JAMA Oncology最新文献

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Proportional Sedation for Persistent Agitated Delirium in Palliative Care 缓和治疗中持续躁动性谵妄的比例镇静
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-31 DOI: 10.1001/jamaoncol.2025.2212
David Hui, Allison De La Rosa, Jaw-Shiun Tsai, Shao-Yi Cheng, Egidio Del Fabbro, Anita Thankam Thomas Kuzhiyil, Kendra Rowe, Ahsan Azhar, Thuc Nguyen, Michael Tang, Chien-An Yao, Hsien-Liang Huang, Jen-Kuei Peng, Wen-Yu Hu, Sonal Admane, Rony Dev, Minxing Chen, Patricia Bramati, Sanjay Shete, Eduardo Bruera
{"title":"Proportional Sedation for Persistent Agitated Delirium in Palliative Care","authors":"David Hui, Allison De La Rosa, Jaw-Shiun Tsai, Shao-Yi Cheng, Egidio Del Fabbro, Anita Thankam Thomas Kuzhiyil, Kendra Rowe, Ahsan Azhar, Thuc Nguyen, Michael Tang, Chien-An Yao, Hsien-Liang Huang, Jen-Kuei Peng, Wen-Yu Hu, Sonal Admane, Rony Dev, Minxing Chen, Patricia Bramati, Sanjay Shete, Eduardo Bruera","doi":"10.1001/jamaoncol.2025.2212","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2212","url":null,"abstract":"ImportanceNeuroleptic and benzodiazepine medications are often considered for patients with persistent agitated delirium in the last days of life; however, the risk-to-benefit ratio of these medications is ill-defined and benzodiazepine medications have not been compared to placebo.ObjectiveTo compare the effect of scheduled haloperidol, lorazepam, haloperidol plus lorazepam, and placebo on patients with advanced cancer and delirium and experiencing restlessness and/or agitation in the palliative care setting.Design, Settings, and ParticipantsThis multicenter randomized clinical trial was conducted at 3 acute palliative care units in Taiwan and the US with patients with advanced cancer experiencing persistent restlessness and/or agitation despite nonpharmacologic therapies and standard-dose haloperidol. Among 245 eligible patients, 111 were enrolled, and 75 received blinded treatments. Participants were randomized in a 1:1:1:1 ratio (stratified by site and Richmond Agitation-Sedation Scale [RASS] score). The study period was from July 16, 2019, to June 8, 2023, with a 30-day follow-up after medication administration. Data analysis was performed from October 10, 2023, to April 11, 2025.InterventionsScheduled intravenous haloperidol, lorazepam, haloperidol plus lorazepam, or placebo every 4 hours until discharge, death, or withdrawal from study. Medications in all 4 groups had identical volume and appearance.Main Outcomes and MeasuresChange in RASS scores during the first 24 hours. Secondary outcomes included the use of rescue neuroleptics or benzodiazepines for breakthrough restlessness or agitation during the first 24 hours, delirium severity, perceived patient comfort, and adverse events.ResultsThe primary outcome was assessed in 72 patients (mean [SD] age, 64 [12] years, 42 male [58%]) with a median (IQR) MDAS score of 24 (18-29). The lorazepam group had significantly lower RASS scores than the haloperidol group (mean difference, −2.1; 95% CI, −3.4 to −0.9; <jats:italic>P</jats:italic> < .001) and the combination group had significantly lower RASS scores than the haloperidol group (−2.0; 95% CI, −3.2 to −0.8; <jats:italic>P</jats:italic> = .002); however, there was no difference observed between haloperidol and placebo groups (−0.5; 95% CI, −1.7 to 0.7; <jats:italic>P</jats:italic> = .42) nor between the combination and lorazepam groups (0.2; 95% CI, −1.1 to 1.4; <jats:italic>P</jats:italic> = .79). The combination and lorazepam groups required fewer rescue medications for breakthrough restlessness or agitation compared to the haloperidol and placebo groups (32%, 37%, 56%, 83%, respectively; <jats:italic>P</jats:italic> = .006). Adverse events or survival did not differ between groups.Conclusions and RelevanceThe results of this randomized clinical trial indicate that proactive use of scheduled sedatives, particularly lorazepam-based regimens, may reduce persistent restlessness and/or agitation in patients with advanced cancer and de","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"39 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144747753","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
Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor–Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy 替布西尼或安慰剂加氟维司汀在激素受体阳性和erbb2阴性晚期乳腺癌内分泌治疗后的疗效
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-31 DOI: 10.1001/jamaoncol.2025.2092
