JCO oncology practice最新文献

{"title":"Oncology Medical Homes: ASCO-Community Oncology Alliance Standards.","authors":"Kim Woofter, Erin B Kennedy, Kerin Adelson, Ronda Bowman, Andrew E Chapman, Niharika Dixit, Rose Gerber, Paula Jefferies, Eric Martin, Therese M Mulvey, MiKaela Olsen, Deirdre O'Mahony, Blase Polite, Navid Sadeghi, Melissa Shaw, Matthew R Skelton, John Cox","doi":"10.1200/OP-25-00498","DOIUrl":"https://doi.org/10.1200/OP-25-00498","url":null,"abstract":"<p><strong>Purpose: </strong>To update Standards for an Oncology Medical Home (OMH) certification program on the basis of evidence and expert consensus. OMH is a system of care delivery that models coordinated, efficient, accessible, and evidence-based care reinforced by measurement of outcomes to facilitate continuous quality improvement.</p><p><strong>Methods: </strong>An Expert Panel formed to review and update the OMH Standards. The Panel updated the 2021 systematic literature review on the topics of OMH model of care, clinical pathways, and survivorship care plans (SCPs). New topics for this update include safety and just culture in health care, multidisciplinary team (MDT) management, and geriatric assessment. An informal consensus process was used to revise, update, and add new standards. The process incorporated practice experience gained from a pilot certification process on the basis of the standards. Input was gained from open comment and external review before finalization.</p><p><strong>Results: </strong>No new evidence was identified to warrant revisions to standards on the overarching OMH model of care, SCPs, and clinical pathways originally reported in the 2021 ASCO-Community Oncology Alliance OMH Standards. An additional literature search on safety and just culture in oncology identified three integrative reviews and one systematic review. This evidence, combined with existing ASCO guidance on MDT management and geriatric assessment, plus Expert Panel survey feedback, resulted in modifications to two existing standards and the addition of four new standards.</p><p><strong>Standards: </strong>2025 OMH Standards are provided. The Standards support quality oncology care delivery in the areas of patient engagement, availability and access to care, evidence-based medicine, comprehensive team-based care, quality improvement, goals of care, palliative and end-of-life care discussions, and safe antineoplastic therapy administration.Additional information, including the Standards implementation manual, is available at: www.asco.org/standards.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500498"},"PeriodicalIF":4.7,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Practice Recommendations for Myelofibrosis Management in the Asia-Pacific Region: The APAC-MF Alliance.","authors":"Keita Kirito, Chul Won Choi, Than Hein, Hsin-An Hou, Chul Won Jung, Yok-Lam Kwong, Garret M K Leung, Melissa G M Ooi, Ponlapat Rojnuckarin, David M Ross, Lee-Yung Shih, Katsuto Takenaka, Winnie Z Y Teo, Harinder Gill","doi":"10.1200/OP-24-00916","DOIUrl":"https://doi.org/10.1200/OP-24-00916","url":null,"abstract":"<p><strong>Purpose: </strong>Myelofibrosis (MF) is a complex and clinically heterogeneous myeloproliferative neoplasm, presenting significant challenges for patient care and clinical decision making. Although global guidelines exist for MF management and continue to evolve with the advent of novel therapies, they do not consider regional variations in drug accessibility nor the availability of diagnostic tools and resources. The notable gap in regional guidance for managing patients with MF in the Asia-Pacific (APAC) region has led to regional disparities in patient care practices. To bridge this gap, a steering committee (SC) of 14 expert hematologists from the APAC region collaborated to develop evidence- and consensus-based consensus statements (CSs) for MF management in the APAC region.</p><p><strong>Materials and methods: </strong>On the basis of evidence from a systematic literature review and their own clinical experience, the SC drafted 13 clinical practice recommendations across four consensus themes: (1) defining the thresholds for anemia and when to initiate or modify treatment; (2) defining when to initiate or modify treatment for thrombocytopenia; (3) defining Janus kinase inhibitor failure and what would warrant switching treatment; and (4) defining the most appropriate risk stratification model for MF in the APAC region. The SC and an extended faculty (EF) of 47 hematologists and two patients voted on the CSs in a modified Delphi process using a 9-point scale (1 = strongly disagree, 9 = strongly agree), with consensus achieved when 75% agreed within the range of 7-9.