding perioperative cardiopulmonary resuscitation (CPR) in surgical patients with frailty.

The population of patients undergoing surgery is growing older and more frail. Despite a growing focus on goal-concordant care, frailty assessment, and debate regarding the appropriateness of CPR in patients with frailty, providers' views regarding frailty and perioperative CPR are unknown.

We performed qualitative thematic analysis of transcripts from semistructured interviews of anesthesiologists (8), surgeons (10), and geriatricians (9) who care for high-risk surgical patients at 2 academic medical centers in Boston, MA. The interview guide elicited clinicians' understanding of frailty, approach to decision-making regarding perioperative CPR, and perceptions of perioperative CPR in frail surgical patients.

We identified 5 themes: (1) perceptions of perioperative CPR in patients with frailty vary by provider specialty, (2) judgments regarding the appropriateness of CPR in surgical patients with frailty are typically multifactorial and include patient goals, age, comorbidities, and arrest etiology, (3) resuscitation in patients with frailty is sometimes associated with moral distress, (4) biases, such as ableism and ageism, may skew clinicians' perceptions of the appropriateness of perioperative CPR in patients with frailty, and (5) evidence to guide risk stratification for patients with frailty undergoing perioperative CPR is inadequate.

Anesthesiologists, surgeons, and geriatricians offer different accounts of frailty's relevance to judgments regarding CPR in surgical patients. Divergent views regarding frailty and perioperative CPR may impede efforts to deliver goal-concordant care and suggest a need for research to inform risk stratification, predict patient-centered outcomes, and understand the role of potential biases, such as ageism and ableism.

Cutaneous melanoma (CM) is the leading cause of skin cancer mortality with associated high healthcare costs. Up-to-date reporting of epidemiological trends for CM is required to project future trends, assess the burden of disease and aid evaluation of new diagnostic, therapeutic and preventative strategies.

To describe the trends in CM mortality, incidence, mortality-to-incidence indices (MIIs) and disability-adjusted life years (DALYs) over the last three decades.

A population-based cross-sectional study of the Global Burden of Disease (GBD) database between 1990 and 2019 was performed. Nineteen high-income countries with similar health expenditure and classified as having high-quality mortality data including the United Kingdom, the United States, Australia and selected European Union countries were included. Annual age-standardized incidence rates (ASIRs), age-standardized death rates (ASDRs) and DALYs for each country were extracted. Mortality-to-incidence indexes were calculated by dividing the ASDR by the ASIR. Trends were described using Joinpoint regression analysis.

Almost all countries demonstrated increasing ASDR in males over the observation period with greatest percentage increase in Greece (+87%), and there was greater heterogeneity between countries in females. CM mortality was greater for males than females in all countries. Most recent Joinpoint analysis shows significantly decreasing mortality in all countries except the United Kingdom (+0.5% males between 2007 and 2019, +0.1% females between 2002 and 2019). Incidence rates increased in all countries, with evidence of plateau from 2015 onwards. While MIIs cannot be used as a proxy for survival, statistically significant decreases in MII were observed in all countries. Overall, DALYs remained static.

Over the past 30 years, CM mortality and incidence has increased in most EU15+ countries. There is evidence that in recent years, CM mortality is decreasing. The burden of disease as assessed using DALYs has remained mostly unchanged. Future work should not solely focus on expensive innovative therapies, but also on optimizing primary prevention.

This study evaluated the real-world efficacy and safety of combining PARP inhibitors with novel hormonal therapy (NHT) as a first-line treatment in Chinese patients with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene mutations.

We enrolled 41 mCRPC patients who received at least 1 month of combined treatment with PARP inhibitors and NHT. Patients were divided into two groups: Cohort A (mutations in BRCA1, BRCA2, or ATM genes) and Cohort B (mutations in other HRR genes). The primary endpoint was imaging-based progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), disease control rate (DCR), overall survival (OS), PSA50 response, and adverse events (AEs). To ensure accurate research results and control confounding factors, we will employ multivariate Cox proportional hazards models to evaluate key variables affecting mCRPC patient survival outcomes.