Zhonghua Tao, Jian Zhang, Qiufan Zheng, Yongsheng Wang, Li Cai, Hongyan Xu, Xinhua Xu, Xiangshun Kong, Sijuan Ding, Chunfang Hao, Hao Wang, Hong Zong, Xin Jin, Xinshuai Wang, Yang Li, Xiuli Yang, Weijie Li, Xiaoya Du, Hui Chen, Pengxiang Wu, Peiqi Li, Li Mao, Lieming Ding, Xichun Hu, Shusen Wang
{"title":"Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor–Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy","authors":"Zhonghua Tao, Jian Zhang, Qiufan Zheng, Yongsheng Wang, Li Cai, Hongyan Xu, Xinhua Xu, Xiangshun Kong, Sijuan Ding, Chunfang Hao, Hao Wang, Hong Zong, Xin Jin, Xinshuai Wang, Yang Li, Xiuli Yang, Weijie Li, Xiaoya Du, Hui Chen, Pengxiang Wu, Peiqi Li, Li Mao, Lieming Ding, Xichun Hu, Shusen Wang","doi":"10.1001/jamaoncol.2025.2092","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2092","url":null,"abstract":"ImportanceCyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) are now considered the standard treatment regimen for hormone receptor–positive (HR<jats:sup>+</jats:sup>) and <jats:italic>ERBB2 </jats:italic>(formerly <jats:italic>HER2</jats:italic>)–negative (<jats:italic>ERBB2</jats:italic><jats:sup>−</jats:sup>) advanced breast cancer (ABC). Tibremciclib (BPI-16350), a novel CDK4/6 inhibitor, has demonstrated favorable tolerability and promising antitumor activity as a monotherapy or combined with fulvestrant among patients with HR<jats:sup>+</jats:sup>/<jats:italic>ERBB2</jats:italic><jats:sup>−</jats:sup> ABC in a phase 1 trial. Further investigations are necessary to assess the efficacy and safety of tibremciclib.ObjectiveTo compare tibremciclib plus fulvestrant and placebo plus fulvestrant in terms of efficacy and safety among patients with HR<jats:sup>+</jats:sup>/<jats:italic>ERBB2</jats:italic><jats:sup>−</jats:sup> ABC who exhibited disease progression after ET.Design, Setting, and ParticipantsThe TIFFANY trial was a double-blind, placebo-controlled, phase 3 randomized clinical trial of patients with HR<jats:sup>+</jats:sup>/<jats:italic>ERBB2</jats:italic><jats:sup>−</jats:sup> ABC who had experienced progression while receiving prior ET and had received no more than 1 line of chemotherapy. This trial was conducted at 69 Chinese centers between May 25, 2022, and April 25, 2023. The data cutoff date for this analysis was March 31, 2024.InterventionsPatients were randomly assigned to receive tibremciclib (400 mg, orally, once daily) plus fulvestrant or placebo plus fulvestrant at a 2:1 ratio until disease progression, death, or treatment discontinuation for various reasons.Main Outcomes and MeasuresThe primary end point was investigator-assessed progression-free survival (PFS), and the secondary end points included the objective response rate, overall survival, and safety.ResultsA total of 274 female patients (median [IQR] age, 53.0 [46.0-60.0] years) were randomly assigned to receive tibremciclib plus fulvestrant (184 [67.2%]) or placebo plus fulvestrant (90 [32.8%]). Among these patients, 144 PFS events occurred (80 in the tibremciclib arm and 64 in the placebo arm), with a median follow-up of 12.9 months for both arms. Tibremciclib plus fulvestrant significantly improved PFS compared with placebo plus fulvestrant (median, 16.5 months [95% CI, 12.8-16.6] vs 5.6 months [95% CI, 4.5-9.2]; hazard ratio, 0.37; 95% CI, 0.27-0.52; <jats:italic>P</jats:italic> < .001). In patients with measurable disease, tibremciclib plus fulvestrant achieved an objective response rate of 45.6% (95% CI, 37.6%-53.7%) compared with 12.9% (95% CI, 6.1%-23.0%) in the placebo arm (<jats:italic>P</jats:italic> < .001). The most common grade 3 or higher treatment-emergent adverse events in the tibremciclib vs placebo arm were neutropenia (15.2% vs 5.6%, respectively), anemia (12.0% vs 4.4%, respectively), and hypok","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"65 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144747749","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
Grade Group 1 Prostate Cancer Outcome by Biopsy Grade and Risk Group 前列腺癌预后按活检分级和危险组划分
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-31 DOI: 10.1001/jamaoncol.2025.2304
Neal A. Patel, Daniel A. Barocas, Daniel W. Lin, Xian Wu, David Green, Kevin H. Kensler, Jonathan Shoag, Bashir Al Hussein Al Awamlh
