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Risk Prediction Model for Development of Heart Failure or Cardiomyopathy After Breast Cancer Treatment. 乳腺癌治疗后发生心力衰竭或心肌病的风险预测模型。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-23 DOI: 10.1001/jamaoncol.2025.4178
Ana Barac,Jiling Chou,Nawar Shara,Lie H Chen,Jiaxiao Shi,Rowan T Chlebowski,Amrita Mukherjee,Reina Haque,Arnold L Potosky
ImportanceWomen receiving breast cancer (BC) treatment are at risk for heart failure or cardiomyopathy (HF/CM). No standard method exists to identify women at risk who might benefit from preventive cardiac strategies and surveillance during and after treatment.ObjectiveTo develop and validate a model predicting the 10-year risk of developing HF/CM in women receiving systemic treatment for invasive early-stage BC to inform cardiac risk management.Design, Setting, and ParticipantsThis longitudinal cohort study of patients cared for in Kaiser Permanente Southern California, a vertically integrated health care system. The goal of the study was to predict the 10-year HF/CM risk using multivariable elastic-net Cox proportional hazards models. Women aged 18 to 79 years with newly diagnosed invasive local or regional BC from 2008 to 2020, with a median follow-up of 5.2 years, were included. The cohort was randomly split into derivation (60%) and validation (40%) cohorts. Data were analyzed from April 2024 to May 2025.ExposuresHF/CM risk predictors included age at BC diagnosis, race and ethnicity, area-level socioeconomic status, local and systemic BC treatments, cancer stage, obesity, and history of hypertension, diabetes, hyperlipidemia, smoking, and other CV conditions.Main Outcome and MeasuresIncident HF/CM events. Women were categorized into low-, moderate-, and high-risk groups based on the tertiles of the risk score in the derivation cohort.ResultsOf 26 044 women included in the total cohort, the median (IQR) age was 61 (52-68) years. The risk model had good calibration and high accuracy in predicting HF/CM risk in the 3 subgroups, with HF/CM risk in the validation cohort matching the estimates from the derivation for identifying women at low risk (1.7%; 95% CI, 1.1%-2.4%) and high risk (19.4%; 95% CI. 17.3%-21.5%) of HF/CM at 10 years. The model's discrimination ability was good, based on the time-dependent area under the curve of 0.79 at 10 years in the validation cohort.Conclusions and RelevanceThis risk prediction model among women with early-stage BC was able to prospectively identify those at risk of HF/CM over a 10-year period based on the selected BC treatment and clinical variables available at BC diagnosis. The model can be used to inform risk-guided cardiac management for these women.
接受乳腺癌(BC)治疗的女性有发生心力衰竭或心肌病(HF/CM)的风险。目前还没有标准的方法来确定有风险的妇女,她们可能从治疗期间和治疗后的预防性心脏策略和监测中受益。目的建立并验证一个模型,预测接受有创性早期BC全身治疗的女性发生HF/CM的10年风险,为心脏风险管理提供信息。设计、环境和参与者:本纵向队列研究对Kaiser Permanente南加利福尼亚(一个垂直整合的医疗保健系统)的患者进行了研究。该研究的目的是使用多变量弹性净Cox比例风险模型预测10年HF/CM风险。研究纳入了2008年至2020年新诊断为浸润性局部或区域性BC的18至79岁女性,中位随访时间为5.2年。该队列随机分为衍生队列(60%)和验证队列(40%)。数据分析时间为2024年4月至2025年5月。shf /CM的风险预测因素包括BC诊断时的年龄、种族和民族、地区社会经济地位、局部和全身BC治疗、癌症分期、肥胖、高血压、糖尿病、高脂血症、吸烟史和其他心血管疾病。主要结局和测量:HF/CM事件。根据衍生队列中风险评分的位数,将妇女分为低、中、高风险组。结果26 044名女性纳入总队列,中位(IQR)年龄为61(52-68)岁。该风险模型在预测3个亚组的HF/CM风险方面具有良好的校准和较高的准确性,验证队列中的HF/CM风险与鉴别低风险女性(1.7%;95% CI, 1.1%-2.4%)和高风险女性(19.4%;95% CI)的推导结果相匹配。17.3% ~ 21.5%)。在验证队列中,10年曲线下的时间依赖面积为0.79,模型的识别能力较好。结论和相关性:基于所选择的BC治疗方法和BC诊断时可用的临床变量,该早期BC女性的风险预测模型能够在10年内前瞻性地识别出HF/CM风险。该模型可用于这些妇女的风险指导心脏管理。
