Journal of Clinical Oncology最新文献

{"title":"Reply to: Glofitamab for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma.","authors":"Tycel Jovelle Phillips","doi":"10.1200/JCO-25-00088","DOIUrl":"10.1200/JCO-25-00088","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1519-1520"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416805","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: 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-25-00466","DOIUrl":"10.1200/JCO-25-00466","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1521-1522"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656706","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":"Postoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer.","authors":"Mitchell Machtay, Pedro A Torres-Saavedra, Wade Thorstad, Phuc Felix Nguyen-Tân, Lillian L Siu, F Christopher Holsinger, Adel El-Naggar, Christine Chung, Anthony Cmelak, Barbara Burtness, Greg Bednarz, Harry Quon, Stephen L Breen, Clement K Gwede, Adam P Dicker, Min Yao, Richard C Jordan, Jennifer Dorth, Nancy Lee, Jason W Chan, Neal Dunlap, Voichita Bar-Ad, William A Stokes, Arnab Chakravarti, David Sher, Shyam Rao, Jonathan Harris, Sue S Yom, Quynh-Thu Le","doi":"10.1200/JCO-24-01829","DOIUrl":"10.1200/JCO-24-01829","url":null,"abstract":"<p><strong>Purpose: </strong>Radiotherapy (RT)/cetuximab (C) demonstrated superiority over RT alone for locally advanced squamous head and neck cancer. We tested this in completely resected, intermediate-risk cancer.</p><p><strong>Methods: </strong>Patients had squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, or larynx, with one or more risk factors warranting postoperative RT. Patients were randomly assigned 1:1 to intensity-modulated RT (60-66 Gy) with once-per-week C or RT alone. The primary hypothesis was that RT + C would improve overall survival (OS) in randomly assigned/eligible patients, with a prespecified secondary plan to test this in the human papillomavirus (HPV)-negative subpopulation. Disease-free survival (DFS) and toxicity were secondary end points. OS and DFS were tested via stratified log-rank test; toxicity was compared via Fisher's exact test.</p><p><strong>Results: </strong>We enrolled 702 patients from November 2009 to March 2018; 577 were randomly assigned/eligible. Most (63.6%) had oral cavity cancer and most (84.6%) had high epidermal growth factor receptor expression. There were fewer deaths (184) than expected. OS (median follow up, 7.2 years) was not significantly improved (hazard ratio [HR], 0.81; one-sided <i>P</i> = .0747; 5-year OS 76.5% <i>v</i> 68.7%), but DFS was (HR, 0.75; one-sided <i>P</i> = .0168; 5-year DFS 71.7% <i>v</i> 63.6%). Benefit of RT + C was only seen in the HPV-negative subpopulation (80.2% of patients in the trial). Grade 3-4 acute toxicity rates were 70.3% (RT + C) versus 39.7% (RT; two-sided <i>P</i> < .0001), mostly skin and/or mucosal effects. Late grade ≥3 toxicity rate was 33.2% (RT + C) versus 29.0% (RT; two-sided <i>P</i> = .3101). There were no grade 5 toxicities in either arm.</p><p><strong>Conclusion: </strong>RT + C significantly improved DFS, but not OS, with no increase in long-term toxicity, compared with RT alone for resected, intermediate-risk SCCHN. RT + C is an appropriate option for carefully selected patients with HPV-negative disease.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1474-1487"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12003072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023603","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":"Surrogate End Points for Overall Survival in Neoadjuvant Randomized Clinical Trials for Early Breast Cancer.","authors":"Fabio Conforti, Valentina Nekljudova, Isabella Sala, Roberto Ascari, Christine Solbach, Michael Untch, Carsten Denkert, Vincenzo Bagnardi, Laura Pala, Peter A Fasching, Andreas Schneeweiss, Hans-Joachim Lück, Eleonora Pagan, Tommaso De Pas, Marion van Mackelenbergh, Jens Huober, Volkmar Müller, Theresa Link, Thomas Karn, Mattea Reinisch, Frederik Marmé, Vesna Bjelic-Radisic, Christian Schem, Andreas Hartkopf, Elmar Stickeler, Claus Hanusch, Jens-Uwe Blohmer, Tanja Fehm, Kerstin Rhiem, Johannes Holtschmidt, Richard D Gelber, Sibylle Loibl","doi":"10.1200/JCO-24-01360","DOIUrl":"10.1200/JCO-24-01360","url":null,"abstract":"<p><strong>Purpose: </strong>To assess trial-level surrogacy value for overall survival (OS) of the pathologic complete response (pCR) and invasive disease-free survival (iDFS) in randomized clinical trials (RCTs) for early breast cancer (BC).</p><p><strong>Methods: </strong>Individual patient data of neoadjuvant RCTs with available data on pCR, iDFS, and OS were included in the analysis. We used the coefficient of determination <i>R</i>² from weighted linear regression models to quantify the association between treatment effects on OS and on the surrogate end points.