{"title":"Grade Group 1 Prostate Cancer Outcome by Biopsy Grade and Risk Group","authors":"Neal A. Patel, Daniel A. Barocas, Daniel W. Lin, Xian Wu, David Green, Kevin H. Kensler, Jonathan Shoag, Bashir Al Hussein Al Awamlh","doi":"10.1001/jamaoncol.2025.2304","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2304","url":null,"abstract":"ImportanceAdvocates for removing the cancer label from grade group 1 (GG1) prostate cancer detected on biopsy primarily base their argument on the observation that when only GG1 is detected on prostatectomy, rates of metastasis are rare. However, the frequency with which GG1 prostate cancer on biopsy is associated with adverse clinical features and the long-term cancer outcomes in this context are poorly defined.ObjectiveTo assess cancer-specific outcomes of localized GG1 prostate cancer stratified by risk category.Design, Setting, and ParticipantsA population-based cohort study using Surveillance, Epidemiology, and End Results data was performed to assess cancer-specific outcomes in 117 162 men with localized GG1 prostate cancer stratified by National Comprehensive Cancer Network risk groups between January 1, 2010, and December 31, 2020. Competing risk analyses and multivariable regression determined rates of prostate cancer–specific mortality and associations with prostatectomy adverse pathology. Data were analyzed from July 1, 2024, to October 1, 2024.Main OutcomesProstate cancer–specific mortality and risk of adverse pathology at surgery in GG1 prostate cancer.ResultsAmong 117 162 men with biopsy GG1 prostate cancer, 10 440 (9%) had favorable intermediate-risk disease, 3145 (3%) had unfavorable intermediate-risk disease, and 4539 (4%) had high-risk disease. Median age was 64 years (IQR, 58-69 years). A total of 867 men with high-risk GG1 prostate cancer (60%) had adverse pathology at prostatectomy. The prostate cancer–specific mortality rates for unfavorable intermediate-risk GG1 and for high-risk GG1 were 2.4% and 4.7%, respectively, comparable to the prostate cancer–specific mortality rates for favorable intermediate-risk GG2 and unfavorable intermediate-risk greater than or equal to GG2, which were 2.1% and 4.0%, respectively. In adjusted analyses, favorable intermediate-risk GG1 (adjusted hazard ratio [AHR], 1.60; 95% CI, 1.30-1.96), unfavorable intermediate-risk GG1 (AHR, 2.10; 95% CI, 1.53-2.89), and high-risk GG1 (AHR, 3.58; 95% CI, 2.93-4.38) were associated with increased risk of prostate cancer–specific mortality compared with low-risk GG1.Conclusions and RelevanceThis cohort study found that approximately 1 in 6 men with GG1 prostate cancer has intermediate-risk or high-risk disease. Biopsy GG1 prostate cancer has heterogeneous long-term outcomes that are reflected in adverse pathology and prostate cancer–specific mortality. These data indicate that not all GG1 prostate cancer follows an indolent course. A subset of men with biopsy GG1 prostate cancer have outcomes comparable to those of men with higher-grade intermediate-risk prostate cancer, a group that often undergoes treatment. These findings should be considered in the reclassification debate.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"14 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144747827","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
Challenges and Opportunities for the US Oncology Workforce 美国肿瘤工作人员面临的挑战和机遇
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-31 DOI: 10.1001/jamaoncol.2025.2331
Lawrence N. Shulman, Hedvig Hricak, S. Gail Eckhardt
{"title":"Challenges and Opportunities for the US Oncology Workforce","authors":"Lawrence N. Shulman, Hedvig Hricak, S. Gail Eckhardt","doi":"10.1001/jamaoncol.2025.2331","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2331","url":null,"abstract":"This Viewpoint discusses potential challenges facing the US oncology workforce in light of growing gaps between patients with cancer and the number of oncology clinicians.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"75 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144747747","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
Concerns About Conclusions of the POLAR Trial. 对POLAR试验结论的关注。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-31 DOI: 10.1001/jamaoncol.2025.2355
Lise Ventzel,Jordi Bruna,Guido Cavaletti
{"title":"Concerns About Conclusions of the POLAR Trial.","authors":"Lise Ventzel,Jordi Bruna,Guido Cavaletti","doi":"10.1001/jamaoncol.2025.2355","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2355","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"8 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144747752","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
Five Years After Pathologic Complete Response Without Surgery. 无手术病理完全缓解后5年。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-24 DOI: 10.1001/jamaoncol.2025.2123