</p><p><strong>Results: </strong>Following amendments to align with EF feedback, consensus was achieved for all 13 CSs.</p><p><strong>Conclusion: </strong>These CSs offer pragmatic guidance tailored to the MF landscape in the APAC region, which aims to enhance the quality of patient care and outcomes. The CSs in this study are formally endorsed by the Asian Myeloid Working Group.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2400916"},"PeriodicalIF":4.7,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of Quality Improvement Interventions in Medical Oncology: A Systematic Review.","authors":"Georgia Zachou, Sukumar S Sugeeta, Joanna Dodkins, Adil Rashid, Julie Nossiter, Agnieszka Michael, Julie Gralow, Ajay Aggarwal","doi":"10.1200/OP-25-00289","DOIUrl":"https://doi.org/10.1200/OP-25-00289","url":null,"abstract":"<p><strong>Purpose: </strong>As global cancer rates rise, the demand for effective, high-quality delivery of systemic anticancer therapy (SACT) is crucial. However, quality improvement (QI) research in medical oncology remains limited. This systematic review aims to identify and characterize QI interventions addressing quality deficits in medical oncology practice, focusing on intervention types, methodologies, and outcomes.</p><p><strong>Methods: </strong>A systematic search of EMBASE and MEDLINE was conducted from January 2000 to November 2024, following PRISMA guidelines (PROSPERO: CRD42024579992). Studies were included if they evaluated a QI intervention in medical oncology using a baseline measurement and aiming to address a predefined quality deficit in patient-related outcomes. Data on study design, intervention types, quality deficits, and outcomes were extracted, and study quality was assessed using the QI Minimum Quality Criteria Set (QI-MQCS).</p><p><strong>Results: </strong>Of the 11,655 studies identified, 28 met the inclusion criteria. Five key themes emerged: waiting times for SACT delivery at infusion visits, delays in commencement of initial SACT, optimal utilization of SACT, side effects of SACT, and safety. Most studies were conducted in the United States (n = 17), at a single center (n = 27) with only one national-level study. Funding was reported in three studies (two industry-sponsored, one philanthropic). All studies demonstrated a positive impact on at least one patient-related outcome measure. QI-MQCS scores ranged from 11 to 16 of 16.</p><p><strong>Conclusion: </strong>Although cancer treatment continues to evolve, QI strategies in medical oncology remain underexplored. While all identified interventions were beneficial, generalizability is limited by single-center settings and methodological constraints. Expansion of QI research beyond the United States, adoption of stronger study designs, and increased investment in QI training and infrastructure are needed. Multilevel support and sustainable funding are essential to scale up evidence-based QI efforts and improve oncology care globally.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500289"},"PeriodicalIF":4.7,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Breast Cancer in the Middle East and North Africa: Economic Burden, Market Trends, and Care Challenges.","authors":"Radwa Ahmed Batran, Sara Tahoun, Lama Helmy, Ayman Bahr, Ahmed Khalil, Mohab Kamel, Mohamed Elsokary","doi":"10.1200/OP-25-00354","DOIUrl":"https://doi.org/10.1200/OP-25-00354","url":null,"abstract":"<p><p>Breast cancer remains a critical global health challenge, with a high incidence rate and significant mortality. In 2022, it was the second most diagnosed cancer worldwide and ranked as the fourth leading cause of cancer-related deaths. The Middle East and North Africa (MENA) region faces considerable challenges in managing this burden. Among all WHO regions, MENA is projected to experience the highest increase in cancer cases over the coming decades, primarily because of population growth, aging, and lifestyle changes. Extensive analyses of the Global Burden of Disease Study 2019 have revealed a near doubling of breast cancer incidence and prevalence across MENA countries between 1990 and 2019, accompanied by a threefold increase in related mortality. The region also faces unique challenges, including late-stage diagnosis, limited access to advanced diagnostic and therapeutic options, disparities in health care infrastructure, and financial constraints affecting treatment accessibility. This review aims to provide a comprehensive overview of the economic burden of breast cancer in MENA, exploring key market trends and growth drivers in both the diagnostics and therapeutics sectors. It also highlights various national initiatives implemented to address the growing burden of breast cancer and outlines recommendations to bridge existing gaps, enhance early detection, improve treatment outcomes, and strengthen health care systems to better manage the disease in the region.