Journal of Clinical Oncology最新文献

{"title":"Inferior Control Arms in Prostate Cancer Trials: The ARANOTE Trial.","authors":"Abhenil Mittal, Geordie Linford, Bishal Gyawali","doi":"10.1200/JCO-24-02314","DOIUrl":"10.1200/JCO-24-02314","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1393-1394"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Accelerating Myeloma Drug Development: Will Minimal Residual Disease Replace Progression-Free Survival as an Intermediate Surrogate End Point?","authors":"María-Victoria Mateos, Noemí Puig","doi":"10.1200/JCO-25-00048","DOIUrl":"10.1200/JCO-25-00048","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1271-1274"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: First-Line Nivolumab Plus Relatlimab Versus Nivolumab Plus Ipilimumab in Advanced Melanoma: An Indirect Treatment Comparison Using RELATIVITY-047 and CheckMate 067 Trial Data.","authors":"Georgina V Long, Evan J Lipson, F Stephen Hodi, Paolo A Ascierto, James Larkin, Christopher Lao, Jean-Jacques Grob, Flavia Ejzykowicz, Andriy Moshyk, Viviana Garcia-Horton, Zheng-Yi Zhou, Yiqiao Xin, Jennell Palaia, Laura McDonald, Sarah Keidel, Anthony Salvatore, Divya Patel, Leon A Sakkal, Hussein Tawbi, Dirk Schadendorf","doi":"10.1200/JCO-25-00452","DOIUrl":"10.1200/JCO-25-00452","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1398"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143575651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Supervised Exercise for Patients With Metastatic Breast Cancer: A Cost-Utility Analysis Alongside the PREFERABLE-EFFECT Randomized Controlled Trial.","authors":"Aniek E M Schouten, Anouk E Hiensch, Geert W J Frederix, Evelyn M Monninkhof, Martina E Schmidt, Dorothea Clauss, Nadira Gunasekara, Jon Belloso, Mark Trevaskis, Helene Rundqvist, Joachim Wiskemann, Jana Müller, Maike G Sweegers, Carlo Fremd, Renske Altena, Rhodé M Bijlsma, Gabe Sonke, Ainhara Lahuerta, G Bruce Mann, Prudence A Francis, Gary Richardson, Wolfram Malter, Joanna Kufel-Grabowska, Elsken van der Wall, Neil K Aaronson, Elzbieta Senkus, Ander Urruticoechea, Eva M Zopf, Wilhelm Bloch, Martijn M Stuiver, Yvonne Wengstrom, Karen Steindorf, Miriam P van der Meulen, Anne M May","doi":"10.1200/JCO-24-01441","DOIUrl":"10.1200/JCO-24-01441","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the cost utility of a 9-month supervised exercise program for patients with metastatic breast cancer (mBC), compared with control (usual care, supplemented with general activity advice and an activity tracker). Evidence on the cost-effectiveness of exercise for patients with mBC is essential for implementation in clinical practice and is currently lacking.</p><p><strong>Methods: </strong>A cost-utility analysis was performed alongside the multinational PREFERABLE-EFFECT randomized controlled trial, conducted in 8 centers across Europe and Australia. Patients with mBC (N = 357) were randomly assigned to either a 9-month, twice-weekly, supervised exercise group (EG) or control group (CG). Costs of the exercise program were calculated through a bottom-up approach. Other health care resource use, productivity losses, and quality of life were collected using country-adapted, self-reported questionnaires. Analyses were conducted from a societal perspective with a time horizon of 9 months. Costs were collected and reported in 2021 Euros (€1 = $1.18 US dollars).</p><p><strong>Results: </strong>Compared with the CG, EG resulted in a quality-adjusted life-year (QALY) gain of 0.013 (95% CI, -0.02 to 0.05) over a 9-month period. The mean costs of the exercise program were €1,696 per patient with one-on-one supervision (scenario 1) and €609 with one-on-four supervision (scenario 2). These costs were offset by savings in health care and productivity costs, resulting in mean total cost differences of -€163 (scenario 1) and -€1,249 (scenario 2) in favor of EG. The probability of supervised exercise being cost-effective was 65% in scenario 1 and 91% in scenario 2 at a willingness-to-pay threshold of €20,000 per QALY.</p><p><strong>Conclusion: </strong>Exercise for patients with mBC increases quality of life, decreases costs, and is likely to be cost-effective. Group-based supervision is expected to have even higher cost-savings. Our positive findings can inform reimbursement of supervised exercise interventions for patients with mBC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1325-1336"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11974635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142978525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Botensilimab (Fc-enhanced anti-cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti-PD-1 antibody) in Patients With Relapsed/Refractory Metastatic Sarcomas.","authors":"Breelyn A Wilky, Gary K Schwartz, Michael S Gordon, Anthony B El-Khoueiry, Andrea J Bullock, Brian Henick, Mark Agulnik, Arun Singh, Daruka Mahadevan, Justin Stebbing, Chloe Delepine, Dhan Chand, Manushak Avagyan, Wei Wu, Benny Johnson, Joseph E Grossman, Steven O'Day, Jonathan C Trent, Robin L Jones, Apostolia M Tsimberidou","doi":"10.1200/JCO-24-02524","DOIUrl":"10.1200/JCO-24-02524","url":null,"abstract":"<p><strong>Purpose: </strong>Outcomes for patients with advanced sarcomas are poor and there is a high unmet need to develop novel therapies. The purpose of this phase I study was to define the safety and efficacy of botensilimab (BOT), an Fc-enhanced anti-cytotoxic lymphocyte-association protein-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, in advanced sarcomas.