Journal of Clinical Oncology最新文献

{"title":"Comparative Analysis of Intracranial Response Assessment Criteria in Patients With Melanoma Brain Metastases Treated With Combination Nivolumab + Ipilimumab in CheckMate 204.","authors":"Raymond Y Huang, Gilbert Youssef, Thomas Nelson, Patrick Y Wen, Peter Forsyth, F Stephen Hodi, Kim Margolin, Alain P Algazi, Omid Hamid, Christopher D Lao, Marc S Ernstoff, Stergios J Moschos, Michael B Atkins, Michael A Postow, David A Reardon, Diederik J Grootendorst, David Leung, Margarita Askelson, Corey Ritchings, Hussein A Tawbi","doi":"10.1200/JCO.24.00953","DOIUrl":"https://doi.org/10.1200/JCO.24.00953","url":null,"abstract":"<p><strong>Purpose: </strong>In CheckMate 204, nivolumab + ipilimumab showed high intracranial (IC) objective response rates (icORRs) in patients with melanoma brain metastases (MBMs). Using icORR as a surrogate for overall survival (OS) has prompted use of alternate response criteria. To set the stage for harmonized MBM trials, the aim of this exploratory analysis was to determine icORR using several response criteria and examine correlations of response with survival.</p><p><strong>Methods: </strong>Patients (N = 119) with ≥one unirradiated MBMs received nivolumab + ipilimumab every 3 weeks (four doses), followed by nivolumab every 2 weeks for ≤24 months. Blinded review icORR was assessed with modified RECIST (mRECIST), Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM; 5 mm and 10 mm cutoffs), and volumetric criteria (5 mm and 10 mm). Using a 6-week response landmark, IC progression-free survival (icPFS) and OS were compared for responders versus nonresponders.</p><p><strong>Results: </strong>icORR was higher with mRECIST and volumetric criteria than with RANO-BM or RECIST. mRECIST and volumetric response also showed stronger correlations with icPFS and OS. mRECIST responders who were RANO-BM 5 mm nonresponders (n = 14) had similar OS to RANO-BM 5 mm responders (n = 41). Clinical deterioration affected RANO-BM icORR; however, when assessed only radiographically without deterioration, RANO-BM 5 mm performed similarly to mRECIST. Among 41 patients with target lesions all <10 mm, responder icPFS and OS were similar to those of responders in the total population, indicating that response could be accurately determined in these patients.</p><p><strong>Conclusion: </strong>This analysis supports mRECIST or radiographic-only RANO-BM 5 mm as reliable assessment scales in MBM trials. Volumetric response correlated with survival, supporting its application in future trials. Response could be accurately determined in patients with MBMs all <10 mm, supporting the inclusion of patients with MBMs ≥5 mm in future trials.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2400953"},"PeriodicalIF":42.1,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927129","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":"Improved Patient-Reported Outcomes With Post-Transplant Cyclophosphamide: A Quality-of-Life Evaluation and 2-Year Outcomes of BMT CTN 1703.","authors":"Shernan G Holtan, Javier Bolaños-Meade, Monzr M Al Malki, Juan Wu, Carrie L Kitko, Ran Reshef, Andrew R Rezvani, Brian C Shaffer, Melhem M Solh, Janny M Yao, Lyndsey Runaas, Hany Elmariah, Karilyn T Larkin, Najla El Jurdi, Mahasweta Gooptu, Alison W Loren, Aric C Hall, Amin M Alousi, Omer Jamy, William Clark, Leslie Kean, Ami S Bhatt, Miguel-Angel Perales, Kristy Applegate, Yvonne Adeduni Efebera, Eric Leifer, Richard J Jones, Mary M Horowitz, Deborah Mattila, Wael Saber, Mehdi Hamadani, Michael J Martens","doi":"10.1200/JCO.24.00921","DOIUrl":"https://doi.org/10.1200/JCO.24.00921","url":null,"abstract":"<p><p>The BMT CTN 1703 phase III trial confirmed that graft-versus-host disease (GVHD) prophylaxis with post-transplantation cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF) results in superior GVHD-free, relapse-free survival (GRFS) compared with Tac/methotrexate (MTX) prophylaxis. This companion study assesses the effect of these regimens on patient-reported outcomes (PROs). Using the Lee Chronic GVHD Symptom Score and PROMIS subscales (physical function, GI symptoms, social role satisfaction) as primary end points and hemorrhagic cystitis symptoms and Lee subscales as secondary end points, responses from English and Spanish speakers were analyzed at baseline and days 100, 180, and 365 after transplant. PRO scores were compared between the arms using inverse probability weighted-independent estimating equation models. The