Journal of Clinical Oncology最新文献

{"title":"Can We Find a Place for Trophoblast Cell Surface Antigen 2-Targeted Antibody-Drug Conjugates in Lung Cancer?","authors":"Alissa J Cooper, Gregory J Riely","doi":"10.1200/JCO-24-01900","DOIUrl":"10.1200/JCO-24-01900","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"241-243"},"PeriodicalIF":42.1,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11735323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142365393","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":"Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study.","authors":"Tycel Jovelle Phillips, Carmelo Carlo-Stella, Franck Morschhauser, Emmanuel Bachy, Michael Crump, Marek Trněný, Nancy L Bartlett, Jan Zaucha, Tomasz Wrobel, Fritz Offner, Kathryn Humphrey, James Relf, Audrey Filézac de L'Etang, David J Carlile, Ben Byrne, Naseer Qayum, Linda Lundberg, Michael Dickinson","doi":"10.1200/JCO.23.02470","DOIUrl":"10.1200/JCO.23.02470","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) have a poor prognosis. The phase I/II NP30179 study (ClinicalTrials.gov identifier: NCT03075696) evaluated glofitamab monotherapy in patients with R/R B-cell lymphomas, with obinutuzumab pretreatment (Gpt) to mitigate the risk of cytokine release syndrome (CRS) with glofitamab. We present data for patients with R/R MCL.</p><p><strong>Methods: </strong>Eligible patients with R/R MCL (at least one previous therapy) received Gpt (1,000 or 2,000 mg) 7 days before the first glofitamab dose (single dose or split over 2 days if required). Glofitamab step-up dosing was administered once a day on days 8 (2.5 mg) and 15 (10 mg) of cycle 1, with a target dose of 16 or 30 mg once every 3 weeks from cycle 2 day 1 onward, for 12 cycles. Efficacy end points included investigator-assessed complete response (CR) rate, overall response rate (ORR), and duration of CR.</p><p><strong>Results: </strong>Of 61 enrolled patients, 60 were evaluable for safety and efficacy. Patients had received a median of two previous therapies (range, 1-5). CR rate and ORR were 78.3% (95% CI, 65.8 to 87.9) and 85.0% (95% CI, 73.4 to 92.9), respectively. In patients who had received previous treatment with a Bruton tyrosine kinase inhibitor (n = 31), CR rate was 71.0% (95% CI, 52.0 to 85.8) and ORR was 74.2% (95% CI, 55.4 to 88.1). CRS after glofitamab administration occurred in 70.0% of patients, with a lower incidence in the 2,000 mg (63.6% [grade ≥2, 22.7%]) versus 1,000 mg (87.5%; grade ≥2, 62.5%) Gpt cohort. Four adverse events led to glofitamab withdrawal (all infections).</p><p><strong>Conclusion: </strong>Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"318-328"},"PeriodicalIF":42.1,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11771347/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375491","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":"Inferior Control Arms in Prostate Cancer Trials: The ARANOTE Trial.","authors":"Abhenil Mittal, Geordie Linford, Bishal Gyawali","doi":"10.1200/JCO-24-02314","DOIUrl":"https://doi.org/10.1200/JCO-24-02314","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402314"},"PeriodicalIF":42.1,"publicationDate":"2025-01-17","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":"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":"https://doi.org/10.1200/JCO-24-02742","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402742"},"PeriodicalIF":42.1,"publicationDate":"2025-01-17","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":"Clonal Hematopoiesis in Women With Breast Cancer.","authors":"Christina Mayerhofer, Rachel A Freedman, Heather A Parsons, Ann H Partridge, Peter G Miller","doi":"10.1200/JCO-24-01848","DOIUrl":"https://doi.org/10.1200/JCO-24-01848","url":null,"abstract":"<p><strong>Purpose: </strong>Clonal hematopoiesis (CH) has been associated with a variety of adverse outcomes, most notably hematologic malignancy and ischemic cardiovascular disease. A series of recent studies also suggest that CH may play a role in the outcomes of patients with solid tumors, including breast cancer. Here, we review the clinical and biological data that underlie potential connections between CH, inflammation, and breast cancer, with a focus on the prevalence and impact of clonal hematopoiesis of indeterminate potential in patients with breast cancer.</p><p><strong>Methods: </strong>We summarize data from multiple studies, including a series of cohorts of patients with breast cancer, to assess the prevalence of CH, the relationship between CH and exposure to cytotoxic therapy, and the correlation between CH and breast cancer-specific outcomes.