JAMA Oncology最新文献

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Access to Dental Care for Patients With Cancer-Time for Broader Policy? 癌症患者获得牙科护理的机会——是否需要更广泛的政策?
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-10 DOI: 10.1001/jamaoncol.2025.1988
Nosayaba Osazuwa-Peters,Jad F Zeitouni,Lisa E Simon,Mark A Varvares
{"title":"Access to Dental Care for Patients With Cancer-Time for Broader Policy?","authors":"Nosayaba Osazuwa-Peters,Jad F Zeitouni,Lisa E Simon,Mark A Varvares","doi":"10.1001/jamaoncol.2025.1988","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1988","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"22 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593878","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}
引用次数: 0
A Novel Adjuvant Chemoradiotherapy/Immunotherapy for Resected Biliary Cancer. 一种新的辅助放化疗/免疫治疗胆道癌切除术。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-10 DOI: 10.1001/jamaoncol.2025.1912
Edgar Ben-Josef,Andrew M Lowy
{"title":"A Novel Adjuvant Chemoradiotherapy/Immunotherapy for Resected Biliary Cancer.","authors":"Edgar Ben-Josef,Andrew M Lowy","doi":"10.1001/jamaoncol.2025.1912","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1912","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"16 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593877","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}
引用次数: 0
Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer. 局部晚期直肠癌的全新辅助治疗。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-10 DOI: 10.1001/jamaoncol.2025.2026
Alessandro Audisio,Chiara Gallio,Vaneja Velenik,Hélène Meillat,Erika Ruiz-Garcia,Maria Carmen Riesco,Javier Suárez Alecha,Gertjan Rasschaert,Carlos Carvalho,Violaine Randrian,Iva Kirac,Jorge Hernando,Mehmet Artaç,Juan Manuel O'Connor,Ithai Waldhorn,Pètra M Braam,Ali Shamseddine,Roberto Moretto,Carolina De la Pinta,Francesca De Felice,Audrius Dulskas,David Páez López-Bravo,Alexander Vanden Bulcke,Felix Bock,Amélie Deleporte,Marc Van Den Eynde,Karen P Geboes,Mauro Loi,Marco Messina,Constance Houlzé-Laroye,Alberto Puccini,Alessandro Pastorino,Demetris Papamichael,Michele Fiore,Daniel Sur,Michal Eid,Claire Antoun,Massimiliano Salati,Ingrid Garajovà,Matas Jakubauskas,Jirí Tomášek,Cidália Maria Sousa Pinto,Jerome Schwingel,Federica Morano,Richard A Adams,Alexandre Dermine,Amélie Chau,Muhammad Ahsan Javed,Michele Ghidini,Francesco Fiorica,Paola Montenegro,Angelica Petrillo,Gaya Spolverato,Núria Mulet Margalef,Marie Diaz,Chiara Baratelli,Francesco Puleo,Athanasios Karampeazis,Fatma Sert,Quentin Gilliaux,Alfonso De Stefano,Gabriel Liberale,Luigi Moretti,Philippe Martinive,Vaiva Deltuvaite Thomas,Vincent Staggs,Everardo D Saad,Jean-Luc Van Laethem,Francesco Sclafani,
{"title":"Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer.","authors":"Alessandro Audisio,Chiara Gallio,Vaneja Velenik,Hélène Meillat,Erika Ruiz-Garcia,Maria Carmen Riesco,Javier Suárez Alecha,Gertjan Rasschaert,Carlos Carvalho,Violaine Randrian,Iva Kirac,Jorge Hernando,Mehmet Artaç,Juan Manuel O'Connor,Ithai Waldhorn,Pètra M Braam,Ali Shamseddine,Roberto Moretto,Carolina De la Pinta,Francesca De Felice,Audrius Dulskas,David Páez López-Bravo,Alexander Vanden Bulcke,Felix Bock,Amélie Deleporte,Marc Van Den Eynde,Karen P Geboes,Mauro Loi,Marco Messina,Constance Houlzé-Laroye,Alberto Puccini,Alessandro Pastorino,Demetris Papamichael,Michele Fiore,Daniel Sur,Michal Eid,Claire Antoun,Massimiliano Salati,Ingrid Garajovà,Matas Jakubauskas,Jirí Tomášek,Cidália Maria Sousa Pinto,Jerome Schwingel,Federica Morano,Richard A Adams,Alexandre Dermine,Amélie Chau,Muhammad Ahsan Javed,Michele Ghidini,Francesco Fiorica,Paola Montenegro,Angelica Petrillo,Gaya Spolverato,Núria Mulet Margalef,Marie Diaz,Chiara Baratelli,Francesco Puleo,Athanasios Karampeazis,Fatma Sert,Quentin Gilliaux,Alfonso De Stefano,Gabriel Liberale,Luigi Moretti,Philippe Martinive,Vaiva Deltuvaite Thomas,Vincent Staggs,Everardo D Saad,Jean-Luc Van Laethem,Francesco