PTCy arm had significantly lower scores on the Lee Chronic GVHD Symptom Scale (<i>P</i> = .01), indicating lower GVHD symptom burden. Lee Scale nutrition and mouth subscores were also better in the PTCy arm compared with the Tac/MTX arm (<i>P</i> < .01 for both). Older participants (age >65 years) reported better Lee Scale psychological subscores than younger participants (<i>P</i> = .003). No significant differences were identified in hemorrhagic cystitis or in the PROMIS subscales between treatment arms. The updated clinical end points at 2 years for the parent trial confirmed that PTCy/Tac/MMF maintained a significant advantage over Tac/MTX in GRFS (42.4% <i>v</i> 28.8%, <i>P</i> = .001). In addition to improved GRFS, patients randomly assigned to the PTCy arm reported lower symptom burden during the first year after transplant.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2400921"},"PeriodicalIF":42.1,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927153","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":"Adjuvant Dose-Dense Chemotherapy in Hormone Receptor-Positive Breast Cancer.","authors":"Otto Metzger Filho, Karla Ballman, Jordan Campbell, Minetta Liu, Jennifer Ligibel, Mark Watson, Eveline Chen, Lili Du, Daniel Stover, Lisa Carey, Ann Partridge, Jeffrey Kirshner, Hyman Muss, Clifford Hudis, Eric P Winer, Larry Norton, W Fraser Symmans","doi":"10.1200/JCO-24-01875","DOIUrl":"10.1200/JCO-24-01875","url":null,"abstract":"<p><strong>Purpose: </strong>In light of evolving evidence that some patients with node-positive estrogen receptor-positive (ER+) disease may receive less benefit from chemotherapy, this study reports 12-year outcomes of the C9741 trial overall, and by the sensitivity to endocrine therapy (SET2,3) test index, a biomarker measuring endocrine transcriptional activity, to identify patients most likely to benefit from dose-dense chemotherapy.</p><p><strong>Methods: </strong>In all, 1,973 patients were randomly assigned to dose-dense versus conventional chemotherapy. Hazard ratios (HRs) for prognosis and for predictive interaction with chemotherapy schedule were estimated from Cox models of long-term disease-free survival (DFS) and overall survival (OS). SET2,3 was tested on the 682 banked RNA samples from ER+ cancers.</p><p><strong>Results: </strong>Dose-dense chemotherapy improved DFS in the overall study population by 23% (HR, 0.77 [95% CI, 0.66 to 0.90]) and OS by 20% (HR, 0.80 [95% CI, 0.67 to 0.95]); the benefits of dose-dense therapy were seen for ER+ and ER-negative subsets, without significant interaction between treatment arm and ER status. Low SET2,3 status was highly prognostic, but also predicted improved outcomes from dose-dense chemotherapy (interaction <i>P</i> = .0998 for DFS; 0.027 for OS), independent of menopausal status. Specifically, low endocrine transcriptional activity predicted benefit from dose-dense chemotherapy, whereas tumor burden and proliferation-driven signatures for molecular subtype classification did not.</p><p><strong>Conclusion: </strong>At 12-year follow-up, C9741 confirmed the sustained long-term benefit of adjuvant dose-dense chemotherapy for node-positive breast cancer. SET2,3 identified patients with ER+ breast cancer who benefited from dose-dense chemotherapy, and specifically, this benefit was predicted by low endocrine activity in the cancer, rather than tumor burden, molecular subtype, or menopausal status.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401875"},"PeriodicalIF":42.1,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921815","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":"https://doi.org/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":"JCO2400938"},"PeriodicalIF":42.1,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Single or Double Induction With 7 + 3 Containing Standard or High-Dose Daunorubicin for Newly Diagnosed AML: The Randomized DaunoDouble Trial by the Study Alliance Leukemia.","authors":"Christoph Röllig, Björn Steffen, Christoph Schliemann, Jan-Henrik Mikesch, Nael Alakel, Regina Herbst, Mathias Hänel, Richard Noppeney, Maher Hanoun, Martin Kaufmann, Barbora Weinbergerova, Kerstin Schäfer-Eckart, Tim Sauer, Andreas Neubauer, Andreas Burchert, Claudia D Baldus, Jolana Mertová, Edgar Jost, Dirk Niemann, Jan Novák, Stefan W Krause, Sebastian Scholl, Andreas Hochhaus, Gerhard Held, Tomas Szotkowski, Andreas Rank, Christoph Schmid, Lars Fransecky, Sabine Kayser, Markus Schaich, Michael Kramer, Frank Fiebig, Annett Haake, Johannes Schetelig, Jan Moritz Middeke, Friedrich Stölzel, Uwe Platzbecker, Christian Thiede, Carsten Müller-Tidow, Wolfgang E Berdel, Gerhard Ehninger, Jiri Mayer, Hubert Serve, Martin Bornhäuser","doi":"10.1200/JCO.24.00235","DOIUrl":"10.1200/JCO.24.00235","url":null,"abstract":"<p><strong>Purpose: </strong>To determine the optimal daunorubicin dose and number of 7 + 3 induction cycles in newly diagnosed AML, this randomized controlled trial compared a once daily dose of 60 mg/m² with 90 mg/m² daunorubicin in the first 7 + 3 induction and one versus two cycles of 7 + 3 induction.