</p><p><strong>Methods: </strong>BOT was administered intravenously (IV) at 1 mg/kg or 2 mg/kg once every 6 weeks in combination with BAL IV at 3 mg/kg once every 2 weeks for up to 2 years. The primary end point was to determine dose-limiting toxicities during the dose-escalation period. Secondary end points include objective response rate (ORR), duration of response (DOR), disease control rate, and progression-free survival (PFS) by RECIST 1.1. Exploratory end points include assessing patient biomarkers including tumor mutational burden, cytokines, and PD-L1 expression.</p><p><strong>Results: </strong>Overall, 64 patients with sarcoma were treated; all were evaluable for safety and 52 for efficacy. The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. No grade 4 or 5 TRAEs were reported. For all evaluable patients, ORR was 19.2% (95% CI, 9.6 to 32.5), and 27.8% (95% CI, 9.7 to 53.5) for evaluable patients with angiosarcoma (n = 18); 33.3% in visceral and 22.2% in cutaneous subtypes. Median PFS for evaluable patients was 4.4 months (95% CI, 2.8 to 6.1), with a 6-month PFS rate of 36% (95% CI, 22 to 50) and a median DOR of 21.7 months (95% CI, 1.9 to not reached).</p><p><strong>Conclusion: </strong>The combination of BOT/BAL demonstrated promising efficacy and safety in a large cohort of heavily pretreated sarcoma patients. This encouraging activity warrants further investigation (ClinicalTrials.gov identifier: NCT03860272).</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1358-1368"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11974637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lessons From Taxanes Versus Eribulin for First-Line Metastatic Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the EMERALD Study.","authors":"Tess A O'Meara, Paolo Tarantino","doi":"10.1200/JCO-24-02717","DOIUrl":"10.1200/JCO-24-02717","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1275-1278"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transoral Robotic Surgery in the Multidisciplinary Care of Patients With Oropharyngeal Squamous Cell Carcinoma: ASCO Guideline.","authors":"F Christopher Holsinger, Nofisat Ismaila, Douglas R Adkins, Brittany R Barber, Graham Burnette, Carole Fakhry, Thomas J Galloway, Ryan P Goepfert, Brett A Miles, Vinidh Paleri, Ashish A Patel, Scott A Roof, Heather M Starmer, Sue S Yom, Nabil F Saba, Ryan Li, Jamie A Ku","doi":"10.1200/JCO-24-02755","DOIUrl":"10.1200/JCO-24-02755","url":null,"abstract":"<p><strong>Purpose: </strong>To provide evidence-based recommendations for the use of transoral robotic surgery (TORS) in the multidisciplinary management of oropharyngeal squamous cell cancer (OPC).</p><p><strong>Methods: </strong>ASCO convened a multidisciplinary Expert Panel to evaluate the evidence and formulate recommendations. The literature search included studies published between January 1, 2002, and August 31, 2024, and comprised systematic reviews, meta-analyses, randomized controlled trials, and observational studies. Outcomes of interest include overall and disease-free survival, functional outcomes, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations.</p><p><strong>Results: </strong>A total of 58 publications were identified to inform the evidence base for this guideline.</p><p><strong>Recommendations: </strong>Evidence-based recommendations address the evaluation and workup of patients with human papillomavirus (HPV)-positive OPC, the role of TORS, patient selection, adjuvant therapy, HPV-negative OPC, and use of TORS in salvage or recurrent setting.Additional information is available at www.asco.org/head-neck-cancer-guidelines.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1369-1392"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Minimal Residual Disease-Based End Point for Accelerated Assessment of Clinical Trials in Multiple Myeloma: A Pooled Analysis of Individual Patient Data From Multiple Randomized Trials.","authors":"Qian Shi, Bruno Paiva, Levi D Pederson, Natalie Dimier, Ela Talpes, Thomas J Prior, Alberto Orfao, Philippe Moreau, Pieter Sonneveld, Shaji K Kumar, Jesse G Dixon, Reshma Patel, Blake J Bartlett, Jordan Schecter, Phillip McCarthy, Dirk Hose, Anja Seckinger, D'Agostino Mattia, Hartmut Goldschmidt, Stefania Oliva, Roger G Owen, Kenneth C Anderson, Jesús San-Miguel, Brian G M Durie, Nikhil Munshi","doi":"10.1200/JCO-24-02020","DOIUrl":"10.1200/JCO-24-02020","url":null,"abstract":"<p><strong>Purpose: </strong>Newly approved drugs and combinations treating multiple myeloma (MM) have resulted in substantial improvements in patients' survival. To deliver rapid access to newer therapies, an earlier end point to expedite clinical trials is needed. Our objective was to evaluate the minimal residual disease-negative complete response (MRD-CR) as an intermediate end point for progression-free survival (PFS) and overall survival (OS) in newly diagnosed (ND) transplant-eligible (NDTE) patients, ND transplant-ineligible (NDTinE) patients, and patients with relapsed/refractory (RR) MM.