Jama Oncology最新文献

{"title":"Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Nonrandomized Clinical Trial.","authors":"Ari J Rosenberg, Aditya Juloori, Michael J Jelinek, Nishant Agrawal, John F Cursio, Nicole Cipriani, Mark W Lingen, Evgeny Izumchenko, Rohan Katipally, Jeffrey Chin, Daniel Ginat, Olga Pasternak-Wise, Zhen Gooi, Elizabeth Blair, Alexander T Pearson, Daniel J Haraf, Everett E Vokes","doi":"10.1001/jamaoncol.2025.0081","DOIUrl":"10.1001/jamaoncol.2025.0081","url":null,"abstract":"<p><strong>Importance: </strong>Neoadjuvant immunotherapy in human papillomavirus (HPV)-negative locoregionally advanced (LA) head and neck squamous cell carcinoma (HNSCC) appears promising, yet its role in nonsurgical treatment for head and neck cancer remains undefined. Neoadjuvant nivolumab plus chemotherapy followed by response-stratified de-escalated chemoradiation therapy (CRT) in HPV-negative LA stage IVa/b HNSCC may improve treatment efficacy while reducing treatment-related toxic effects.</p><p><strong>Objective: </strong>To determine the deep response rate and tolerability of neoadjuvant nivolumab plus chemotherapy followed by response-stratified CRT in nonvirally mediated stage IVa/b HNSCC.</p><p><strong>Design, setting, and participants: </strong>In this investigator-initiated phase 2 nonrandomized clinical trial conducted at a single academic center, patients with stage IVa/b (American Joint Committee on Cancer Tumor Classification, 8th edition) HPV-negative LA HNSCC were enrolled between 2019 and 2022. Data were analyzed from February 2023 to January 2024.</p><p><strong>Interventions: </strong>The DEPEND trial evaluated neoadjuvant nivolumab plus carboplatin and paclitaxel, followed by response-stratified CRT. Patients with 50% or greater reduction per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 received de-escalated CRT to 66 Gy with elimination of elective nodal volumes; patients with less than 50% reduction received standard CRT to 70 to 75 Gy. Adjuvant nivolumab was administered for 9 cycles.</p><p><strong>Main outcomes and measures: </strong>The primary end point was deep response rate (DRR; 50% or greater shrinkage per RECIST version 1.1) following neoadjuvant nivolumab plus chemotherapy. Secondary end points included progression-free survival (PFS), overall survival (OS), locoregional control, and distant control. Exploratory end points included acute toxic effects in patients who received response-adapted de-escalated CRT.</p><p><strong>Results: </strong>Of 36 included patients, 28 (78%) were male, and the median (range) age was 58.9 (27-77) years. All patients started treatment and were available for analysis. The median (range) follow-up was 20 (13-40) months. The primary end point was met, with a DRR following neoadjuvant nivolumab/chemotherapy of 53% (95% CI, 35-70). The objective response rate was 86% (95% CI, 71-95). A total of 19 received de-escalated CRT and 16 received standard CRT. PFS and OS at 2 years were 66% (95% CI, 34-76) and 73% (95% CI, 52-86), respectively. The most common treatment-emergent adverse events for de-escalated and standard CRT were mucositis (14 of 19 [74%] and 15 of 16 [94%], respectively), radiation dermatitis (13 of 19 [68%] and 14 of 16 [88%], respectively), and dry mouth (7 of 19 [37%] and 10 of 16 [63%], respectively).</p><p><strong>Conclusions and relevance: </strong>In this phase 2 nonrandomized clinical trial, neoadjuvant nivolumab/chemotherapy led to deep respon","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568529","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":"Methodology Concerns Regarding Claims Data Studies in Transgender Health-Reply.","authors":"Celeste Manfredi, Marco De Sio, Riccardo Autorino","doi":"10.1001/jamaoncol.2025.0026","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.0026","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568527","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":"Efficacy of Hand Cooling and Compression in Preventing Taxane-Induced Neuropathy: The POLAR Randomized Clinical Trial.","authors":"Laura L Michel, Daniel Schwarz, Philipp Romar, Manuel Feisst, Daniel Hamberger, Anastasia Priester, Eileen Kurre, Eva Klein, Jana Müller, Timo Schinköthe, Markus Weiler, Katharina Smetanay, Carlo Fremd, Sabine Heublein, Verena Thewes, Michael O Breckwoldt, Dirk Jäger, Martin Bendszus, Frederik Marmé, Andreas Schneeweiss","doi":"10.1001/jamaoncol.2025.0001","DOIUrl":"10.1001/jamaoncol.2025.0001","url":null,"abstract":"<p><strong>Importance: </strong>Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting adverse effect of taxane-based chemotherapies. Currently, there is no established strategy for prevention or treatment.