</p><p><strong>Patients and methods: </strong>Patients age 18-65 years with newly diagnosed AML were randomly assigned to 60 versus 90 mg/m² daunorubicin once daily plus cytarabine. Patients with marrow blasts below 5% on day 15 after first induction were randomly assigned to receive a second induction cycle or no second induction cycle.</p><p><strong>Results: </strong>Eight hundred and sixty-four patients with a median age of 52 years were randomly assigned. After a preplanned interim analysis showing no significant difference in response between 60 and 90 mg/m², all consecutive patients received 60 mg/m² daunorubicin once daily. The proportion of good early responders was 44% versus 48% (<i>P</i> = .983) with a composite complete remission (CRc) rate of 90% versus 89% after induction (<i>P</i> = .691); the 3-year relapse-free survival (RFS) after 60 versus 90 mg/m² once daily was 54% versus 50% (<i>P</i> = .561), and the 3-year overall survival (OS) was 65% versus 58% (<i>P</i> = .242). Among 389 good responders, CRc rates at the end of induction were 87% after single induction and 85% after double induction. The 3-year RFS was 51% versus 60% (hazard ratio [HR], 1.3; <i>P</i> = .091), and the 3-year OS was 76% versus 75% after single versus double induction (HR, 1.0; <i>P</i> = .937).</p><p><strong>Conclusion: </strong>The use of 90 mg/m² daunorubicin once daily in the context of classical 7 + 3 induction does not significantly improve early response and does not lead to higher remission rates or longer survival than 60 mg/m² once daily. In patients with a good early response after first induction, a second induction has only a limited impact on RFS and does not result in an OS benefit.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"65-74"},"PeriodicalIF":42.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142288234","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":"How Racialized Approaches to Opioid Use Disorder and Opioid Misuse Management Hamper Pharmacoequity for Cancer Pain.","authors":"Katie Fitzgerald Jones, Kevin T Liou, Rebecca L Ashare, Brooke Worster, Katherine A Yeager, Jessica Merlin, Salimah H Meghani","doi":"10.1200/JCO.24.00705","DOIUrl":"10.1200/JCO.24.00705","url":null,"abstract":"<p><p>@JCO_ASCO paper focuses on racialized approaches to OUD and opioid misuse as underappreciated drivers of disparities in cancer and recs a path forward.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"10-14"},"PeriodicalIF":42.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142288217","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":"Surveillance Systemic Imaging After Curative Intent for Breast Cancer: A Double Standard?","authors":"Humaid O Al-Shamsi, Nadia Abdelwahed, Kefah Mokbel","doi":"10.1200/JCO.24.01186","DOIUrl":"10.1200/JCO.24.01186","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"109-111"},"PeriodicalIF":42.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371964","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":"Effectiveness of a Cardiovascular Health Electronic Health Record Application for Cancer Survivors in Community Oncology Practice: Results From WF-1804CD.","authors":"Kathryn E Weaver, Emily V Dressler, Heidi D Klepin, Simon C Lee, Brian J Wells, Sydney Smith, W Gregory Hundley, Glenn J Lesser, Chandylen L Nightingale, Julie C Turner, Ian Lackey, Kevin Heard, Randi Foraker","doi":"10.1200/JCO.24.00342","DOIUrl":"10.1200/JCO.24.00342","url":null,"abstract":"<p><strong>Purpose: </strong>Guidelines recommend cardiovascular (CV) risk assessment and counseling for cancer survivors. This study evaluated the automated heart-health assessment (AH-HA) clinical decision support tool to promote provider-patient CV health (CVH) discussions in outpatient oncology.