Journal of Clinical Oncology最新文献

{"title":"Hyperthermic Intraperitoneal Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: A Randomized Trial on Survival Evaluation (HORSE; MITO-18).","authors":"Anna Fagotti, Barbara Costantini, Francesco Fanfani, Diana Giannarelli, Pierandrea De Iaco, Vito Chiantera, Vincenzo Mandato, Giorgio Giorda, Giovanni Aletti, Stefano Greggi, A Myriam Perrone, Vanda Salutari, Rita Trozzi, Giovanni Scambia","doi":"10.1200/JCO.24.00686","DOIUrl":"10.1200/JCO.24.00686","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to secondary cytoreductive surgery (SCS) without neoadjuvant chemotherapy has a benefit on progression-free survival (PFS), as opposed to SCS alone in patients with platinum-sensitive recurrent epithelial ovarian cancer (platinum-free interval, >6 months).</p><p><strong>Methods: </strong>This was a multicenter randomized phase III study. Random assignment was performed at the time of surgery in cases with residual tumor ≤0.25 cm. HIPEC with cisplatin (CDDP) 75 mg/m² for 60 minutes at 41.5°C was administered at the end of surgery in the experimental arm. Both groups received postoperative platinum-based chemotherapy. The primary end point was PFS. The safety profile and postrecurrence survival (PRS) were the secondary end points.</p><p><strong>Results: </strong>A total of 167 patients underwent random assignment, 82 patients to SCS plus HIPEC (experimental arm) and 85 to SCS alone (control arm). The median follow-up was 83 months (IQR, 64-102). The median PFS was 23 months (95% CI, 17 to 29) in the group that underwent surgery alone and 25 months (95% CI, 18 to 32) in the group that underwent cytoreductive surgery with HIPEC. The probability of PRS at 5 years was 61.6% (95% CI, 50.8 to 72.4) in the SCS group and 75.9% (95% CI, 66.5 to 85.3) in the SCS plus HIPEC group. The incidence of postoperative adverse events of any grade was similar between the two groups.</p><p><strong>Conclusion: </strong>The addition of HIPEC to complete or nearly complete primary SCS did not confer a benefit in terms of PFS in patients with platinum-sensitive peritoneal recurrence.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"852-860"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686994","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":"Withdrawn: Expression of Concern: Dissecting Therapeutic Resistance to RAF Inhibition in Melanoma by Tumor Genomic Profiling.","authors":"","doi":"10.1200/JCO.24.00161","DOIUrl":"10.1200/JCO.24.00161","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"e1"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139940021","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: Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Induction or Consolidation Chemotherapy?","authors":"Amr Aref, Ahmed Abdalla","doi":"10.1200/JCO-25-00095","DOIUrl":"10.1200/JCO-25-00095","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"898"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143032358","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":"Longitudinal Results From the Nationwide Just ASK Initiative to Promote Routine Smoking Assessment in American College of Surgeons-Accredited Cancer Programs.","authors":"Jessica L Burris, Jamie S Ostroff, Eileen M Reilly, Graham W Warren, Rachel C Shelton, Timothy W Mullett","doi":"10.1200/JCO.24.00304","DOIUrl":"10.1200/JCO.24.00304","url":null,"abstract":"<p><strong>Purpose: </strong>Persistent smoking after cancer diagnosis causes adverse outcomes while smoking cessation can improve survival. Thus, integration of smoking assessment and cessation assistance into routine cancer care is critical. Aiming for incremental practice change that could be sustained and built upon through future quality improvement (QI) projects, the American College of Surgeons initiated Just ASK in 2022 to increase implementation of smoking assessment among its accredited Cancer Programs. This manuscript describes outcomes from Just ASK.