</p><p><strong>Objective: </strong>To compare the effectiveness of 1-sided hand cooling and compression for preventing CIPN in patients with primary breast cancer receiving taxane-based chemotherapy.</p><p><strong>Design, setting, and participants: </strong>The POLAR randomized clinical trial was conducted at the National Center for Tumor Diseases Heidelberg between November 2019 and January 2022. Female patients with breast cancer who received weekly nab-paclitaxel-based or paclitaxel-based neoadjuvant or adjuvant chemotherapy were enrolled. Patients with prior chemotherapy, preexisting neuropathy, or neuropathy-related comorbidities were excluded.</p><p><strong>Interventions: </strong>Patients were randomized 1:1 to cooling or compression of the dominant hand. No intervention was performed on the other hand. Cooling was performed with a frozen glove and compression was applied by 2 surgical gloves (1 size smaller than the tight-fitting size) 30 minutes before, after, and during taxane administration.</p><p><strong>Main outcomes and measures: </strong>The primary end point was the efficacy to prevent grade 2 or higher sensory CIPN evaluated by Common Terminology Criteria for Adverse Events, version 5.0. Further CIPN assessment included the clinical version of the Total Neuropathy Score and QLQ CIPN20. CIPN rates were compared between intervention groups. Nail toxic effects, quality of life, CIPN-associated dose reductions, treatment discontinuations, and risk factors were evaluated. Follow-up examinations were performed 1 week, 1 month, and 6 to 8 months after the last taxane dose.</p><p><strong>Results: </strong>A total of 122 female patients with primary breast cancer (mean [SD] age, 50 [12] years) were randomized to either cooling or compression of the dominant hand. Twenty-one individuals withdrew from the study, so 101 patients were included in the final analysis (n = 52 and n = 49 for cooling and compression, respectively). Both interventions significantly reduced the incidence of grade 2 or higher CIPN (cooling: 15 participants experiencing high-grade CIPN in the cooling arm [29%] vs 26 in the control arm [50%]; P = .002; effect size, 21.15% [95% CI, 5.98%-35.55%]; compression: 12 participants experiencing CIPN in the intervention arm [24%] vs 19 in the control arm [38%]; P = .008; effect size, 14.29% [95% CI, 2.02%-27.24%]). CIPN was the main reason for treatment discontinuations in 16 of 24 participants (67%). The predominant risk factors were the cumulative taxane dosage and the neurotoxic agent. Participants experiencing grade 2 or higher CIPN showed a reduced global health status during and 6 to 8 months after taxane therapy.</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial, ","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568522","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":"Critical Review on Breast Cancer Research-Reply.","authors":"Julia S Wong, Hajime Uno, Rinaa S Punglia","doi":"10.1001/jamaoncol.2024.6322","DOIUrl":"10.1001/jamaoncol.2024.6322","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"353"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025392","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":"Critical Review on Breast Cancer Research.","authors":"Kwok Ying Chan, Chi Yan Wong","doi":"10.1001/jamaoncol.2024.6319","DOIUrl":"10.1001/jamaoncol.2024.6319","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"352"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025391","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":"New CMS Illness Navigation Codes: LinchPIN to Ensuring Better Access to Care?","authors":"John E Dobbs, Samyukta Mullangi, S M Qasim Hussaini","doi":"10.1001/jamaoncol.2024.6270","DOIUrl":"10.1001/jamaoncol.2024.6270","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"235-236"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025394","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":"Correction to Open Access.","authors":"","doi":"10.1001/jamaoncol.2024.6781","DOIUrl":"10.1001/jamaoncol.2024.6781","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"354"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11926621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025390","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":"Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial.","authors":"Stephen