</p><p><strong>Results: </strong>Our findings indicate that CH is prevalent among patients with breast cancer, particularly those treated with cytotoxic therapies. However, there are no definitive data to support an association between the presence of CH and breast cancer-specific outcomes.</p><p><strong>Conclusion: </strong>Current data do not support routine CH testing in patients with breast cancer, nor should the presence of CH influence decisions regarding breast cancer therapy in most patients. However, larger, long-term studies are necessary to further define the implications of CH in patients with breast cancer and guide clinical decision making.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401848"},"PeriodicalIF":42.1,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006120","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 the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials.","authors":"Jia Liu, Max Farrow, Lesley Seymour, Jayesh Desai, Herbert H Loong, Percy Ivy, Takafumi Koyoma, Natalie Cook, Sarah Blagden, Elena Garralda, Christophe Massard, Anthony W Tolcher, Jacob J Adashek, Li Zhang, Shen Zhao, Lin Shen, Razelle Kurzrock, Wafik S El-Deiry, Vivek Subbiah, Anthony M Joshua","doi":"10.1200/JCO-24-01534","DOIUrl":"https://doi.org/10.1200/JCO-24-01534","url":null,"abstract":"<p><strong>Purpose: </strong>Over the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner. Networks and consortia may overcome some of these challenges of enrolling suitable patients and streamlining start-up, particularly when distance and disease trajectory come into play.</p><p><strong>Design: </strong>In this article, we provide an overview of EPCT consortia in adult oncology across different continents assembled through systematic review of the literature and snowball sampling methodology. We illustrate their scope, structure, funding, and achievements.</p><p><strong>Results: </strong>Fifteen EPCT consortia were identified including two in the United States, three in Europe, five in Asia-Pacific, two intercontinental consortia, and three within private oncology networks. These consortia vary in their scope, funding, and structure from government-funded models such as the National Cancer Institute Experimental Therapeutics Clinical Trials Networks through charitably funded and private research organizations. EPCT consortia play a role in collaborative research, molecular tumor boards to provide patient-centric biomarker-matched treatments, and streamlining trial conduct to improve timelines and cost efficiency.</p><p><strong>Conclusion: </strong>The growth in EPCT activity and complexity has resulted in expansion in the number of EPCT consortia globally. By actively engaging with regulatory bodies and pharmaceutical and contract research organization industries, consortia have an opportunity to address the evolving challenges faced in this field and to accelerate the translation of scientific discoveries into clinical practice.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401534"},"PeriodicalIF":42.1,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983631","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":"Randomized Comparison of Magnetic Resonance Imaging Versus Transurethral Resection for Staging New Bladder Cancers: Results From the Prospective BladderPath Trial","authors":"Richard T. Bryan, Wenyu Liu, Sarah J. Pirrie, Rashid Amir, Jean Gallagher, Ana I. Hughes, Kieran P. Jefferson, Allen Knight, Veronica Nanton, Harriet P. Mintz, Ann M. Pope, Jacob Cherian, Kingsley Ekwueme, Lyndon Gommersall, Giles Hellawell, Paul Hunter-Campbell, Gokul Kanda Swamy, Sanjeev Kotwal, Vivekanandan Kumar, David Mak, Amar Mohee, Thiagarajan Nambirajan, Douglas G. Ward, Steven J. Kennish, James W.F. Catto, Prashant Patel, and Nicholas D. James","doi":"10.1200/jco.23.02398","DOIUrl":"https://doi.org/10.1200/jco.23.02398","url":null,"abstract":"&lt;section id=\"abs-sec-1\" style=\"box-sizing: border-box; color: rgb(51, 51, 51); font-family: -apple-system, BlinkMacSystemFont, &quot;Segoe UI&quot;, Roboto, &quot;Helvetica Neue&quot;, Arial, &quot;Noto Sans&quot;, sans-serif, &quot;Apple Color Emoji&quot;, &quot;Segoe UI Emoji&quot;, &quot;Segoe UI Symbol&quot;, &quot;Noto Color Emoji&quot;; letter-spacing: 0.32px; text-wrap-mode: wrap;\"&gt;&lt;h3 style=\"box-sizing: border-box; margin: 1rem 0px; line-height: 1.875rem; font-size: 1.25rem; color: rgb(11, 11, 11);\"&gt;&lt;span style=\"font-family: arial, helvetica, sans-serif;\"&gt;Purpose&lt;/span&gt;&lt;/h3&gt;&lt;p&gt;&lt;span style=\"font-family: arial, helvetica, sans-serif;\"&gt;Transurethral resection of bladder tumor (TURBT) is the initial staging procedure for new bladder cancers (BCs). For muscle-invasive bladder cancers (MIBCs), TURBT may delay definitive treatment. We investigated whether definitive treatment can be expedited for MIBC using flexible cystoscopic biopsy and multiparametric magnetic resonance imaging (mpMRI) for initial staging.