This study enrolled 41 patients, 22 in Cohort A and 19 in Cohort B. The median PFS for all patients was 21.8 months, and the median OS had yet to be reached. The overall ORR was 48.8%, and the DCR was 61.0%. Specifically, the median PFS for Cohort A was 21.8 months compared to 14.5 months for Cohort B. The median OS had yet to be reached for either cohort. Regarding efficacy, 81.8% of patients in Cohort A and 73.7% in Cohort B achieved a PSA50 response. Imaging assessments showed ORRs of 54.6% for Cohort A and 42.1% for Cohort B, with DCRs of 72.7% and 47.4%, respectively. 85.4% of patients experienced grade 1 or 2 adverse events, and 51.2% encountered grade 3 or 4. In the multivariate Cox regression analysis focusing on PFS, the Gleason score was identified as a significant predictor (HR = 5.8, 95% CI: 1.65-20.2, p = 0.006).

Combined first-line treatment with PARP inhibitors and NHT is effective and well-tolerated in mCRPC patients with HRR gene mutations, particularly those with BRCA1, BRCA2, or ATM mutations. These findings underscore the potential of this therapeutic combination in managing mCRPC in the Chinese population, suggesting a favorable outcome for those with specific genetic backgrounds.

Financial conflicts of interest (FCOI) of medical professionals and associated organizations with pharmaceutical companies (pharma) might contribute to the use of low value oncological treatments. Value criteria for oncological drug approvals in the Netherlands have recently become more stringent leading to objections by cancer patient advocacy organizations (cPAOs). Considering the importance of cPAOs input in cancer patient care we analyzed whether pharma funding of cPAOs occurs in the Netherlands.

The cPAO websites and available annual reports were evaluated for disclosure of pharma funding for the years 2021 and 2022. Also, data from the Dutch Healthcare Transparency Registry (DHTR) were extracted.

Twenty-one of 34 (61.8 %) cPAOs received pharma funding (with 20 registered in the DHTR), and for 13 (29.4 %) cPAOs no reporting of pharma funding could be found. Three of the cPAOs disclosed pharma funding directly on their main website. Online educational material was available from 22 cPAOs on their websites with pharma funding disclosed on the educational material in 5. The total registered amount of pharmaceutical funding was €667,232.00 in 2021 and €536,098.00 in 2022. The median (and interquartile ranges) DHTR registered amount of support per cPAO that received funding in the studied period was €23,799.50 (14,823.75-84,663.30). The most common funding category as defined in the DHTR was project sponsorship.

Financial support by the pharmaceutical industry is common for Dutch cPAOs. Given the importance of cPAOs and their objective input in the societal debate on the availability of cancer drugs, the potential influence of pharma sponsoring should be critically evaluated.

The time toxicity of anticancer therapy, defined as days spent with healthcare contact during treatment, represents a critical but understudied outcome. This study aims to quantify time toxicity among older patients with cancer receiving palliative systemic treatment.

All patients aged ≥ 65 years with metastatic cancer receiving cytotoxic chemotherapy, immunotherapy, or targeted therapy at a single center in Mexico were selected from a prospective patient navigation cohort. Patients completed a baseline assessment, including the G8 screening and quality of life measures. Physical healthcare contact days within the first 6 months were extracted from medical records and divided by days alive during the same period. Beta regression models were used to identify predictors of time toxicity.

We identified 158 older patients (median age 71 years); 86% received cytotoxic chemotherapy. Seventy-three percent had an impaired G8 score and were considered vulnerable/frail. Six-month overall survival was 74%. Within the first 6 months, patients spent a mean of 21% (95% confidence interval (CI) 19-23%) of days with healthcare contact. Concurrent radiotherapy (odds ratio (OR) 1.55; 95%CI 1.21-1.97), cytotoxic chemotherapy versus targeted therapy (OR 1.64; 95%CI 1.13-2.37), and an impaired G8 (OR 1.27; 95%CI 1.01-1.60) were associated with increased time toxicity.