</p><p><strong>Methods: </strong>Seven hundred sixty-two programs enrolled in this cohort study, followed Plan Do Study Act methodology, and used local QI teams to facilitate practice change. The primary outcome was the ask rate (ie, patients asked/patients seen). Programs completed three surveys across the 1-year study (89.8% retention), answering questions about their program plus organizational readiness, implementation barriers, implementation strategies, and clinical practices related to assessing smoking among patients newly diagnosed with cancer. Data analysis involved descriptive statistics and analysis of change over time (eg, McNemar chi-squares).</p><p><strong>Results: </strong>Programs (53.1% community-based) tended to report moderate organizational readiness, multiple implementation barriers, and adoption of 4.63 ± 1.49 of eight possible implementation strategies (eg, training staff/providers). Programs reported frequency of assessing smoking status, documenting it in the electronic health record, advising patients who smoke to quit, and documenting advice and treatment increased over time (all <i>P</i> < .001). The ask rate increased from baseline to mid to final survey (<i>P</i> < .01; 87.79% <i>v</i> 88.65% <i>v</i> 91.92%, respectively).</p><p><strong>Conclusion: </strong>Just ASK is the latest, and by far the largest, endeavor to improve assessment of cancer patients' smoking status. Participants reported significant advances within a short time span and study results underscore the potential for national accreditation organizations to transform oncology practice.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"821-828"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675951","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":"You Don't Bring Me Flowers.","authors":"Kathryn Cappell","doi":"10.1200/JCO-24-02046","DOIUrl":"10.1200/JCO-24-02046","url":null,"abstract":"<p><p>Dr Cappell discusses the difficulty in protecting oncology patients without taking away things that bring them joy.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"892-893"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059305","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":"High Omega-3, Low Omega-6 Diet With Fish Oil for Men With Prostate Cancer on Active Surveillance: The CAPFISH-3 Randomized Clinical Trial.","authors":"William J Aronson, Tristan Grogan, Pei Liang, Patricia Jardack, Amana R Liddell, Claudia Perez, David Elashoff, Jonathan Said, Pinchas Cohen, Leonard S Marks, Susanne M Henning","doi":"10.1200/JCO.24.00608","DOIUrl":"10.1200/JCO.24.00608","url":null,"abstract":"<p><strong>Purpose: </strong>Men on active surveillance (AS) for prostate cancer are extremely interested in dietary changes or supplements to prevent progression of their disease. We sought to determine whether a high omega-3, low omega-6 fatty acid diet with fish oil capsules (D + FO) decreases proliferation (Ki-67) in prostate biopsies in men with prostate cancer on AS over a 1-year time period.</p><p><strong>Methods: </strong>In this phase II, prospective randomized trial, men (N = 100) with grade group 1 or 2 prostate cancer who elected AS were randomly assigned to the D + FO or a control group. Same-site prostate biopsies were obtained at baseline and 1 year. The primary end point was the change in Ki-67 index from baseline to 1 year from same-site biopsies compared between the groups.</p><p><strong>Results: </strong>The Ki-67 index decreased in the D + FO group by approximately 15% from baseline to 1 year (1.34% at baseline, 1.14% at 1 year) and increased in the control group by approximately 24% from baseline to 1 year (1.23% at baseline, 1.52% at 1 year), resulting in a statistically significant difference in the change of Ki-67 index between the groups (95% CI, 2% to 52%, <i>P</i> = .043). There was no significant difference in the secondary outcomes grade group, tumor length, Decipher genomic score, or prostate-specific antigen between the two groups. Four patients in the D + FO group were withdrawn from the trial because of adverse events related to the FO.</p><p><strong>Conclusion: </strong>A high omega-3, low omega-6 diet with FO for 1 year resulted in a significant reduction in Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death. These findings support future phase III trials incorporating this intervention in men on AS.