&lt;/span&gt;&lt;/p&gt;&lt;/section&gt;&lt;p&gt;&lt;section id=\"abs-sec-2\" style=\"box-sizing: border-box; color: rgb(51, 51, 51); font-family: -apple-system, BlinkMacSystemFont, &quot;Segoe UI&quot;, Roboto, &quot;Helvetica Neue&quot;, Arial, &quot;Noto Sans&quot;, sans-serif, &quot;Apple Color Emoji&quot;, &quot;Segoe UI Emoji&quot;, &quot;Segoe UI Symbol&quot;, &quot;Noto Color Emoji&quot;; letter-spacing: 0.32px; text-wrap-mode: wrap;\"&gt;&lt;h3 style=\"box-sizing: border-box; margin: 1rem 0px; line-height: 1.875rem; font-size: 1.25rem; color: rgb(11, 11, 11);\"&gt;&lt;span style=\"font-family: arial, helvetica, sans-serif;\"&gt;Patients and Methods&lt;/span&gt;&lt;/h3&gt;&lt;p&gt;&lt;span style=\"font-family: arial, helvetica, sans-serif;\"&gt;We conducted a prospective open-label, randomized study conducted within 17 UK hospitals (registered as ISRCTN 35296862). Participants with suspected new BC were randomly assigned 1:1 to TURBT-staged or mpMRI-staged care, with minimization factors of sex, age, and clinician visual assessment of stage. Blinding was not possible. Patients unable/unwilling to undergo mpMRI or with previous BC were ineligible. The study had two stages with separate primary outcomes of feasibility and time to correct treatment (TTCT) for MIBC, respectively.&lt;/span&gt;&lt;/p&gt;&lt;/section&gt;&lt;section id=\"abs-sec-3\" style=\"box-sizing: border-box; color: rgb(51, 51, 51); font-family: -apple-system, BlinkMacSystemFont, &quot;Segoe UI&quot;, Roboto, &quot;Helvetica Neue&quot;, Arial, &quot;Noto Sans&quot;, sans-serif, &quot;Apple Color Emoji&quot;, &quot;Segoe UI Emoji&quot;, &quot;Segoe UI Symbol&quot;, &quot;Noto Color Emoji&quot;; letter-spacing: 0.32px; text-wrap-mode: wrap;\"&gt;&lt;h3 style=\"box-sizing: border-box; margin: 1rem 0px; line-height: 1.875rem; font-size: 1.25rem; color: rgb(11, 11, 11);\"&gt;&lt;span style=\"font-family: arial, helvetica, sans-serif;\"&gt;Results&lt;/span&gt;&lt;/h3&gt;&lt;p&gt;&lt;span style=\"font-family: arial, helvetica, sans-serif;\"&gt;Between May 31, 2018, and December 31, 2021, 638 patients were screened, and 1","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"49 1","pages":""},"PeriodicalIF":45.3,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142981937","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: Concerns on Potential Risk of Roxadustat in Promoting Tumor Progression: Double-Edged Sword of Hypoxia-Inducible Factor-1α Activation.","authors":"George M Rodgers, Jeffrey A Gilreath","doi":"10.1200/JCO-24-02610","DOIUrl":"https://doi.org/10.1200/JCO-24-02610","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402610"},"PeriodicalIF":42.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142978522","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":"https://doi.org/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":"JCO2401441"},"PeriodicalIF":42.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chimeric Antigen Receptor-T Cells in Colorectal Cancer: Pioneering New Avenues in Solid Tumor Immunotherapy.","authors":"Shaida Ouladan, Elias Orouji","doi":"10.1200/JCO-24-02081","DOIUrl":"https://doi.org/10.1200/JCO-24-02081","url":null,"abstract":"<p><p>Colorectal cancer (CRC) remains a major global health burden, being one of the most prevalent cancers with high mortality rates. Despite advances in conventional treatment modalities, patients with metastatic CRC often face limited options and poor outcomes. Chimeric antigen receptor-T (CAR-T) cell therapy, initially successful in hematologic malignancies, presents a promising avenue for treating solid tumors, including CRC. This review explores the potential of CAR-T cell therapy in CRC by analyzing clinical trials and highlighting prominent CRC-specific targets. We discuss the challenges such as immunosuppressive microenvironment, tumor heterogeneity, and physical barriers that limit CAR-T efficacy. Emerging strategies, such as logic-gated and dual-targeting CAR-T cells, offer practical solutions to overcome these hurdles. Furthermore, we explore the combination of CAR-T cell therapy with immune checkpoint inhibitors to enhance T-cell persistence and tumor infiltration. As the field continues to evolve, CAR-T cell therapies hold significant potential for revolutionizing the treatment landscape of CRC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402081"},"PeriodicalIF":42.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142978596","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}