Sclafani, ","doi":"10.1001/jamaoncol.2025.2026","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2026","url":null,"abstract":"ImportanceThis was a clinical study of total neoadjuvant therapy (TNT) for rectal cancer.ObjectiveTo assess the use and outcomes of TNT in routine practice.Design, Setting, and ParticipantsThis international, multicenter study was conducted at 61 centers across 21 countries and included consecutive patients treated off trial with TNT for stage II/III rectal adenocarcinoma from September 2012 to December 2023. Data were analyzed between August and October 2024.ExposureTNT, defined as the delivery of radiotherapy and nonradiosensitizing chemotherapy before surgery or watch and wait.Main Outcomes and MeasuresThe primary outcome was type of TNT administered. Secondary outcomes were patient characteristics, treatment adherence, safety, and efficacy overall and by type of TNT in the entire population and after propensity vector matching.ResultsA total of 1585 patients (588 female [37.1%]; median [IQR] age, 61 [53-68] years) were included, 1260 (79.5%) of whom had 1 or more high-risk features (eg, cT4, cN2, extramural venous invasion, threatened/involved mesorectal fascia, and lateropelvic lymphadenopathy). Patients were treated with the PRODIGE 23-like regimen (FOLFIRINOX/FOLFOXIRI followed by long-course chemoradiotherapy) (271 [17.7%]), RAPIDO-like regimen (short-course radiotherapy followed by consolidation FOLFOX/CAPOX) (529 [33.4%]), OPRA induction-like (induction FOLFOX/CAPOX followed by long-course chemoradiotherapy) (190 [12.0%]), OPRA consolidation-like (long-course chemoradiotherapy followed by consolidation FOLFOX/CAPOX) (257 [16.2%]), and other regimens (360 [22.7%]). After TNT, 192 (12.1%) underwent watch and wait, and 30 (1.9%) underwent local excision. Pathological or clinical complete response was reported in 23.2% of cases. At treatment failure, 8.5% was local and 16.4% was distant progression. Three-year event-free survival (EFS) was 68% (95% CI, 64%-71%), and 5-year overall survival (OS) was 79% (95% CI, 75%-83%). In the overall population, patients treated with the PRODIGE 23-like regimen were most likely to have serious adverse events (61 [23.5%]) but had better local control and survival outcomes than those treated with the RAPIDO-like (EFS: hazard ratio [HR], 0.68; 95% CI, 0.49-0.95; P = .03; OS: HR, 0.51; 95% CI, 0.27-0.97; P = .04), OPRA induction-like (EFS: HR, 0.66; 95% CI, 0.44-0.98; P = .04; OS: HR, 0.35; 95% CI, 0.18-0.70; P = .003), and OPRA consolidation-like (EFS: HR, 0.64; 95% CI, 0.44-0.93; P = .02; OS: HR, 0.50; 95% CI, 0.25-1.00; P = .05) regimens. In the matched population (928 patients [58.5%]), no differences in survival outcomes were observed between the TNT regimens.Conclusions and RelevanceThe findings of this case series study show substantial variation in the choice of the TNT regimen and were overall aligned with those reported in clinical trials, suggesting the efficacy of TNT in a clinical setting regardless of the specific regimen.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"21 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593976","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}
引用次数: 0
First-Line Therapy For Advanced Non-Clear Cell Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. 晚期非透明细胞肾细胞癌的一线治疗:系统回顾和荟萃分析。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-03 DOI: 10.1001/jamaoncol.2025.1891
Fausto Petrelli,Elena Verri,Antonio Ghidini,Ivano Vavassori,Veronica Lonati,Franco Nolè,Lorenzo Dottorini