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"800-809"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869882/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822264","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":"Promises and Challenges of Dietary Intervention in Patients With Prostate Cancer: Lessons Learned From the CAPFISH-3 Trial.","authors":"Nazli Dizman, Andrea Necchi","doi":"10.1200/JCO-24-02444","DOIUrl":"10.1200/JCO-24-02444","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"767-770"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822266","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":"Phase II Study of Acalabrutinib, Venetoclax, and Obinutuzumab in a Treatment-Naïve Chronic Lymphocytic Leukemia Population Enriched for High-Risk Disease.","authors":"Matthew S Davids, Christine E Ryan, Benjamin L Lampson, Yue Ren, Svitlana Tyekucheva, Stacey M Fernandes, Jennifer L Crombie, Austin I Kim, Matthew Weinstock, Josie Montegaard, Heather A Walker, Claire Greenman, Victoria Patterson, Caron A Jacobson, Ann S LaCasce, Philippe Armand, David C Fisher, Steve Lo, Adam J Olszewski, Jon E Arnason, Inhye E Ahn, Jennifer R Brown","doi":"10.1200/JCO-24-02503","DOIUrl":"10.1200/JCO-24-02503","url":null,"abstract":"<p><strong>Purpose: </strong>The AMPLIFY trial recently established fixed-duration acalabrutinib, venetoclax, and obinutuzumab (AVO) as a new standard-of-care option for patients with previously untreated chronic lymphocytic leukemia (CLL) with wild-type <i>TP53</i>; however, due to the chemoimmunotherapy control arm, AMPLIFY excluded patients with high-risk <i>TP53</i> aberration, for whom current standards of care are continuous Bruton tyrosine kinase inhibitor therapy or alternatively fixed-duration venetoclax-based doublets. AVO has not previously been evaluated in patients with CLL with <i>TP53</i> aberration.</p><p><strong>Methods: </strong>This investigator-sponsored, multicenter, phase II study enrolled patients with treatment-naïve CLL enriched for high-risk CLL, defined by <i>TP53</i> aberration (ClinicalTrials.gov identifier: NCT03580928). Patients received acalabrutinib, obinutuzumab, and then venetoclax, with each treatment introduced sequentially and in combination, with the duration guided by measurable residual disease (MRD). Patients who achieved undetectable MRD (uMRD) after either 15 or 24 cycles could discontinue treatment. The primary end point was complete remission (CR) with bone marrow uMRD (BM-uMRD) at the start of cycle 16.</p><p><strong>Results: </strong>Seventy-two patients were accrued, including 45 patients with <i>TP53</i> aberration. The CR with BM-uMRD rates at the start of cycle 16 were 42% in patients with <i>TP53</i> aberration and 42% in all-comers, and the BM-uMRD rates were 71% and 78%, respectively. Hematologic toxicities were mainly low grade, and cardiovascular toxicities and bleeding complications were infrequent. After a median follow-up of 55.2 months, 10 patients had progressed, including four with transformation, and three patients died. Four-year progression-free survival and overall survival for patients with or without <i>TP53</i> aberration were 70%/96% and 88%/100%, respectively.</p><p><strong>Conclusion: </strong>AVO was highly active and well tolerated in patients with previously untreated high-risk CLL, supporting its use as a new standard-of-care treatment option.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"788-799"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791926","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":"Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA.","authors":"Mazyar Shadman, Talha Munir, Tadeusz Robak, Jennifer R Brown, Brad S Kahl, Paolo Ghia, Krzysztof Giannopoulos, Martin Šimkovič, Anders Österborg, Luca Laurenti, Patricia A Walker, Stephen S Opat, Hanna Ciepluch, Richard Greil, Merit Hanna, Monica Tani, Marek Trněný, Danielle Brander, Ian W Flinn, Sebastian Grosicki, Emma Verner, Alessandra Tedeschi, Sophie de Guibert, Gayane Tumyan, Kamel Laribi, José A García-Marco, Jian-Yong Li, Tian Tian, Yu Liu, Roman Korolkiewicz, Andy Szeto, Constantine S Tam, Wojciech Jurczak","doi":"10.1200/JCO-24-02265","DOIUrl":"10.1200/JCO-24-02265","url":null,"abstract":"<p><p><i>Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in</i> JCO <i>or elsewhere, for which the primary end point has already been reported.