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500354"},"PeriodicalIF":4.7,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends of Authors' Conflicts of Interest in Clinical Trials Published in the <i>Journal of Clinical Oncology</i>: A Large Language Model-Assisted Longitudinal Study.","authors":"Jiasheng Wang, Pedro C Silberman, Sayan Mullick Chowdhury, Bradley W Blaser","doi":"10.1200/OP-25-00293","DOIUrl":"https://doi.org/10.1200/OP-25-00293","url":null,"abstract":"<p><strong>Purpose: </strong>Conflicts of interest (COIs) between clinical trial investigators and biopharmaceutical companies have raised concerns about potential bias in research. This study aimed to systematically analyze the prevalence and trends of COIs in oncology clinical trials published in the <i>Journal of Clinical Oncology</i> (JCO) for the past 15 years and to demonstrate the utility of large language models (LLMs) for automated data extraction in this context.</p><p><strong>Methods: </strong>We identified clinical trials published in the JCO from 2010 to 2025 using PubMed. We extracted publication data and author disclosures from the JCO Web site. OpenAI's GPT-4o was used to identify the main medical product studied and the related biopharmaceutical company and their variants in author disclosures. We then analyzed COI trends across three time periods (2010-2015, 2015-2020, 2020-2025).</p><p><strong>Results: </strong>GPT-4o demonstrated close to 95% accuracy in identifying medical products and companies. Of the 2,583 clinical trials, 2,219 (85.9%) involved a medical product. Among these, 1,610 (72.6%) had at least one author with a COI related to the associated biopharmaceutical company. COI prevalence increased from 70.0% (2010-2015) to 77.0% (2015-2020), and then decreased to 72.0% (2020-2025). Company employment, advisory roles, and honoraria were common COI types and followed similar trends. US-led studies had a significantly higher COI prevalence than those from other regions (77.6% <i>v</i> 67.3%; <i>P</i> < .001). Additionally, 61.9% of first or last authors had a COI, which increased consistently over three time periods.</p><p><strong>Conclusion: </strong>This study reveals widespread COIs in oncology clinical trials, particularly in US-led studies and among leading authors, with discernible temporal patterns. The LLM-based method provides an efficient solution for COI monitoring, promoting transparency in biomedical research.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500293"},"PeriodicalIF":4.7,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cancer Screening, Diagnosis, and Treatment for Vulnerable Patients Incarcerated in US Prisons.","authors":"Christopher R Manz, Brett Nava-Coulter, Emma Voligny, Daniel A Gundersen, Alexi A Wright","doi":"10.1200/OP-25-00361","DOIUrl":"https://doi.org/10.1200/OP-25-00361","url":null,"abstract":"<p><strong>Purpose: </strong>Cancer is the leading cause of death in US prisons, where incarcerated patients have substantially worse survival than nonincarcerated patients. Yet, cancer care delivery in US prisons has not been well described. This study describes cancer care delivery across the cancer continuum for individuals incarcerated in US prisons.</p><p><strong>Methods: </strong>Semistructured interviews were conducted with 32 prison medical directors, primary care clinicians (PCPs), and oncologists caring for patients with cancer incarcerated in 16 US state and federal prison systems between September 2023 and April 2024. A member-checking focus group of 22 prison medical directors and clinicians was held in February 2025.</p><p><strong>Results: </strong>Interview participants included nine prison medical directors, six PCPs, one gynecologist, 15 oncologists, and one palliative care clinician. Themes identified distinct logistics related to screening, diagnosis, treatment, symptom management, survivorship, and end-of-life care, and several cross-cutting topics including communication, scheduling, community transitions, and payment models. Participants reported that screening is widely available for some but not all cancers in prison. Prison clinicians and staff manage most screening and diagnostic evaluations, which require lengthy, sequential approval processes. Radiographic imaging, procedures, surgery, and treatment usually occur outside of prisons. Prison primary care teams manage many tasks usually overseen by oncology teams, including scheduling, care coordination, and management of symptoms from cancer and treatment. Policies limit clinician communication and family involvement, with important care ramifications. Security requirements and staff shortages complicate care coordination and scheduling. The focus group reinforced these themes and did not identify new themes.