{"title":"First-Line Therapy For Advanced Non-Clear Cell Renal Cell Carcinoma: A Systematic Review and Meta-Analysis.","authors":"Fausto Petrelli,Elena Verri,Antonio Ghidini,Ivano Vavassori,Veronica Lonati,Franco Nolè,Lorenzo Dottorini","doi":"10.1001/jamaoncol.2025.1891","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1891","url":null,"abstract":"ImportanceNon-clear cell renal cell carcinomas (nccRCCs) present considerable challenges owing to their heterogeneity and limited clinical trial representation. Understanding the benefits of combining immunotherapy and targeted therapy for these subtypes is crucial for improving patient outcomes.ObjectiveTo evaluate the efficacy of various first-line immunotherapy combinations and targeted therapy in treating metastatic nccRCC.Data SourcesA systematic literature search was conducted across PubMed, Embase, and Cochrane Library databases from inception until December 31, 2024, using relevant keywords and medical subject headings terms.Study SelectionStudies were included if they involved patients with nccRCC, reported on immune checkpoint inhibitor (ICI)-based therapies, and provided data on objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR).Data extraction and SynthesisTwo independent reviewers extracted data, with discrepancies resolved by a third expert. Observational study quality was assessed using the Newcastle-Ottawa Scale. A random-effects meta-analysis was performed, and heterogeneity was evaluated using the I2 statistic.Main Outcome and MeasuresThe primary outcomes of interest were ORR, PFS, OS, and DCR.ResultsThe analysis included 23 studies encompassing various subtypes of nccRCC. Pooled results indicated an ORR of 26.6% and a DCR of 57.8% for nccRCC treatments. Median PFS was 6.59 months, and the median OS was 21.11 months. ICIs demonstrated significant efficacy in nccRCC, exhibiting marked clinical activity across different subtypes. Although monotherapy with ICIs showed effectiveness, combination therapies yielded superior clinical outcomes.Conclusions and RelevanceThis systematic review and meta-analysis found that ICIs, particularly when combined with targeted therapies, showed promising efficacy in treating metastatic nccRCC. These findings support their integration into treatment guidelines and emphasize the importance of personalized treatment strategies. Future research should focus on long-term outcomes, safety profiles, and the identification of biomarkers to optimize patient selection and improve outcomes.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"46 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144547723","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}
引用次数: 0
Nivolumab and Ipilimumab Combination Treatment in Advanced Ovarian and Endometrial Clear Cell Cancers: A Nonrandomized Clinical Trial. Nivolumab和Ipilimumab联合治疗晚期卵巢和子宫内膜透明细胞癌:一项非随机临床试验。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-03 DOI: 10.1001/jamaoncol.2025.1916
Bo Gao,Matteo S Carlino,Michael Michael,Craig Underhill,Henry Marshall,Ashray Gunjur,Jane So,Damien Kee,Yoland Antill,Wei-Sen Lam,Howard Chan,Rosemary Harrup,Anne Hamilton,John Grady,Mandy Ballinger,Elnaz Tavancheh,Won-Hee Yoon,Jodie Palmer,David Thomas,Kylie Wilkie,Jonathan Cebon,Oliver Klein
{"title":"Nivolumab and Ipilimumab Combination Treatment in Advanced Ovarian and Endometrial Clear Cell Cancers: A Nonrandomized Clinical Trial.","authors":"Bo Gao,Matteo S Carlino,Michael Michael,Craig Underhill,Henry Marshall,Ashray Gunjur,Jane So,Damien Kee,Yoland Antill,Wei-Sen Lam,Howard Chan,Rosemary Harrup,Anne Hamilton,John Grady,Mandy Ballinger,Elnaz Tavancheh,Won-Hee Yoon,Jodie Palmer,David Thomas,Kylie Wilkie,Jonathan Cebon,Oliver Klein","doi":"10.1001/jamaoncol.2025.1916","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1916","url":null,"abstract":"ImportanceGynecological clear cell cancers (CCCs) are aggressive malignant neoplasms with low response rate to chemotherapy. The treatment of patients with metastatic disease remains an area of significant unmet need.ObjectiveTo evaluate the efficacy of combined anti-programmed cell death 1 protein (PD-1)/cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blockade using nivolumab and ipilimumab in advanced gynecological CCCs.Design, Setting, and ParticipantsThe MoST-CIRCUIT prospective multicenter phase 2 nonrandomized clinical trial included patients with advanced selected rare cancers. Patients with advanced clear cell ovarian cancer (CCOC)/clear cell endometrial