{"title":"Risk Prediction Model for Development of Heart Failure or Cardiomyopathy After Breast Cancer Treatment.","authors":"Ana Barac,Jiling Chou,Nawar Shara,Lie H Chen,Jiaxiao Shi,Rowan T Chlebowski,Amrita Mukherjee,Reina Haque,Arnold L Potosky","doi":"10.1001/jamaoncol.2025.4178","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.4178","url":null,"abstract":"ImportanceWomen receiving breast cancer (BC) treatment are at risk for heart failure or cardiomyopathy (HF/CM). No standard method exists to identify women at risk who might benefit from preventive cardiac strategies and surveillance during and after treatment.ObjectiveTo develop and validate a model predicting the 10-year risk of developing HF/CM in women receiving systemic treatment for invasive early-stage BC to inform cardiac risk management.Design, Setting, and ParticipantsThis longitudinal cohort study of patients cared for in Kaiser Permanente Southern California, a vertically integrated health care system. The goal of the study was to predict the 10-year HF/CM risk using multivariable elastic-net Cox proportional hazards models. Women aged 18 to 79 years with newly diagnosed invasive local or regional BC from 2008 to 2020, with a median follow-up of 5.2 years, were included. The cohort was randomly split into derivation (60%) and validation (40%) cohorts. Data were analyzed from April 2024 to May 2025.ExposuresHF/CM risk predictors included age at BC diagnosis, race and ethnicity, area-level socioeconomic status, local and systemic BC treatments, cancer stage, obesity, and history of hypertension, diabetes, hyperlipidemia, smoking, and other CV conditions.Main Outcome and MeasuresIncident HF/CM events. Women were categorized into low-, moderate-, and high-risk groups based on the tertiles of the risk score in the derivation cohort.ResultsOf 26 044 women included in the total cohort, the median (IQR) age was 61 (52-68) years. The risk model had good calibration and high accuracy in predicting HF/CM risk in the 3 subgroups, with HF/CM risk in the validation cohort matching the estimates from the derivation for identifying women at low risk (1.7%; 95% CI, 1.1%-2.4%) and high risk (19.4%; 95% CI. 17.3%-21.5%) of HF/CM at 10 years. The model's discrimination ability was good, based on the time-dependent area under the curve of 0.79 at 10 years in the validation cohort.Conclusions and RelevanceThis risk prediction model among women with early-stage BC was able to prospectively identify those at risk of HF/CM over a 10-year period based on the selected BC treatment and clinical variables available at BC diagnosis. The model can be used to inform risk-guided cardiac management for these women.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"136 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145339191","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
Power Limits in Body Mass Index, Activity, and Cancer Risk. 身体质量指数、运动和癌症风险的能量限制。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-23 DOI: 10.1001/jamaoncol.2025.4172
Lanwei Guo
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引用次数: 0
Power Limits in Body Mass Index, Activity, and Cancer Risk-Reply. 身体质量指数、运动和癌症风险反应的能量限制。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-23 DOI: 10.1001/jamaoncol.2025.4175
Lenat Joffe,Sedigheh Mirzaei,Lucie M Turcotte
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引用次数: 0
National Trends in Dexrazoxane and Cardiovascular Health Care Utilization for Children With Acute Myeloid Leukemia. 急性髓性白血病儿童右拉唑烷与心血管保健应用的全国趋势
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-23 DOI: 10.1001/jamaoncol.2025.4365
Daniel J Zheng,Gary Hettinger,Jonathan D Bender,Alexis C Boulter,Lusha Cao,Caitlin W Elgarten,Brian T Fisher,Cody Gathers,Yuan-Shung V Huang,Jennifer Ko,Kasey J Leger,Yimei Li,Regina Myers,Hari K Narayan,Jose Ortiz,Alix E Seif,Eleana Vasileiadi,Richard Aplenc,Kelly D Getz
{"title":"National Trends in Dexrazoxane and Cardiovascular Health Care Utilization for Children With Acute Myeloid Leukemia.","authors":"Daniel J Zheng,Gary Hettinger,Jonathan D Bender,Alexis C Boulter,Lusha Cao,Caitlin W Elgarten,Brian T Fisher,Cody Gathers,Yuan-Shung V Huang,Jennifer Ko,Kasey J Leger,Yimei Li,Regina Myers,Hari K Narayan,Jose Ortiz,Alix E Seif,Eleana Vasileiadi,Richard Aplenc,Kelly D Getz","doi":"10.1001/jamaoncol.2025.4365","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.4365","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"51 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145339190","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
Can We Use Credit Data to Assess Cancer Financial Hardship? 我们可以使用信用数据来评估癌症的财务困难吗?