</p><p><strong>Results: </strong>Eleven RCTs, for a total of 15 treatment comparisons and 12,247 patients, were included in the analysis. There was a weak association between hazard ratios (HRs) for OS and odds ratio of pCR overall (<i>R</i>², 0.07; 95% CI, 0.00 to 0.48), as well as in all the subgroups explored. Overall, the <i>R</i>² for the association between HR OS and HR iDFS was 0.46 (95% CI, 0.08 to 0.71), which is just below the cutoff of 0.5 for moderate surrogacy. In the majority of subgroups explored, the <i>R</i>² ranged from 0.5 to <0.7, while in hormone receptor-/human epidermal growth factor receptor 2- subtype, histologic grade 1-2 tumors, and lobular tumors, surrogacy was strong (ie, <i>R</i>² ≥0.7). The surrogacy value of iDFS for OS was affected by follow-up (FUP) length: <i>R</i>² substantially increased up to 36 months of FUP, with little further improvement after 48 months of FUP.</p><p><strong>Conclusion: </strong>iDFS with sufficient FUP is an acceptable surrogate end point to confidently anticipate final OS results of neoadjuvant RCTs for early BC. This recommendation holds true across many subgroups, with the notable exception of HR+ disease. There is definite need to reassess whether OS is the optimal end point for treatment efficacy measurement in HR+ early BC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1441-1452"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065793","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: Paclitaxel, Ifosfamide, and Cisplatin as Initial Salvage Chemotherapy for Germ Cell Tumors: Long-Term Follow-Up and Outcomes for Favorable- and Unfavorable-Risk Disease.","authors":"Jack P Gleeson, Andrea Knezevic, Maria Bromberg, Sujata Patil, Joel Sheinfeld, Brett S Carver, Manjit Bains, David R Jones, Dean F Bajorin, George J Bosl, Deaglan J McHugh, Samuel A Funt, Robert J Motzer, Darren R Feldman","doi":"10.1200/JCO-25-00475","DOIUrl":"10.1200/JCO-25-00475","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1521"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630560","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":"Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer.","authors":"Mark M Awad, Patrick M Forde, Nicolas Girard, Jonathan Spicer, Changli Wang, Shun Lu, Tetsuya Mitsudomi, Enriqueta Felip, Stephen R Broderick, Scott J Swanson, Julie Brahmer, Keith Kerr, Gene B Saylors, Ke-Neng Chen, Vishwanath Gharpure, Jaclyn Neely, David Balli, Nan Hu, Mariano Provencio Pulla","doi":"10.1200/JCO-24-02239","DOIUrl":"10.1200/JCO-24-02239","url":null,"abstract":"<p><strong>Purpose: </strong>Neoadjuvant immune checkpoint blockade with nivolumab plus ipilimumab improves overall survival (OS) in non-small cell lung cancer (NSCLC); however, randomized data for resectable lung cancer are limited. We report results from the exploratory concurrently randomized nivolumab plus ipilimumab and chemotherapy arms of the international phase III CheckMate 816 trial.</p><p><strong>Methods: </strong>Adults with stage IB-IIIA (American Joint Committee on Cancer seventh edition) resectable NSCLC received three cycles of nivolumab once every 2 weeks plus one cycle of ipilimumab or three cycles of chemotherapy (on day 1 or days 1 and 8 of each 3-week cycle) followed by surgery. Analyses included event-free survival (EFS), OS, pathologic response, surgical outcomes, biomarker analyses, and safety.</p><p><strong>Results: </strong>A total of 221 patients were concurrently randomly assigned to nivolumab plus ipilimumab (n = 113) or chemotherapy (n = 108). At a median follow-up of 49.2 months, the median EFS was 54.8 months (95% CI, 24.4 to not reached [NR]) with nivolumab plus ipilimumab versus 20.9 months (95% CI, 14.2 to NR) with chemotherapy (HR, 0.77 [95% CI, 0.51 to 1.15]); 3-year EFS rates were 56% versus 44%. Higher rates of EFS events were initially seen, with later benefit favoring nivolumab plus ipilimumab; 3-year OS rates were 73% versus 61% (HR, 0.73 [95% CI, 0.47 to 1.14]); pathologic complete response rates were 20.4% versus 4.6%, respectively. In the respective arms, 83 (74%) and 82 patients (76%) underwent definitive surgery. Grade 3-4 treatment-related adverse events occurred in 14% and 36% of patients, respectively.</p><p><strong>Conclusion: </strong>Neoadjuvant nivolumab plus ipilimumab showed potential long-term clinical benefit versus chemotherapy, despite early crossing of EFS curves in the preoperative phase and a lower rate of high-grade toxicity.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1453-1462"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12005868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949496","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 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma.","authors":"Yutaka Shimazu, Yayoi Shimazu","doi":"10.1200/JCO-24-02259","DOIUrl":"10.1200/JCO-24-02259","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1519"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416803","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":"Fertility Preservation in People With Cancer: ASCO Guideline Update.","authors":"H Irene Su, Christina Lacchetti, Joseph Letourneau, Ann H Partridge, Rubina Qamar, Gwendolyn P Quinn, Joyce Reinecke, James F Smith, Megan Tesch, W Hamish Wallace, Erica T Wang, Alison W Loren","doi":"10.1200/JCO-24-02782","DOIUrl":"10.1200/JCO-24-02782","url":null,"abstract":"<p><strong>Purpose: </strong>To provide updated fertility preservation (FP) recommendations for people with cancer.</p><p><strong>Methods: </strong>A multidisciplinary Expert Panel convened and updated the systematic review.</p><p><strong>Results: </strong>One hundred sixty-six studies comprise the evidence base.