cancer (CCEC) with a maximum of 1 course of prior systemic therapy were enrolled from August 2021 to February 2024 across 17 Australian and New Zealand sites.InterventionsPatients received nivolumab, 3 mg/kg, and ipilimumab, 1 mg/kg, every 3 weeks for 4 doses followed by nivolumab, 480 mg, every 4 weeks for 96 weeks until disease progression or the development of unacceptable toxic effects.Main Outcomes and MeasuresCoprimary end points were objective response rate (ORR) and 6-month progression-free survival (PFS) as assessed by RECIST version 1.1 criteria, with the secondary end points being median overall survival, PFS, and treatment-related toxic effects.ResultsOf 28 included patients, the median (range) age was 55 (34-77) years. A total of 24 had CCOC and 4 had CCEC; 19 (68%) had a previous course of therapy. Overall ORR was 54% (95% CI, 35-71), with 3 (12%) with complete response and 12 (42%) with partial response; the ORR was 55% (95% CI, 35-73) in the CCOC group and 50% (95% CI, 9-91) in the CCEC group. The median duration of response has not been reached, with all responses ongoing. The 6-month PFS was 58% (95% CI, 39-74), and the median overall survival has not been reached. A total of 9 patients (35%) experienced a grade 3 or 4 immune-related adverse event, and a grade 5 myocarditis occurred in 1 patient.Conclusions and RelevanceIn this nonrandomized clinical trial, immunotherapy using combined anti-PD-1/CTLA-4 blockade demonstrated encouraging activity with a high rate of durable responses in patients with advanced gynecological CCCs. This regimen should be further investigated in this patient population with unmet medical need.Trial RegistrationClinicalTrials.gov Identifier: NCT04969887.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"199 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144547666","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}
引用次数: 0
Clearing the Path for Immunologic Targeting of Gynecologic Clear Cell Carcinomas. 为妇科透明细胞癌的免疫靶向扫清道路。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-03 DOI: 10.1001/jamaoncol.2025.1855
Yvette Drew,Michael A Bookman
{"title":"Clearing the Path for Immunologic Targeting of Gynecologic Clear Cell Carcinomas.","authors":"Yvette Drew,Michael A Bookman","doi":"10.1001/jamaoncol.2025.1855","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1855","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"48 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144547721","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}
引用次数: 0
Tongue Lesions While Undergoing Cancer Therapy. 接受癌症治疗时的舌头损伤。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-03 DOI: 10.1001/jamaoncol.2025.1864
Kendall Lin,Brittney Schultz,Arjun Gupta
{"title":"Tongue Lesions While Undergoing Cancer Therapy.","authors":"Kendall Lin,Brittney Schultz,Arjun Gupta","doi":"10.1001/jamaoncol.2025.1864","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1864","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"11 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144547722","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}
引用次数: 0
The Paradox of Data Sharing in Cancer Randomized Clinical Trials-A Call for Greater Transparency. 癌症随机临床试验数据共享的悖论——呼吁提高透明度。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-03 DOI: 10.1001/jamaoncol.2025.1984
Ludovic Trinquart,Martin R Stockler
{"title":"The Paradox of Data Sharing in Cancer Randomized Clinical Trials-A Call for Greater Transparency.","authors":"Ludovic Trinquart,Martin R Stockler","doi":"10.1001/jamaoncol.2025.1984","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1984","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"48 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144547728","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}
引用次数: 0
A Real-World Experience in Pan-Tumor Testing for HER2 IHC in More Than 65 000 Solid Tumors. 在超过65000个实体瘤中进行HER2 IHC泛肿瘤检测的真实世界经验。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-06-26 DOI: 10.1001/jamaoncol.2025.1791