</i>SEQUOIA (ClinicalTrials.gov identifier: NCT03336333) is a phase III, randomized, open-label trial that compared the oral Bruton tyrosine kinase inhibitor zanubrutinib to bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The initial prespecified analysis (median follow-up, 26.2 months) and subsequent analysis (43.7 months) found superior progression-free survival (PFS; the primary end point) in patients who received zanubrutinib compared with BR. At a median follow-up of 61.2 months, median PFS was not reached in zanubrutinib-treated patients; median PFS was 44.1 months in BR-treated patients (hazard ratio [HR], 0.29; one-sided <i>P</i> = .0001). Prolonged PFS was seen with zanubrutinib versus BR in patients with mutated immunoglobulin heavy-chain variable region (IGHV) genes (HR, 0.40; one-sided <i>P</i> = .0003) and unmutated IGHV genes (HR, 0.21 [95% CI, 0.14 to 0.33]; one-sided <i>P</i> < .0001). Median overall survival (OS) was not reached in either treatment arm; estimated 60-month OS rates were 85.8% and 85.0% in zanubrutinib- and BR-treated patients, respectively. No new safety signals were detected. Adverse events were as expected with zanubrutinib; rate of atrial fibrillation was 7.1%. At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"780-787"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11855994/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794861","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":"Breast, Colorectal, and Pancreatic Cancer Mortality With Pathogenic Variants in <i>ATM</i>, <i>CHEK2</i>, or <i>PALB2</i>.","authors":"Christine M Veenstra, Paul Abrahamse, Ann S Hamilton, Kevin C Ward, Scarlett L Gomez, Lihua Liu, Steven J Katz, Timothy P Hofer, Allison W Kurian","doi":"10.1200/JCO-24-02442","DOIUrl":"10.1200/JCO-24-02442","url":null,"abstract":"<p><strong>Purpose: </strong>Oncologists encounter patients with pathogenic variants (PVs) in <i>ATM</i>, <i>CHEK2</i>, or <i>PALB2</i>, but little is known about their cancer mortality.</p><p><strong>Methods: </strong>Patients who were 20 years or older, diagnosed in 2013-2019 with breast, colorectal, or pancreatic cancer, and reported to SEER registries in California and Georgia were linked to germline genetic testing results from four clinical laboratories and followed through 2021. Multivariable models of cancer mortality were fit; for each cancer, the reference group was the average hazard across all genetically tested patients with that diagnosis. Each cancer was modeled separately, followed by a single model that interacted the cancer type with all covariates. In addition to fixed effects models, random effects models were used as a regularization approach to reduce overfitting.</p><p><strong>Results: </strong>A total of 70,272 tested patients with breast (48,473 estrogen receptor-/progesterone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative; 9,957 HER2-positive; 11,842 triple-negative) cancer, 5,822 with colorectal cancer, and 1,861 with pancreatic cancer were analyzed; the mean follow-up was 3.9 years. Patients with <i>ATM</i>, <i>CHEK2</i>, or <i>PALB2</i> PVs had no differences in breast, colorectal, or pancreatic cancer mortality. Patients with <i>ATM</i> PVs in triple-negative breast cancer appeared to have higher mortality in fixed effects models (hazard ratio [HR], 3.7 [95% CI, 1.8 to 7.8]), but not in random effects models (HR, 1.2 [95% CI, 0.8 to 1.6]) that reduce overfitting. Patients with <i>BRCA1</i>/<i>2</i> PVs had lower triple-negative breast cancer mortality in both models (fixed HR, 0.6 [95% CI, 0.5 to 0.9], random HR, 0.7 [95% CI, 0.6 to 0.8]). Patients with Lynch syndrome gene PVs had lower colorectal cancer mortality in both models (fixed HR, 0.5 [95% CI, 0.4 to 0.8], random HR, 0.7 [95% CI, 0.5 to 0.9]).</p><p><strong>Conclusion: </strong>Patients with <i>ATM</i>, <i>CHEK2</i>, or <i>PALB2</i> PVs had similar breast, colorectal, and pancreatic cancer mortality to the average genetically tested patient with their cancer type.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402442"},"PeriodicalIF":42.1,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143527809","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}