</p><p><strong>Conclusion: </strong>The unique and complicated logistics of cancer care for patients incarcerated in US prisons differ from care provided to nonincarcerated patients and may negatively affect their cancer outcomes.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500361"},"PeriodicalIF":4.7,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Subcutaneous Immunotherapies in Solid Tumors: Are We Truly Expanding Access and Efficiency?","authors":"Gogo-Ogute Ibodeng, Chelsee Jensen, Scott A Soefje, Aakash Desai","doi":"10.1200/OP-25-00052","DOIUrl":"https://doi.org/10.1200/OP-25-00052","url":null,"abstract":"","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500052"},"PeriodicalIF":4.7,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Performance of Prognostic Models for Advanced Renal Cell Carcinoma in the Era of Improved Survival With Immune Checkpoint Inhibitors.","authors":"Charlene M Mantia, Opeyemi A Jegede, David F McDermott, Daniel Y C Heng, Wanling Xie, Toni K Choueiri, Michael B Atkins, Meredith M Regan","doi":"10.1200/OP-25-00089","DOIUrl":"10.1200/OP-25-00089","url":null,"abstract":"<p><strong>Purpose: </strong>In the era of prolonged survival for advanced renal cell carcinoma (aRCC) with standard-of-care first-line therapy now including immune checkpoint inhibitor, re-evaluation of the Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic RCC Database Consortium (IMDC) prognostic models is overdue.</p><p><strong>Methods: </strong>Data from 1,052 patients with aRCC treated on the CheckMate-214 phase III randomized trial with first-line nivolumab + ipilimumab or sunitinib were analyzed after minimum 5 years of follow-up. The end point was overall survival (OS). To investigate long-term prognostication with each treatment approach, model performance based upon continuous risk score was assessed in a time-dependent manner of increasing 6-month intervals and globally over full follow-up, using discrimination concordance (c)-indices.</p><p><strong>Results: </strong>With time-dependent assessment, the IMDC and MSKCC models maintained their performance over approximately 2 years from sunitinib initiation (c ≥0.69 through 18-24 months); thereafter, the models' performances with long-term OS attenuated. Over full follow-up, the models' discrimination was c = 0.66 (95% CI, 0.658 to 0.664) and c = 0.64 (95% CI, 0.640 to 0.645), respectively, for the sunitinib group. After nivolumab + ipilimumab initiation, the IMDC and MSKCC models' global discrimination was c = 0.63 (95% CI, 0.628 to 0.634) and c = 0.61 (95% CI, 0.607 to 0.614), respectively. The models' performances were attenuated in the short term (c ranging 0.64-0.69 through 18-24 months) and the long term.</p><p><strong>Conclusion: </strong>This retrospective analysis of the CheckMate-214 trial, in which nivolumab + ipilimumab improved survival versus sunitinib with 48% and 37% of patients, respectively, surviving beyond 5 years, confirmed the strength of the models' prognostication for the early years after first-line sunitinib initiation continuing to stratify three prognostic categories, but also diminished discrimination among long-term survivors and with initiation of nivolumab + ipilimumab. As novel treatments are developed and patients with aRCC live longer, new models to estimate long-term prognosis are needed.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500089"},"PeriodicalIF":4.7,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12262164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Screening for Financial Toxicity and Health-Related Social Risks in Patients With GI Cancer: Results From a Large Cancer Center.","authors":"Aditya Narayan, Kaitlyn Lapen, Edward Christopher Dee, Bridgette Thom, Emeline M Aviki, Fumiko Chino","doi":"10.1200/OP-25-00218","DOIUrl":"10.1200/OP-25-00218","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with GI cancers often face significant financial toxicity (FT) and health-related social risks (HRSRs), yet best practices for screening remain unclear. This study aimed to evaluate the prevalence of FT and HRSR and identify associated factors.