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-23 DOI: 10.1001/jamaoncol.2025.4371
Christopher T Su,Scott D Ramsey,Veena Shankaran
{"title":"Can We Use Credit Data to Assess Cancer Financial Hardship?","authors":"Christopher T Su,Scott D Ramsey,Veena Shankaran","doi":"10.1001/jamaoncol.2025.4371","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.4371","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"43 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145339192","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
Unexpected Results of Induction Chemotherapy vs Adjuvant Chemotherapy. 诱导化疗与辅助化疗的意外结果。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-16 DOI: 10.1001/jamaoncol.2025.4092
Melvin L K Chua,Darren W T Lim
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引用次数: 0
Artificial Intelligence-Detected Tumor-Infiltrating Lymphocytes and Outcomes in Anti-PD-1-Based Treated Melanoma. 人工智能检测肿瘤浸润淋巴细胞和抗pd -1治疗黑色素瘤的结果。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-16 DOI: 10.1001/jamaoncol.2025.4072
Mark Schuiveling,Isabella A J van Duin,Laurens S Ter Maat,Janneke C van der Weerd,Rik J Verheijden,Franchette van den Berkmortel,Christian U Blank,Gerben E Breimer,Femke H Burgers,Marye Boers-Sonderen,Alfons J M van den Eertwegh,Jan Willem B de Groot,John B A G Haanen,Geke A P Hospers,Ellen Kapiteijn,Djura Piersma,Gerard Vreugdenhil,Hans Westgeest,Anne M R Schrader,Josien P W Pluim,Paul J van Diest,Mitko Veta,Karijn P M Suijkerbuijk,Willeke A M Blokx
ImportanceEasy and accessible biomarkers associated with response to immune checkpoint inhibition (ICI)-treated melanoma are limited.ObjectiveTo evaluate artificial intelligence (AI)-detected tumor-infiltrating lymphocytes (TILs) on pretreatment melanoma metastases as a biomarker for response and survival in patients treated with ICIs.Design, Setting, and ParticipantsThis multicenter cohort study included patients with advanced melanoma treated with first-line anti-programmed cell death 1 protein (PD-1) with or without anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) between January 2016 and January 2023 at 11 melanoma treatment centers in the Netherlands. Data were analyzed from January to July 2025.ExposureAll patients received first-line anti-PD-1 with or without anti-CTLA-4.Main Outcomes and MeasuresThe percentage of TILs inside manually annotated tumor area in hematoxylin-eosin-stained pretreatment metastases was determined using the Hover-NeXt model trained and evaluated on an independent melanoma dataset containing 161 835 pathologist-verified manually annotated cells. The primary outcome was objective response rate (ORR); secondary outcomes were progression-free survival (PFS) and overall survival (OS). Correlation with manual TILs, scored according to the guidelines stated by the Immuno-Oncology Biomarkers Working Group, was evaluated with Spearman correlation coefficients. Logistic regression and Cox proportional regression were conducted, adjusted for age, sex, disease stage, ICI type, BRAF status, brain metastases, lactate dehydrogenase level, and performance status.ResultsOf 1202 included patients with advanced cutaneous