Jama Oncology最新文献

{"title":"Methodology Concerns Regarding Claims Data Studies in Transgender Health.","authors":"Ole-Petter R Hamnvik, Don S Dizon, Alberto Giovanni Leone","doi":"10.1001/jamaoncol.2025.0020","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.0020","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":"143568524","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":"Methodology Concerns Regarding Claims Data Studies in Transgender Health.","authors":"Alison M Berner, Stewart O'Callaghan, Sarah S Jackson","doi":"10.1001/jamaoncol.2025.0023","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.0023","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":"143568525","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":"Key Challenges in CAR T-Cell Therapy Access in Community Oncology.","authors":"Michael T Byrne, Aaron J Lyss, Samyukta Mullangi","doi":"10.1001/jamaoncol.2025.0042","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.0042","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":"143568523","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 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":"https://doi.org/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":"","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":"","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":"https://doi.org/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":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Partnership to Advance Care of Patients With Acute Promyelocytic Leukemia.","authors":"Ross McCauley, Eunice S Wang","doi":"10.1001/jamaoncol.2024.6649","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.6649","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516981","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":"Long-Term Toxicity of Immune Checkpoint Inhibitors-Time to Widen the Lens.","authors":"Christopher Cronin, Aoife O'Sullivan, Jarushka Naidoo","doi":"10.1001/jamaoncol.2024.6809","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.6809","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516992","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":"Academic Community Partnership in Acute Promyelocytic Leukemia and Early Mortality: The ECOG-ACRIN EA9131 Trial.","authors":"Anand P Jillella, Sandra J Lee, Jessica K Altman, Selina M Luger, Martin S Tallman, James M Foran, Danielle Bradshaw, Lisa Y Law, Locke J Bryan, Abdallah Abou Zahr, Kebede H Begna, Alexander E Perl, Joseph J L Vadakara, Rubina Qamar, Raymond C Bergan, Michael J Fisch, Ruth C Carlos, Lynne I Wagner, Vamsi K Kota, Mark R Litzow","doi":"10.1001/jamaoncol.2024.7033","DOIUrl":"10.1001/jamaoncol.2024.7033","url":null,"abstract":"<p><strong>Importance: </strong>Acute promyelocytic leukemia (APL) is an acute illness that presents with cytopenia, infections, and disseminated intravascular coagulation. Achieving remission has been shown to make a major difference in patient outcomes; however, early death rates in the first month have been as high as 30% due to acute presentation, comorbidities, the rarity of APL, and clinician inexperience.</p><p><strong>Objective: </strong>To develop treatment strategies that would decrease estimated 1-month mortality from 30% to below 15%.</p><p><strong>Design, setting, and participants: </strong>In this nonrandomized clinical trial, a treatment algorithm that focused on supportive care was used to prevent early death in patients with APL treated at academic and community health centers between August 2017 and July 2021. Because of the rarity of the disease, expert support was available 24/7 from 7 designated APL experts at 6 participating academic lead centers, and included an additional 293 community centers. When a patient presented with APL, an expert was contacted and a consensus treatment plan was developed using the algorithm and expert suggestions. There were no exclusion criteria and all patients with a confirmed diagnosis of APL regardless of age or comorbid conditions were enrolled. Expert support was provided throughout induction. Initial data analysis was conducted May 2023.</p><p><strong>Main outcomes and measures: </strong>One-month mortality; additional objectives were to compare outcomes in academic and community centers and assess 1-year and overall survival.</p><p><strong>Results: </strong>A total of 201 patients were enrolled from 43 centers; 62 at lead centers and 139 from 37 community centers. The median age was 53 years (range, 18-91 years), with 72 patients (35.8%) who were aged 60 years or older; 105 patients (52.2%) were male. Fifty-two patients (26.4%) were diagnosed with high-risk APL. The 1-month mortality rate was 6 deaths of 201 patients (3.0%; 95% CI, 1.1%-6.4%) after adjusting for 1 interim analysis. In a secondary analysis using the Kaplan-Meier method, the 1-month overall survival (OS) rate was 97.0% (95% CI, 93.5%-98.6%) and the 1-year OS rate was 94.5% (95% CI, 90.3%-96.9%).</p><p><strong>Conclusions and relevance: </strong>In this nonrandomized clinical trial, use of an algorithm combined with expert support resulted in a dramatic decrease in early death in academic and community centers. Population-wide survival improved in this highly curable disease, which suggests that implementing an accessible support system with APL experts for comanagement is the most logical next step.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03253848.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516988","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":"The Oncology Industrial Complex-Community Oncology Must Be Given a Seat at the Table-Reply.","authors":"S Gail Eckhardt, Leonidas C Platanias","doi":"10.1001/jamaoncol.2024.7018","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.7018","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517047","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}