</p><p><strong>Methods: </strong>From June 2022 to August 2023, patients were screened using the Comprehensive Score for Financial Toxicity (COST), patient-reported HRSR (eg, housing, food insecurity), and quality of life (QOL). Multivariate regressions were used to assess predictors of FT and HRSR, adjusting for several variables.</p><p><strong>Results: </strong>Among 8,335 patients with GI cancer, 45% had a COST score of <26, indicating FT. In adjusted linear regression, FT was associated with racial/ethnic minority status (β, 4.20; <i>P</i> < .001), advanced disease (stage III [β, 1.33; <i>P</i> < .001]; IV [β, 1.56; <i>P</i> < .001]), recent treatment (β, 3.23; <i>P</i> < .001), and anal (β, 1.97; <i>P</i> = .003), esophageal (β, 1.66; <i>P</i> = .005), or hepatobiliary cancer (β, 1.05; <i>P</i> = .031). Older age (≥65 years [β, -5.17; <i>P</i> < .001]), higher income ($100,000-$200,000 [β, -1.81; <i>P</i> < .001]; >$200,000 [β, -3.80; <i>P</i> < .001]), and private insurance (β, -1.70; <i>P</i> < .001) were protective. Twenty-eight percent reported at least one HRSR. HRSRs were associated with minority status (odds ratio [OR], 2.14; <i>P</i> < .001), advanced disease (stage III [OR, 1.31; <i>P</i> = .001]; IV [OR, 1.24; <i>P</i> = .010]), recent treatment (OR, 1.20; <i>P</i> = .001), and gastric cancer (OR, 1.25; <i>P</i> = .027). Lower HRSR was associated with older age (OR, 0.59; <i>P</i> < .001), higher income ($100,000-$200,000 [OR, 0.66; <i>P</i> < .001]; >$200,000 [OR, 0.48; <i>P</i> < .001]), and private insurance (OR, 0.64; <i>P</i> < .001). Sex was not a predictor. Worst FT was associated with decreased QOL (β, -0.98; <i>P</i> < .001) and reduced medication adherence (β, 0.11; <i>P</i> < .001).</p><p><strong>Conclusion: </strong>High levels of FT and HRSR were observed in patients with GI cancer. Early intervention to address financial and social burdens may improve both disease and survivorship outcomes.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500218"},"PeriodicalIF":4.7,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12258957/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Industry Collaboration on US Food and Drug Administration Approval Success in Genitourinary Malignancy Phase III Clinical Trials.","authors":"Kamil Malshy, Matthew Steidle, Trevor C Hunt, Zijing Cheng, Ashley Li, Timothy D Campbell, Jathin Bandari","doi":"10.1200/OP-25-00194","DOIUrl":"https://doi.org/10.1200/OP-25-00194","url":null,"abstract":"<p><strong>Purpose: </strong>Collaboration among trial sponsors can pool expertise and resources, potentially accelerating drug development and regulatory success. This study assessed whether collaborations between drug sponsors influence the likelihood and timing of US Food and Drug Administration (FDA) approval for phase III clinical trials in genitourinary cancers.</p><p><strong>Methods: </strong>We queried ClinicalTrials.gov for all industry-sponsored, interventional phase III trials in genitourinary malignancies completed between January 1, 2010, and October 1, 2024. Trials involving supportive agents, nontherapeutics, or bioequivalence studies were excluded. Eligible trials were grouped by sponsorship structure: single-sponsor (SS) or sponsor-collaborator (S-C). Time to FDA approval was compared using Kaplan-Meier estimates and log-rank tests. Stratified Cox regression assessed the impact of collaboration across subgroups (disease site, stage, and previous drug approval). An additional analysis examined trials that met their primary end points.</p><p><strong>Results: </strong>Seventy-eight trials met inclusion criteria from an initial 183. Of these, 51 (65.4%) were SS trials and 27 (34.6%) were S-C. FDA approval was granted for 20 of 27 S-C trials (74.1%) versus 20 of 51 SS trials (39.2%). S-C trials had significantly faster approval (hazard ratio [HR], 2.75 [95% CI, 1.46 to 5.18]; <i>P</i> = .0009). One- and 2-year approval rates were, respectively, 50.0% and 73.6% for S-C, compared with 19.6% and 31.4% for SS trials. Subgroup analyses confirmed consistent benefits across metastatic disease, prostate cancer, and previously approved drugs. Among the 50 trials that met their primary end points, S-C trials had a higher approval likelihood (HR, 2.23 [95% CI, 1.13 to 4.38]; <i>P</i> = .013).</p><p><strong>Conclusion: </strong>Sponsor collaboration significantly improves FDA approval rates and timelines in phase III genitourinary cancer trials, including those meeting primary end points. This strategy may enhance trial success and accelerate access to new therapies.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":" ","pages":"OP2500194"},"PeriodicalIF":4.7,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}