melanoma, 445 (37.0%) were female and 757 (63.0%) were male, and the median (IQR) age was 67.0 (57.0-74.0) years. The median follow-up was 36.3 months (95% CI, 34.0-39.1). Metastatic melanoma specimens were available for 1202 patients, of whom 423 received combination therapy. The median (range) TIL percentage was 9.9% (0.3%-69.4%). A 10% increase in TILs was associated with increased ORR (adjusted odds ratio, 1.40; 95% CI, 1.23-1.59), PFS (adjusted hazard ratio, 0.85; 95% CI, 0.79-0.92), and OS (adjusted hazard ratio, 0.83; 95% CI, 0.76-0.91). Results were consistent for both patients treated with anti-PD-1 monotherapy and patients treated with combination treatment with anti-PD-1 plus anti-CTLA-4. When comparing manual TIL scoring with AI-detected TILs, associations with response and survival were consistently stronger for AI-detected TILs.Conclusions and RelevanceIn this cohort study, among patients with advanced melanoma, higher levels of AI-detected TILs on pretreatment hematoxylin-eosin slides were independently associated with improved ICI response and survival. Given the accessibility of TIL scoring on routine histology, TILs may serve as a biomarker for ICI outcomes. To facilitate broader validation, the Hover-NeXt architecture and model weights are publicly available.
与免疫检查点抑制(ICI)治疗的黑色素瘤反应相关的生物标志物是有限的。目的评价人工智能(AI)检测肿瘤浸润淋巴细胞(TILs)在黑色素瘤转移前治疗中的作用,并将其作为影响ICIs治疗患者反应和生存的生物标志物。设计、环境和参与者这项多中心队列研究纳入了2016年1月至2023年1月期间荷兰11个黑色素瘤治疗中心接受一线抗程序性细胞死亡1蛋白(PD-1)联合或不联合抗细胞毒性t淋巴细胞相关蛋白4 (CTLA-4)治疗的晚期黑色素瘤患者。数据分析时间为2025年1月至7月。所有患者均接受一线抗pd -1治疗,同时或不同时接受抗ctla -4治疗。在苏木精-伊红染色的前处理转移瘤中,人工注释肿瘤区域内TILs的百分比使用Hover-NeXt模型进行确定,该模型在包含161 835个经病理学家验证的人工注释细胞的独立黑色素瘤数据集上进行训练和评估。主要终点为客观缓解率(ORR);次要终点是无进展生存期(PFS)和总生存期(OS)。与手动TILs的相关性,根据免疫肿瘤学生物标志物工作组的指南评分,用Spearman相关系数进行评估。进行Logistic回归和Cox比例回归,调整年龄、性别、疾病分期、ICI类型、BRAF状态、脑转移、乳酸脱氢酶水平和工作表现状态。结果1202例晚期皮肤黑色素瘤患者中,女性445例(37.0%),男性757例(63.0%),中位年龄(IQR)为67.0(57.0 ~ 74.0)岁。中位随访时间为36.3个月(95% CI, 34.0-39.1)。1202例患者获得了转移性黑色素瘤标本,其中423例接受了联合治疗。TIL百分比中位数(范围)为9.9%(0.3%-69.4%)。TILs增加10%与ORR(校正优势比,1.40;95% CI, 1.23-1.59)、PFS(校正风险比,0.85;95% CI, 0.79-0.92)和OS(校正风险比,0.83;95% CI, 0.76-0.91)增加相关。抗pd -1单药治疗和抗pd -1 +抗ctla -4联合治疗的患者结果一致。当将人工TIL评分与人工智能检测的TIL进行比较时,人工智能检测的TIL与反应和生存的相关性始终更强。结论和相关性在这项队列研究中,在晚期黑色素瘤患者中,预处理苏木精-伊红载玻片上ai检测到较高水平的TILs与改善的ICI反应和生存率独立相关。考虑到TIL评分在常规组织学上的可及性,TIL可以作为ICI结果的生物标志物。为了便于更广泛的验证,Hover-NeXt架构和模型权重是公开的。
{"title":"Artificial Intelligence-Detected Tumor-Infiltrating Lymphocytes and Outcomes in Anti-PD-1-Based Treated Melanoma.","authors":"Mark Schuiveling,Isabella A J van Duin,Laurens S Ter Maat,Janneke C van der Weerd,Rik J Verheijden,Franchette van den Berkmortel,Christian U Blank,Gerben E Breimer,Femke H Burgers,Marye Boers-Sonderen,Alfons J M van den Eertwegh,Jan Willem B de Groot,John B A G Haanen,Geke A P Hospers,Ellen Kapiteijn,Djura Piersma,Gerard Vreugdenhil,Hans Westgeest,Anne M R Schrader,Josien P W Pluim,Paul J van Diest,Mitko Veta,Karijn P M Suijkerbuijk,Willeke A M Blokx","doi":"10.1001/jamaoncol.2025.4072","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.4072","url":null,"abstract":"ImportanceEasy and accessible biomarkers associated with response to immune checkpoint inhibition (ICI)-treated melanoma are limited.ObjectiveTo evaluate artificial intelligence (AI)-detected tumor-infiltrating lymphocytes (TILs) on pretreatment melanoma metastases as a biomarker for response and survival in patients treated with ICIs.Design, Setting, and ParticipantsThis multicenter cohort study included patients with advanced melanoma treated with first-line anti-programmed cell death 1 protein (PD-1) with or without anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) between January 2016 and January 2023 at 11 melanoma treatment centers in the Netherlands. Data were analyzed from January to July 2025.ExposureAll patients received first-line anti-PD-1 with or without anti-CTLA-4.Main Outcomes and MeasuresThe percentage of TILs inside manually annotated tumor area in hematoxylin-eosin-stained pretreatment metastases was determined using the Hover-NeXt model trained and evaluated on an independent melanoma dataset containing 161 835 pathologist-verified manually annotated cells. The primary outcome was objective response rate (ORR); secondary outcomes were progression-free survival (PFS) and overall survival (OS). Correlation with manual TILs, scored according to the guidelines stated by the Immuno-Oncology Biomarkers Working Group, was evaluated with Spearman correlation coefficients. Logistic regression and Cox proportional regression were conducted, adjusted for age, sex, disease stage, ICI type, BRAF status, brain metastases, lactate dehydrogenase level, and performance status.ResultsOf 1202 included patients with advanced cutaneous melanoma, 445 (37.0%) were female and 757 (63.0%) were male, and the median (IQR) age was 67.0 (57.0-74.0) years. The median follow-up was 36.3 months (95% CI, 34.0-39.1). Metastatic melanoma specimens were available for 1202 patients, of whom 423 received combination therapy. The median (range) TIL percentage was 9.9% (0.3%-69.4%). A 10% increase in TILs was associated with increased ORR (adjusted odds ratio, 1.40; 95% CI, 1.23-1.59), PFS (adjusted hazard ratio, 0.85; 95% CI, 0.79-0.92), and OS (adjusted hazard ratio, 0.83; 95% CI, 0.76-0.91). Results were consistent for both patients treated with anti-PD-1 monotherapy and patients treated with combination treatment with anti-PD-1 plus anti-CTLA-4. When comparing manual TIL scoring with AI-detected TILs, associations with response and survival were consistently stronger for AI-detected TILs.Conclusions and RelevanceIn this cohort study, among patients with advanced melanoma, higher levels of AI-detected TILs on pretreatment hematoxylin-eosin slides were independently associated with improved ICI response and survival. Given the accessibility of TIL scoring on routine histology, TILs may serve as a biomarker for ICI outcomes. To facilitate broader validation, the Hover-NeXt architecture and model weights are publicly available.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"47 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145296087","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
Radiotherapy With a 12-Gene Expression Assay for Ductal Carcinoma In Situ: A Randomized Clinical Trial. 12基因表达法放射治疗导管原位癌:一项随机临床试验。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-16 DOI: 10.1001/jamaoncol.2025.4079