Daw, Peter D Cole, Bradford S Hoppe, David Hodgson, Auke Beishuizen, Nathalie Garnier, Salvatore Buffardi, Maurizio Mascarin, Andrej Lissat, Christine Mauz-Körholz, Jennifer Krajewski, Alev Akyol, Russell Crowe, Bailey Anderson, Yan Xu, Richard A Drachtman, Kara M Kelly, Thierry Leblanc, Paul Harker-Murray","doi":"10.1001/jamaoncol.2024.5627","DOIUrl":"10.1001/jamaoncol.2024.5627","url":null,"abstract":"<p><strong>Importance: </strong>Retrieval strategies for children, adolescents, and young adults with relapsed classic Hodgkin lymphoma (cHL) aim to maintain efficacy while minimizing long-term toxic effects. Children, adolescents, and young adults with low-risk, relapsed cHL may benefit from replacing high-dose chemotherapy and autologous stem cell transplant with less intensive involved-site radiotherapy (ISRT).</p><p><strong>Objective: </strong>To evaluate a risk-stratified, response-adapted, transplant-free approach for treatment of children, adolescents, and young adults with low-risk relapsed cHL with nivolumab plus brentuximab vedotin (BV) followed by BV plus bendamustine for patients with suboptimal response and ISRT (30.0 to 30.6 Gy).</p><p><strong>Design, setting, and participants: </strong>CheckMate 744 (R1 cohort) was a phase 2, nonrandomized, single-arm study enrolling children, adolescents, and young adults aged 5 to 30 years with low-risk cHL between September 25, 2017, and December 16, 2020, across the US, Canada, and Europe. Data were analyzed from September 2017 to November 2022.</p><p><strong>Exposures: </strong>Patients received 4 cycles of nivolumab plus BV induction; patients with complete metabolic response (CMR) received an additional 2 cycles of nivolumab plus BV while patients with suboptimal response received 2 cycles of BV plus bendamustine intensification. Patients with CMR after induction or intensification received ISRT consolidation.</p><p><strong>Main outcomes and measures: </strong>Prespecified coprimary end points were CMR rate (Lugano 2014 classification) any time before ISRT and 3-year event-free survival (EFS) rate, per blinded independent central review (BICR).</p><p><strong>Results: </strong>Of 28 included patients treated in the low-risk cohort, 18 (64%) were female, and the median (range) age was 17 (6-27) years. At a median (range) follow-up of 31.9 (2.2-55.3) months, CMR per BICR any time before ISRT was 93% (26 of 28; 90% CI, 79.2-98.7; objective response rate [ORR], 100%), and 23 of 28 (82%) achieved CMR per BICR after 4 cycles of nivolumab plus BV (ORR, 96.4%). Kaplan-Meier estimates of EFS and progression-free survival rates at 3 years were 87% (3 of 18; 90% CI, 69.5-94.7) and 95% (1 of 18; 90% CI, 76.7-99.0), respectively. During induction, 22 patients (79%) had treatment-related adverse events, including 7 with grade 3 or 4 adverse events, 2 with anemia, 1 with neutropenia, and 6 with immune-mediated adverse events. Serious adverse events leading to discontinuation occurred in 2 patients.</p><p><strong>Conclusions and relevance: </strong>This nonrandomized clinical trial found that for children, adolescents, and young adults with low-risk, relapsed cHL, a transplant-free, risk-adapted, response-based approach with nivolumab plus BV and ISRT offered high CMR rates and high 3-year EFS rate, with a safety profile consistent with that of each agent used.</p><p><strong>Trial registration: </strong>Clin","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"249-257"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11926625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916075","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":"Weight Changes and Heart Failure Risk After Breast Cancer Development.","authors":"Wonyoung Jung, Yong-Moon Mark Park, Jonghan Yu, Jung Eun Yoo, In Young Cho, Kyungdo Han, Dong Wook Shin","doi":"10.1001/jamaoncol.2024.5803","DOIUrl":"10.1001/jamaoncol.2024.5803","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"342-345"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11926620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957187","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":"Ten Years After Diagnosis.","authors":"Judith Redwing Keyssar","doi":"10.1001/jamaoncol.2024.6730","DOIUrl":"10.1001/jamaoncol.2024.6730","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"356"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068957","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}