Dave Bryant,Rebecca Feldman,Farah Abdulla,Daniel Magee,Jennifer R Ribeiro,Matthew Oberley,Milan Radovich,David Spetzler,George W Sledge
{"title":"A Real-World Experience in Pan-Tumor Testing for HER2 IHC in More Than 65 000 Solid Tumors.","authors":"Dave Bryant,Rebecca Feldman,Farah Abdulla,Daniel Magee,Jennifer R Ribeiro,Matthew Oberley,Milan Radovich,David Spetzler,George W Sledge","doi":"10.1001/jamaoncol.2025.1791","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1791","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"17 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144488071","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}
引用次数: 0
Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase 2 Nonrandomized Clinical Trial. 乌替龙加贝伐单抗治疗erbb2阴性转移性乳腺癌和活动性脑转移:U-BOMB 2期非随机临床试验
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-06-26 DOI: 10.1001/jamaoncol.2025.1694
Min Yan,Huimin Lv,Xinlan Liu,Shusen Wang,Cuizhi Geng,Yuhua Song,Zhenzhen Liu,Limin Niu,Mengwei Zhang,Chengzheng Wang,Yajing Feng,Huiai Zeng,Huihui Sun,Jing Wang,Yufen Xiang,Li Tang,Rongguo Qiu
{"title":"Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase 2 Nonrandomized Clinical Trial.","authors":"Min Yan,Huimin Lv,Xinlan Liu,Shusen Wang,Cuizhi Geng,Yuhua Song,Zhenzhen Liu,Limin Niu,Mengwei Zhang,Chengzheng Wang,Yajing Feng,Huiai Zeng,Huihui Sun,Jing Wang,Yufen Xiang,Li Tang,Rongguo Qiu","doi":"10.1001/jamaoncol.2025.1694","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.1694","url":null,"abstract":"ImportancePatients with ERBB2 (formerly HER2 or HER2/neu)-negative metastatic breast cancer (MBC) and brain metastases have poor prognosis, and effective treatment options are limited.ObjectiveTo investigate the activity and safety of utidelone plus bevacizumab in patients with ERBB2-negative MBC and active brain metastases.Design, Setting, and ParticipantsThis nonrandomized clinical trial was conducted at 5 hospitals in China. Adult patients with ERBB2-negative MBC who had untreated or progressive brain metastases were enrolled between May 5, 2022, and October 25, 2023. The data cutoff date was May 20, 2024; data were analyzed from September 15, 2022, to July 20, 2024.InterventionsPatients received bevacizumab (15 mg/kg on day 1) and utidelone (30 mg/m2 on days 1-5) every 3 weeks until disease progression or unacceptable toxic effects.Main Outcomes and MeasuresThe primary end point was central nervous system (CNS) objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.ResultsA total of 47 female patients (median age, 53 years [IQR, 45-59 years]) were recruited. Of these, 35 patients had untreated brain metastases and 12 had brain metastases that had progressed after local radiotherapy. The CNS ORR was 42.6% (95% CI, 28.3%-57.8%) per RECIST version 1.1 and 40.4% (95% CI, 26.4%-55.7%) per Response Assessment in Neuro-Oncology Brain Metastases criteria. The median follow-up duration was 11.0 months (range, 2.3-23.6 months). The median progression-free survival (PFS) was 7.7 months (95% CI, 5.6-9.7), median CNS-PFS was 10.6 months (95% CI, 8.4 months to not reached), and median overall survival was 15.1 months (95% CI, 12.0 months to not reached). The most common grade 3 or higher treatment-emergent adverse events were decreased lymphocyte count in 5 patients (10.6%) and decreased white blood cell count in 3 patients (6.4%). No serious or fatal adverse events occurred.Conclusions and RelevanceThe findings of this nonrandomized clinical trial suggest the potential of utidelone plus bevacizumab for the treatment of patients with ERBB2-negative MBC and active brain metastases. This treatment approach warrants further validation in a randomized clinical trial.Trial RegistrationClinicalTrials.gov Identifier: NCT05357417.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"18 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144488096","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}
引用次数: 0
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