Seema A Khan,Justin Romanoff,Constantine Gatsonis,Habib Rahbar,Ruth Carlos,Sunil Badve,Jean Wright,Ralph L Corsetti,Constance D Lehman,Derrick W Spell,Linda K Han,John R Bumberry,Ilana Gareen,Bradley S Snyder,Lynne I Wagner,Kathy D Miller,Christopher Comstock,Joseph A Sparano
ImportanceBreast ductal carcinoma in situ (DCIS) requires personalized treatment given its variable natural history. This study reports the first prospective oncologic outcomes of radiotherapy decisions as guided by 12-gene molecular assay, the DCIS score (DS).ObjectiveTo assess surgical outcomes following preoperative breast magnetic resonance imaging (MRI) in women with DCIS and estimate 5-year and 10-year ipsilateral breast event (IBE) rates in participants given DS-based postoperative radiotherapy recommendations after local excision (WLE).Design, Setting, and ParticipantsWomen with screen-detected DCIS who were eligible for WLE were enrolled to a single-arm, multicenter trial conducted at 75 institutions within the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (March 2015 to April 2016) and received a preoperative breast MRI-guided surgical treatment. Those who underwent successful WLE were advised to omit radiotherapy for low DS (<39) and receive radiotherapy for intermediate/high DS (≥39). Those achieving WLE as final treatment and successful DS assay (n = 171) were included in a prespecified analysis. Participants were followed up every 6 months for DCIS or invasive IBE, and 5-year IBE rates were analyzed from July to November 2023.InterventionDS-based postoperative radiotherapy recommendations.Main Outcomes and MeasuresFive-year IBE rates, with 95% CIs.ResultsAmong the 339 participants, the mean (SD) age was 59.1 (10.1) years. A total of 171 women (50.4%) received WLE for pure DCIS with free surgical margins and had DS data available. A total of 159 (93.0%) adhered to DS-based radiotherapy recommendations; 7 of 82 patients (8.5%) with a low DS underwent radiotherapy, and 5 of 89 patients (5.6%) with an intermediate/high DS declined radiotherapy. Over median (range) follow-up of 5 (0.5-5.0) years, 8 of 171 women experienced IBEs (4.8%; 95% CI, 2.4%-9.4%). IBE rates were similar for participants with a low DS(5.1%; 95% CI, 1.9%-12.9%) and participants with an intermediate/high DS (4.5%; 95% CI, 1.7%-11.7%). Among the 159 women who had adhered to DS-based radiotherapy recommendations, IBE rates were similar for participants with a low DS (5.5%; 95% CI, 2.1%-14.1%) and intermediate/high DS (4.8%; 95% CI, 1.8%-12.3%).Conclusions and RelevanceThe findings of this prespecified analysis of a clinical trial suggest that DS-guided radiotherapy post-WLE for DCIS shows markedly lower 5-year IBE rates (approximately 5%) for intermediate/high DS than previously reported data following WLE alone. Despite a limited sample size, these data potentially provide support for radiotherapy use in patients with intermediate/high DS, and omission when DS is low, although confirmatory studies are needed.Trial RegistrationClinicalTrials.gov Identifier: NCT02352883.