Older adults with metastatic cancer spend 1 in 5 days with healthcare contact during treatment, with a higher burden of time toxicity for patients receiving radiotherapy or cytotoxic chemotherapy and those with potential frailty. These findings underscore the importance of informing patients about their expected healthcare contact days within the context of a limited life expectancy.

Gastrointestinal stromal tumors (GIST) are the most common mesenchymal-derived tumors of the GI tract. They can occur throughout the GI tract, and the survival time of some patients can be improved by first-line targeted therapy with imatinib. However, there are some limitations with imatinib treatment. Immunotherapy for GIST has attracted much attention in recent years, and as one of the most abundant cells in the GIST microenvironment, M2 macrophages play an important role in disease progression. They have unique anti-inflammatory and pro-tumorigenic effects and are one target for immunotherapy. This review summarizes the connection between different factors and the programmed death receptor-1/programmed death ligand-1 pathway and M2 macrophages to reactivate or enhance anti-tumor immunity and improve imatinib efficacy, and to provide new ideas for GIST immunotherapy.

Health care expenditure related to oncologic treatments is skyrocketing although many treatments offer marginal, if any, clinical benefit. Financial conflicts of interest (fCOI) resulting from pharmaceutical industry (pharma) payments to physicians is increasingly recognized as a predictive factor for regulatory board approval and guideline incorporation of low-value treatments. We sought to study the extent to which pharma payments to medical oncologists occur in the Netherlands, the amount of money involved, and whether these occur more frequently and are higher for key opinion leaders (KOLs).

In our cross-sectional retrospective database study, we used several Dutch open-access databases and extracted data registered between 2019 and 2021.

A cumulative amount of €899,863 was paid to 48.8% of the 408 registered medical oncologists. Over time, there was a marked decline in both the proportion of medical oncologists receiving payments (from 40.4% in 2019 to 19.1% in 2021) and the mean annual value of payments (from €2,962 in 2019 to €2,188 in 2021) with the latter mainly resulting from a decline in hospitality-related transactions. KOLs were more likely to receive industry payments and received a higher median payment value.

Our findings should contribute to the increasing awareness in the Netherlands of the potential effects of fCOI.

During the COVID-19 pandemic recommendations were made to adapt cancer care. This population-based study aimed to investigate possible differences between the treatment of patients with metastatic cancer before and during the pandemic by comparing the initial treatments in five COVID-19 periods (weeks 1-12 2020: pre-COVID-19, weeks 12-20 2020: 1st peak, weeks 21-41 2020: recovery, weeks 42-53 2020: 2nd peak, weeks 1-20 2021: prolonged 2nd peak) with reference data from 2017 to 2019. The proportion of patients receiving different treatment modalities (chemotherapy, hormonal therapy, immunotherapy or targeted therapy, radiotherapy primary tumor, resection primary tumor, resection metastases) within 6 weeks of diagnosis and the time between diagnosis and first treatment were compared by period. In total, 74,208 patients were included. Overall, patients were more likely to receive treatments in the COVID-19 periods than in previous years. This mainly holds for hormone therapy, immunotherapy or targeted therapy and resection of metastases. Lower odds were observed for resection of the primary tumor during the recovery period (OR 0.87; 95% CI 0.77-0.99) and for radiotherapy on the primary tumor during the prolonged 2nd peak (OR 0.84; 95% CI 0.72-0.98). The time from diagnosis to the start of first treatment was shorter, mainly during the 1st peak (average 5 days, p < .001). These findings show that during the first 1.5 years of the COVID-19 pandemic, there were only minor changes in the initial treatment of metastatic cancer. Remarkably, time from diagnosis to first treatment was shorter. Overall, the results suggest continuity of care for patients with metastatic cancer during the pandemic.