Zemin Tian,Yinde Huang,Yuan Qiu
{"title":"Five Years After Pathologic Complete Response Without Surgery.","authors":"Zemin Tian,Yinde Huang,Yuan Qiu","doi":"10.1001/jamaoncol.2025.2123","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2123","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"32 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693273","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
Defining Lifetime Risk Thresholds for Breast Cancer Surgical Prevention. 确定乳腺癌手术预防的终生风险阈值。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-24 DOI: 10.1001/jamaoncol.2025.2203
Xia Wei,Lea Mansour,Samuel Oxley,Caitlin T Fierheller,Ashwin Kalra,Jacqueline Sia,Subhasheenee Ganesan,Michail Sideris,Li Sun,Adam Brentnall,Stephen Duffy,D Gareth Evans,Li Yang,Rosa Legood,Ranjit Manchanda
{"title":"Defining Lifetime Risk Thresholds for Breast Cancer Surgical Prevention.","authors":"Xia Wei,Lea Mansour,Samuel Oxley,Caitlin T Fierheller,Ashwin Kalra,Jacqueline Sia,Subhasheenee Ganesan,Michail Sideris,Li Sun,Adam Brentnall,Stephen Duffy,D Gareth Evans,Li Yang,Rosa Legood,Ranjit Manchanda","doi":"10.1001/jamaoncol.2025.2203","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2203","url":null,"abstract":"ImportanceExpanding access to genetic testing and availability of validated breast cancer (BC) risk prediction models are increasingly identifying women at elevated BC risk who do not carry high-penetrance BRCA1/BRCA2/PALB2 pathogenic variants. The precise BC risk threshold for offering risk-reducing mastectomy (RRM) for BC prevention is unknown.ObjectiveTo define the lifetime BC risk thresholds for RRM to be cost-effective compared with nonsurgical alternatives for BC prevention.Design, Setting, and ParticipantsThis economic evaluation used a decision-analytic Markov model to compare the cost-effectiveness of RRM with BC screening and medical prevention in a simulated cohort. Extensive sensitivity analyses were performed. The study setting was from a UK payer perspective over a lifetime horizon until age 80 years. The simulated cohort included women aged 30 to 60 years at varying lifetime BC risks from 17% to 50%. The study was conducted between September 2022 and September 2024.ExposuresUndergoing RRM or receiving risk-stratified BC screening with medical prevention (tamoxifen or anastrozole).Main Outcomes and MeasuresThe incremental cost-effectiveness ratio was calculated as incremental cost per quality-adjusted life-year (QALY) gained and compared with the UK willingness-to-pay (WTP) threshold of £20 000 (US $27 037) to £30 000 (US $40 555) per QALY. BC cases prevented were estimated at the population level.ResultsIn the simulated cohort of 100 000 thirty-year-old women in the UK, undergoing RRM became cost-effective at a 34% lifetime BC risk using the £30 000 (US $40 555) per QALY WTP threshold. This increased to a 42% lifetime BC risk using the £20 000 (US $27 037) per QALY WTP threshold. The identified lifetime BC risk thresholds for RRM to be cost-effective among women aged 35, 40, 45, 50, 55, and 60 years were 31%, 29%, 29%, 32%, 36%, and 42%, respectively, using the £30 000 (US $40 555) per QALY WTP threshold. Overall, undergoing RRM was deemed cost-effective for women aged 30 to 55 years with a lifetime BC risk of at least 35%, with more than 50% of simulations being cost-effective in probabilistic sensitivity analysis. Offering RRM for women with a lifetime BC risk of 35% or higher could potentially prevent approximately 6538 (95% CI, 4454-7041), or approximately 11% (95% CI, 8%-12%), of the 58 756 BC cases occurring annually in women in the UK. In the probabilistic sensitivity analysis, 20.71% to 59.96%, 44.04% to 81.29%, and 97.26% to 99.35% of simulations were cost-effective for women with 35%, 40%, and 50% lifetime BC-risk undergoing RRM at age 30 under the £20 000 to £30 000 per QALY WTP threshold, respectively.Conclusions and RelevanceIn this economic evaluation, undergoing RRM appears cost-effective for women aged 30 to 55 years with a lifetime BC risk of 35% or higher. These results could have significant clinical implications to expand access to RRM beyond BRCA1/BRCA2/PALB2 pathogenic variant carriers. Future studies evaluati","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"143 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693269","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
Five Years After Pathologic Complete Response Without Surgery-Reply. 病理完全缓解后5年无手术-回复。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-24 DOI: 10.1001/jamaoncol.2025.2126