</p><p><strong>Patients and methods: </strong>Individual patient data from 20 randomized multicenter trials were collected. Eleven studies (4,773 patients) with sufficient data were analyzed to evaluate whether 9- or 12-month MRD-CR classified at a 10^-5 threshold could be reasonably likely to predict the clinical benefit of new agents regarding PFS and OS. Global odds ratio (OR) was estimated using the bivariate Plackett Copula model. Supportive evaluation included correlations of the treatment effects on MRD-CR end points and PFS/OS, evaluated by both linear regression (<i>R</i>²_{weighted least squared}) and Copula (<i>R</i>²_Copula) models.</p><p><strong>Results: </strong>The analysis demonstrated that both 9- and 12-month MRD-CR strongly correlated with PFS at patient level in NDTE patients, NDTinE patients, and patients with RRMM. Global ORs ranged from 3.06 to 16.24, all with 95% CIs excluding 1.0. Encouraging trial-level correlations (<i>R</i>², 0.61-0.70) were observed by pooling three populations and were stronger (<i>R</i>², 0.67-0.78) in the ND population. Similar results were observed for OS.</p><p><strong>Conclusion: </strong>Our findings provided the support for use of MRD-CR classified at a 10^-5 threshold at either 9 or 12 months after starting of the treatment, as an intermediate end point to support accelerated approvals, in future trials in NDTE patients, NDTinE patients, and patients with RRMM.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1289-1301"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143408084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to: Inferior Control Arms in Prostate Cancer Trials: The ARANOTE Trial.","authors":"Fred Saad, Egils Vjaters, Isabella Testa, Kunhi Parambath Haresh","doi":"10.1200/JCO-24-02742","DOIUrl":"10.1200/JCO-24-02742","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1394-1395"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Metronomic Capecitabine Plus Aromatase Inhibitor as Initial Therapy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: The Phase III MECCA Trial.","authors":"Ruo-Xi Hong, Fei Xu, Wen Xia, Yue-E Teng, Qu-Chang Ouyang, Qiu-Fan Zheng, Zhong-Yu Yuan, Dong-Shao Chen, Kui-Kui Jiang, Ying Lin, Zhen Dai, Xin-Lan Liu, Qian-Jun Chen, Xin-Hong Wu, Yan-Xia Shi, Jia-Jia Huang, Xin An, Cong Xue, Xi-Wen Bi, Mei-Ting Chen, Hui Li, He-Rui Yao, Guo-Rong Zou, Heng Huang, Jing-Min Zhang, Shu-Sen Wang","doi":"10.1200/JCO.24.00938","DOIUrl":"10.1200/JCO.24.00938","url":null,"abstract":"<p><strong>Purpose: </strong>The effects of metronomic chemotherapy plus endocrine therapy have yet to be elucidated through a randomized phase III clinical trial.</p><p><strong>Methods: </strong>Randomized clinical trials were conducted at 12 centers in China from August 22, 2017, to September 24, 2021, and the final follow-up date was August 25, 2023. Patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who had no previous systemic therapy in the metastatic setting were enrolled. Participants were 1:1 assigned to receive either metronomic capecitabine plus an aromatase inhibitor (AI) or AI alone. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate, disease control rate (defined as disease controlled for ≥24 weeks), and safety.</p><p><strong>Results: </strong>A total of 263 patients were randomly assigned, among which 254 patients formed the full analysis set. At the median follow-up time of 50.7 months, 203 PFS events occurred. The metronomic capecitabine plus AI arm exhibited a median PFS of 20.9 months compared with 11.9 months in the AI arm (hazard ratio [HR], 0.58 [95% CI, 0.43 to 0.76]). The median OS was not reached in the combination arm and was 45.1 months in the AI arm (HR, 0.58 [95% CI, 0.37 to 0.93]). The most common adverse events were palmar-plantar erythrodysesthesia and peripheral neuropathy; grade 3 events occurred in 15.1% of the patients receiving combination treatment.</p><p><strong>Conclusion: </strong>The MECCA trial demonstrated a significant improvement in PFS and OS with first-line metronomic capecitabine plus AI compared with AI alone in patients with hormone receptor-positive+/HER2-negative MBC. Both treatment arms exhibited tolerable safety profiles consistent with previous reports.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1314-1324"},"PeriodicalIF":42.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11974638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}