Carcinoid syndrome (CS) is a debilitating disease that affects approximately 20% of patients with neuroendocrine neoplasms (NEN). Due to the increasing incidence and improved overall survival of patients with NEN over recent decades, patients are increasingly suffering from chronic and refractory CS symptoms. At present, symptom control is hampered by an incomplete understanding of the pathophysiology of this syndrome. This systematic review is the first to critically appraise the available evidence for the various hormonal mediators considered to play a causative role in CS. Overall, evidence for the putative mediators of CS was scarce and often of poor quality. Based on the available literature, data are only sufficient to agree on the role of serotonin as a mediator of CS-associated diarrhea and fibrosis. A direct role for tachykinins and an indirect role of catecholamines in the pathogenesis of CS is suggested by several studies. Currently, there is insufficient evidence to link histamine, bradykinin, kallikrein, prostaglandins, or motilin to CS. To summarize, available literature only sufficiently appoints serotonin and suggests a role for tachykinins and catecholamines as mediators of CS, with insufficient evidence for other putative mediators. Descriptions of CS should be revised to focus on these proven hormonal associations to be more accurate, and further research is needed into other potential mediators.

Metastatic castration-resistant prostate cancer (mCRPC) remains incurable and develops from biochemically recurrent PC treated with androgen deprivation therapy (ADT) following definitive therapy for localized PC, or from metastatic castration-sensitive PC (mCSPC). In the mCSPC setting, treatment intensification of ADT plus androgen receptor (AR)-signaling inhibitors (ARSIs), with or without chemotherapy, improves outcomes vs ADT alone. Despite multiple phase 3 trials demonstrating a survival benefit of treatment intensification in PC, there remains high use of ADT monotherapy in real-world clinical practice. Prior studies indicate that co-inhibition of AR and poly(ADP-ribose) polymerase (PARP) may result in enhanced benefit in treating tumors regardless of alterations in DNA damage response genes involved either directly or indirectly in homologous recombination repair (HRR). Three recent phase 3 studies evaluated the combination of a PARP inhibitor (PARPi) with an ARSI as first-line treatment for mCRPC: TALAPRO-2, talazoparib plus enzalutamide; PROpel, olaparib plus abiraterone acetate and prednisone (AAP); and MAGNITUDE, niraparib plus AAP. Results from these studies have led to the recent approval in the United States of talazoparib plus enzalutamide for the treatment of mCRPC with any HRR alteration, and of both olaparib and niraparib indicated in combination with AAP for the treatment of mCRPC with BRCA alterations.

Here, we review the newly approved PARPi plus ARSI treatments within the context of the mCRPC treatment landscape, provide an overview of practical considerations for the combinations in clinical practice, highlight the importance of HRR testing, and discuss the benefits of treatment intensification for patients with mCRPC.

In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's Accelerated Approval Program, we observe a tendency towards fast approval for exploratory studies with non-randomised, uncontrolled designs and surrogate endpoints. This issue raises concerns about the robustness and effectiveness of accepted treatments, leaving patients and health-care professionals in a state of uncertainty. A substantial number of accelerated approvals have recently been withdrawn in the USA, with some still authorised in Europe, emphasising discrepancies in regulatory standards that affect both patients and society as a whole. We highlight examples of drugs, authorised on the basis of surrogate endpoints, that were later withdrawn due to an absence of overall survival benefit. Our findings address the challenges and consequences of accelerated approval pathways in oncology. In conclusion, this Policy Review calls for regulatory bodies to better align their procedures and insist on robust evidence, preferably through unbiased randomised controlled trials. Drug approval processes should prioritise patient benefit, overall survival, and quality of life to minimise risks and uncertainties for patients.

Cancer affects one in two people in the UK and the incidence is set to increase. The UK National Health Service is facing major workforce deficits and cancer services have struggled to recover after the COVID-19 pandemic, with waiting times for cancer care becoming the worst on record. There are severe and widening disparities across the country and survival rates remain unacceptably poor for many cancers. This is at a time when cancer care has become increasingly complex, specialised, and expensive. The current crisis has deep historic roots, and to be reversed, the scale of the challenge must be acknowledged and a fundamental reset is required. The loss of a dedicated National Cancer Control Plan in England and Wales, poor operationalisation of plans elsewhere in the UK, and the closure of the National Cancer Research Institute have all added to a sense of strategic misdirection. The UK finds itself at a crossroads, where the political decisions of governments, the cancer community, and research funders will determine whether we can, together, achieve equitable, affordable, and high-quality cancer care for patients that is commensurate with our wealth, and position our outcomes among the best in the world. In this Policy Review, we describe the challenges and opportunities that are needed to develop radical, yet sustainable plans, which are comprehensive, evidence-based, integrated, patient-outcome focused, and deliver value for money.