</p><p><strong>Methods: </strong>The AH-HA trial (WF-1804CD), coordinated by the Wake Forest National Cancer Institute Community Oncology Research Program Research Base, randomized practices to the AH-HA tool or usual care (UC) and enrolled survivors receiving routine care ≥6 months after curative cancer treatment. The tool displayed American Heart Association Life's Simple 7 CVH factors (BMI, physical activity, diet, smoking status, blood pressure, cholesterol, and glucose), populated from the electronic health record (EHR), alongside cancer treatments received with cardiotoxic potential. The primary end point was survivor-reported discussion of nonideal or missing CVH factors. A mixed-effects logistic regression model assessed the effect of AH-HA on CVH discussions, adjusting for practice.</p><p><strong>Results: </strong>Five UC and four AH-HA practices enrolled 645 survivors (82% breast, 8% endometrial, 5% colorectal, and 5% lymphoma, prostate, or multiple types) from October 1, 2020, to February 28, 2023. Most survivors were female (96%; 84% White/non-Hispanic, 8% Black; 3% Hispanic). Nearly all survivors (98%) in AH-HA practices reported a discussion for ≥1 nonideal or missing CVH factor compared with 55% in UC (<i>P</i> < .001). The average number of survivor-reported factors discussed was higher in AH-HA compared with UC (mean, 4.06 <i>v</i> 1.27; <i>P</i> < .001), as were EHR-documented discussions (3.83 <i>v</i> 0.77; <i>P</i> = .03). Survivors in AH-HA practices were also significantly more likely to report a recommendation to see a primary care provider (39%) compared with UC practices (25%, <i>P</i> = .02). Reported recommendations to see a cardiologist were low (approximately 6%) and did not differ between groups.</p><p><strong>Conclusion: </strong>The AH-HA tool was effective at promoting CVH discussions during routine follow-up care for survivors and recommendations to consult primary care.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"46-56"},"PeriodicalIF":42.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687049","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":"Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274.","authors":"Matthew D Galsky, Johannes Alfred Witjes, Jürgen E Gschwend, Matthew I Milowsky, Michael Schenker, Begoña P Valderrama, Yoshihiko Tomita, Aristotelis Bamias, Thierry Lebret, Shahrokh F Shariat, Se Hoon Park, Mads Agerbaek, Gautam Jha, Frank Stenner, Dingwei Ye, Fabio Giudici, Santanu Dutta, Margarita Askelson, Federico Nasroulah, Joshua Zhang, Lynne Brophy, Dean F Bajorin","doi":"10.1200/JCO.24.00340","DOIUrl":"10.1200/JCO.24.00340","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>.CheckMate 274 is a phase III, randomized, double-blind trial of adjuvant nivolumab versus placebo for muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after radical resection. The primary end points of disease-free survival (DFS) in intent-to-treat (ITT) and tumor PD-L1 expression ≥1% populations were met. We report results at an extended median follow-up of 36.1 months in the ITT population. In addition, we report interim overall survival (OS) data for the first time and an exploratory analysis among patients with bladder primary tumors (muscle-invasive bladder cancer [MIBC]). Consistent DFS benefit with nivolumab versus placebo was observed in both the ITT (hazard ratio [HR], 0.71 [95% CI, 0.58 to 0.86]) and PD-L1 ≥1% (HR, 0.52 [95% CI, 0.37 to 0.72]) patients. The HR for OS with nivolumab versus placebo was 0.76 (95% CI, 0.61 to 0.96) in the ITT population and 0.56 (95% CI, 0.36 to 0.86) in the PD-L1 ≥1 population. Continuous benefit in nonurothelial tract recurrence-free survival and distant metastasis-free survival was also observed in both patient populations. The exploratory analysis of patients with MIBC also showed continued efficacy benefits, irrespective of PD-L1 status. No new safety signals were reported. Overall, these results further support adjuvant nivolumab as a standard of care for high-risk MIUC after radical resection.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"15-21"},"PeriodicalIF":42.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11687940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142406447","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":"Erratum: Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes.","authors":"","doi":"10.1200/JCO-24-02469","DOIUrl":"10.1200/JCO-24-02469","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"113"},"PeriodicalIF":42.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675948","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}