Henry M Kuerer
{"title":"Five Years After Pathologic Complete Response Without Surgery-Reply.","authors":"Henry M Kuerer","doi":"10.1001/jamaoncol.2025.2126","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2126","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"14 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693272","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
Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. 序贯与诱导+同步放化疗在鼻咽癌中的应用:一项随机临床试验。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-24 DOI: 10.1001/jamaoncol.2025.2191
Fen Xue,Dan Ou,Congying Xie,Shaojun Lin,Jingao Li,Xiaozhong Chen,Fuzheng Zhang,Hongmei Ying,Xueguan Lu,Chunying Shen,Tingting Xu,Xiaomin Ou,Weiwei Li,Xin Zhou,Chengrun Du,Changming Zhou,Chaosu Hu,Xiayun He
{"title":"Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial.","authors":"Fen Xue,Dan Ou,Congying Xie,Shaojun Lin,Jingao Li,Xiaozhong Chen,Fuzheng Zhang,Hongmei Ying,Xueguan Lu,Chunying Shen,Tingting Xu,Xiaomin Ou,Weiwei Li,Xin Zhou,Chengrun Du,Changming Zhou,Chaosu Hu,Xiayun He","doi":"10.1001/jamaoncol.2025.2191","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.2191","url":null,"abstract":"ImportanceInduction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) has been a standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC) but with high acute toxic effects in CCRT phase. Whether CCRT can be safely replaced by radiation therapy with adjuvant chemotherapy (AC) is unknown.ObjectiveTo assess if sequential chemoradiotherapy (SCRT; IC, followed by radiotherapy alone, followed by AC) is noninferior to IC plus CCRT for LA-NPC in terms of efficacy, with less acute toxic effects.Design, Setting, and ParticipantsThis multicenter, open-label, phase 3 noninferiority randomized clinical trial was conducted from January 2018 to September 2021 in 6 centers in China. Patients aged 18 to 65 years with newly diagnosed stage III/IVA NPC were enrolled. The data cutoff date was June 30, 2024.InterventionsPatients were randomly assigned 1:1 to receive 2 cycles of IC with a gemcitabine and cisplatin (GP) regimen (gemcitabine, 1000 mg/m2, on days 1 and 8 plus cisplatin, 25 mg/m2, on days 1, 2, and 3, repeated every 3 weeks) plus radiotherapy alone, followed by 2 cycles of AC with a GP regimen (SCRT group) or 2 cycles IC (GP regimen) followed by radiotherapy concurrent with weekly cisplatin, 30 mg/m2 (IC plus CCRT group).Main Outcomes and MeasuresThe primary end points were 3-year failure-free survival (FFS) with a noninferiority margin of 10% (hazard ratio [HR] less than 1.6) and the incidence of grade 3 or higher acute mucositis during radiotherapy. The secondary end points included overall survival, locoregional FFS, distant FFS, response rate, and toxic effects.ResultsOf 420 enrolled patients, 107 (25.5%) were women, and the median (IQR) age was 48 (41-54) years. A total of 210 patients were randomized to the SCRT group and 210 to the IC plus CCRT group. The median (IQR) follow-up time was 50 (40-61) months. In the intention-to-treat population, 3-year FFS was 83.7% (95% CI, 78.6-88.8) vs 79.5% (95% CI, 74.0-85.0) in the SCRT group vs the IC plus CCRT group, respectively (HR, 0.77; 95% CI, 0.50-1.19; P = .24), with the upper bound of the 95% CI less than 1.6. Identical outcomes were reported in the per-protocol population. Compared with the IC plus CCRT group, the SCRT group had significantly lower incidences of grade 3 or higher acute nonhematological toxic effects (acute mucositis, 61 [29.0%] vs 88 [41.9%], respectively; P < .001; nausea, 20 [9.5%] vs 38[18.1%], respectively; P = .01; vomiting, 8 [3.8%] vs 20 [9.5%], respectively; P = .02). No differences were observed in late toxic effects.Conclusions and RelevanceResults from this noninferiority randomized clinical trial suggest that SCRT is noninferior to IC plus CCRT in terms of 3-year FFS in LA-NPC, with less severe acute nonhematological toxic effects.Trial RegistrationClinicalTrials.gov Identifier: NCT03366415.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"12 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693271","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
Redefining Systemic Therapy Timing in Nasopharyngeal Cancer-Before, During, or After Radiation. 重新定义鼻咽癌放疗前、放疗中和放疗后的全身治疗时机。
IF 28.4 1区 医学
JAMA Oncology Pub Date : 2025-07-24 DOI: 10.1001/jamaoncol.2025.2171
Alisa Rybkin,Aarti Bhatia,Henry S Park
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