Benchmarking is crucial for healthcare providers to enhance quality and efficiency, notably for complex conditions like sarcomas. Multidisciplinary teams/sarcoma boards (MDT/SBs) are vital in sarcoma management, but differences in their processes can affect patient outcomes and treatment costs, despite adherence to international guidelines. To address this issue, this study aimed to compare two MDT/SBs and establish an interoperable digital platform, Sarconnector®, for real-time-world data assessment and automated analysis. The study included 983 patients, 46.0% of whom female, with a median age of 58 years, and 4.5% of patients presented with metastasis at diagnosis. Differences were observed in the number of first-time presentations, follow-up presentations, primary sarcomas, biopsies and chemotherapy indications between the two MDT/SB. The results highlight the importance of benchmarking and utilizing a harmonized data approach, such as the RWT approach provided by the Sarconnector®, to standardize and evaluate quality and cost metrics. By identifying areas of improvement and making data-driven decisions on the meta-level, healthcare providers can optimize resources and improve patient outcomes. In conclusion, benchmarking with the RWT harmonized data approach provided by the Sarconnector® can help healthcare providers improve the overall effectiveness of the healthcare system and achieve better outcomes for their patients in terms of both outcomes and costs.

Survival studies are important tools for cancer control, but long-term survival data on high-quality cancer registries are lacking for all cancers, including prostate (PC), testicular (TC), and penile cancers. Using generalized additive models and data from the NORDCAN database, we analyzed 1- and 5-year relative survival for these cancers in Denmark (DK), Finland (FI), Norway (NO), and Sweden (SE) over a 50-year period (1971-2020). We additionally estimated conditional 5/1-year survival for patients who survived the 1st year after diagnosis. Survival improved early for TC, and 5-year survival reached 90% between 1985 (SE) and 2000 (FI). Towards the end of the follow-up, the TC patients who had survived the 1st year survived the next 4 years with comparable probability to the background population. For PC, the 90% landmark was reached between 2000 (FI) and after 2010 (DK). For penile cancer, 5-year survival never reached the 90% landmark, and the improvements in survival were modest at best. For TC, early mortality requires attention, whereas late mortality should be tackled for PC. For penile cancer, the relatively high early mortality may suggest delays in diagnosis and would require more public awareness and encouragement of patients to seek medical opinion. In FI, TC and penile cancer patients showed roughly double risk of dying compared to the other Nordic countries, which warrants further study and clinical attention.

The incidence of prostate cancer (PC) increased vastly as a result of prostate-specific antigen (PSA) testing. Survival in PC improved in the PSA-testing era, but changes in clinical presentation have hampered the interpretation of the underlying causes.

We analyzed survival trends in PC using data from the NORDCAN database for Denmark (DK), Finland (FI), Norway (NO) and Sweden (SE) by analyzing 1-, 5- and 10-year relative survival and conditional relative survival over the course of 50 years (1971-2020).

In the pre-PSA era, survival improved in FI and SE and improved marginally in NO but not in DK. PSA testing began toward the end of the 1980s; 5-year survival increased by approximately 30%, and 10-year survival improved even more. Conditional survival from years 6 to 10 (5 years) was better than conditional survival from years 2 to 5 (4 years), but by 2010, this difference disappeared in countries other than DK. Survival in the first year after diagnosis approached 100%; by year 5, it was 95%; and by year 10, it was 90% in the best countries, NO and SE.

In spite of advances in diagnostics and treatment, further attention is required to improve PC survival.