</p><p><strong>Recommendations: </strong>People with cancer should be evaluated for and counseled about reproductive risks at diagnosis and during survivorship. Patients interested in or uncertain about FP should be referred to reproductive specialists. FP approaches should be discussed before cancer-directed therapy. Sperm cryopreservation should be offered to males before cancer-directed treatment, with testicular sperm extraction if unable to provide semen samples. Testicular tissue cryopreservation in prepubertal males is experimental and should be offered only in a clinical trial. Males should be advised of potentially higher genetic damage risks in sperm collected soon after cancer-directed therapy initiation and completion. For females, established FP methods should be offered, including embryo, oocyte, and ovarian tissue cryopreservation (OTC), ovarian transposition, and conservative gynecologic surgery. In vitro maturation of oocytes may be offered as an emerging method. Post-treatment FP may be offered to people who did not undergo pretreatment FP or cryopreserve enough oocytes or embryos. Gonadotropin-releasing hormone agonist (GnRHa) should not be used in place of established FP methods but may be offered as an adjunct to females with breast cancer. For patients with oncologic emergencies requiring urgent oncologic therapy, GnRHa may be offered for menstrual suppression. Established FP methods in children who have begun puberty should be offered with patient assent and parent/guardian consent. The only established method for prepubertal females is OTC. Oncology teams should ensure prompt access to a multidisciplinary FP team. Clinicians should advocate for comprehensive FP services coverage and help patients access benefits.Additional information is available at www.asco.org/survivorship-guidelines.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1488-1515"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663608","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":"Machine Learning to Predict Mortality in Older Patients With Cancer: Development and External Validation of the Geriatric Cancer Scoring System Using Two Large French Cohorts.","authors":"Etienne Audureau, Pierre Soubeyran, Claudia Martinez-Tapia, Carine Bellera, Sylvie Bastuji-Garin, Pascaline Boudou-Rouquette, Anne Chahwakilian, Thomas Grellety, Olivier Hanon, Simone Mathoulin-Pélissier, Elena Paillaud, Florence Canouï-Poitrine","doi":"10.1200/JCO.24.00117","DOIUrl":"10.1200/JCO.24.00117","url":null,"abstract":"<p><strong>Purpose: </strong>Establishing an accurate prognosis remains challenging in older patients with cancer because of the population's heterogeneity and the current predictive models' reduced ability to capture the complex interactions between oncologic and geriatric predictors. We aim to develop and externally validate a new predictive score (the Geriatric Cancer Scoring System [GCSS]) to refine individualized prognosis for older patients with cancer during the first year after a geriatric assessment (GA).</p><p><strong>Materials and methods: </strong>Data were collected from two French prospective multicenter cohorts of patients with cancer 70 years and older, referred for GA: ELCAPA (training set January 2007-March 2016) and ONCODAGE (validation set August 2008-March 2010). Candidate predictors included baseline oncologic and geriatric factors and routine biomarkers. We built predictive models using Cox regression, single decision tree (DT), and random survival forest (RSF) methods, comparing their predictive performance for 3-, 6-, and 12-month mortalities by computing time-dependent area under the receiver operator curve (tAUC).</p><p><strong>Results: </strong>A total of 2,012 and 1,397 patients were included in the training and validation set, respectively (mean age: 81 ± 6 years/78 ± 5 years; women: 47%/70%; metastatic cancer: 50%/34%; 12-month mortality: 43%/16%). Tumor site/metastatic status, cancer treatment, weight loss, ≥five prescription drugs, impaired functional status and mobility, abnormal G-8 score, low creatinine clearance, and elevated C-reactive protein (CRP)/albumin were identified as relevant predictors in the Cox model. DT and RSF identified more complex combinations of features, with G-8 score, tumor site/metastatic status, and CRP/albumin ratio contributing most to the predictions. The RSF approach gave the highest tAUC (12 months: 0.87 [RSF], 0.82 [Cox], 0.82 [DT]) and was retained as the final model.</p><p><strong>Conclusion: </strong>The GCSS on the basis of a machine learning approach applied to two large French cohorts gave an accurate externally validated mortality prediction. The GCSS might improve decision making and counseling in older patients with cancer referred for pretherapeutic GA. GCSS's generalizability must now be confirmed in an international setting.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1429-1440"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143032365","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":"Missed Opportunity for Sotorasib Dose Optimization.","authors":"Garth W Strohbehn, Jill Feldman, Sanjay Popat, Mark J Ratain","doi":"10.1200/JCO-24-02468","DOIUrl":"10.1200/JCO-24-02468","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1518-1519"},"PeriodicalIF":42.1,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364928","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}