重要性乳腺导管原位癌(DCIS)由于其多变的自然病史,需要个性化治疗。该研究报告了12基因分子测定(DCIS评分)指导下放疗决定的第一个前瞻性肿瘤学结果。目的评估DCIS患者术前乳房磁共振成像(MRI)的手术效果,并评估局部切除(WLE)后接受基于ds的术后放疗建议的患者5年和10年同侧乳房事件(IBE)发生率。设计、环境和参与者:2015年3月至2016年4月,入选符合WLE条件的筛查检测到DCIS的女性参加了一项单臂、多中心试验,该试验在东部肿瘤合作组织-美国放射学成像网络学院的75家机构进行,并接受了术前乳房mri引导的手术治疗。对于低DS(<39)的患者建议省略放疗,对于中/高DS(≥39)的患者建议接受放疗。达到WLE作为最终治疗和DS试验成功的患者(n = 171)被纳入预先指定的分析。参与者每6个月随访一次DCIS或浸润性IBE,并分析2023年7月至11月5年IBE发生率。基于干预的术后放疗建议。5年IBE率,ci为95%。结果339名参与者的平均(SD)年龄为59.1(10.1)岁。171名女性(50.4%)接受了无手术切缘的单纯DCIS WLE,并获得了DS数据。共有159例(93.0%)遵循基于放射治疗的建议;82例低DS患者中有7例(8.5%)接受了放疗,89例中高DS患者中有5例(5.6%)拒绝了放疗。在5年(0.5-5.0)的中位(范围)随访中,171名女性中有8名经历了IBEs (4.8%; 95% CI, 2.4%-9.4%)。低DS患者(5.1%,95% CI, 1.9%-12.9%)和中高DS患者(4.5%,95% CI, 1.7%-11.7%)的IBE发生率相似。在159名坚持基于DS的放疗建议的女性中,低DS (5.5%; 95% CI, 2.1%-14.1%)和中/高DS (4.8%; 95% CI, 1.8%-12.3%)的IBE发生率相似。结论和相关性这项预先指定的临床试验分析的结果表明,与先前报道的单纯WLE后的数据相比,WLE后DS引导放射治疗DCIS的中/高DS的5年IBE率(约5%)显着降低。尽管样本量有限,但这些数据可能为中/高退行性椎体滑移患者使用放疗提供了支持,而当退行性椎体滑移较低时则可以忽略,尽管还需要进一步的验证性研究。临床试验注册号:NCT02352883。
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引用次数: 0
Unexpected Results of Induction Chemotherapy vs Adjuvant Chemotherapy-Reply. 诱导化疗与辅助化疗的意外结果-反应。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-16 DOI: 10.1001/jamaoncol.2025.4095
Hai-Qiang Mai
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引用次数: 0
Guidelines for Next-Generation Sequencing in Sarcoma Diagnosis and Treatment: A Consensus Review. 新一代测序在肉瘤诊断和治疗中的指南:共识综述。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-10-16 DOI: 10.1001/jamaoncol.2025.3608
César Serrano,Sebastian Bauer,Jean-Yves Blay,Paolo G Casali,Carlo M Cicala,Angelo P Dei Tos,Antonia Digklia,Hans Gelderblom,Antoine Italiano,Robin L Jones,Bernd Kasper,Anastasios Kyriazoglou,Francois Le Loarer,Javier Martín-Broto,Andrea Napolitano,Piotr Rutkowski,Silvia Stacchiotti,William Tap,David Thomas,Khin Thway,Claudia Valverde,Winette T A van der Graaf,Eva Wardelmann,Judith V M G Bovée
ImportanceSarcomas comprise a heterogeneous group of malignant neoplasms that include genomically simple (driven by recurrent genetic alterations) and genomically complex (characterized by extensive genomic rearrangements) subtypes. Regardless, sarcomas exhibit a remarkably low mutational burden. In this context, there is a growing demand for the use of next-generation sequencing (NGS)-based technologies to aid in the clinical management of patients with sarcoma. However, a broad, clinically impactful implementation faces inherent challenges associated with their rarity, heterogeneity, and limited molecular understanding.ObservationsFrom a diagnostic standpoint, there is a lack of prospective studies comparing up-front, indiscriminate use of NGS fusion panels in all new cases suggestive of sarcoma diagnosis in comparison with a use only indicated by a sarcoma-expert pathologist during the assessment. Therefore, although a significant proportion of sarcomas harbor specific molecular alterations, not all cases require NGS for a definitive diagnosis given that most sarcoma subtypes display classic histologic features. From a therapeutic perspective, current evidence does not support routine clinical use of NGS in all patients with sarcoma due to the small number of actionable alterations and the limited evidence for clinical benefit achieved with NGS-matched treatments. Although certain entities and molecular backgrounds demonstrate potential advantages, the consensus group emphasizes that indication of targeted agents for treatment is largely based on the specific subtype, and therefore, an accurate diagnosis is indispensable.Conclusions and RelevanceEvidence supporting the routine, nonselective use of NGS in patients with sarcoma is currently limited. Given the complexity, the decision to perform an NGS panel, as well as the interpretation and use of its results for diagnostic or therapeutic purposes, should take place only in sarcoma-expert institutions, including a multidisciplinary review. The results of multigene panels performed in nonexpert sarcoma centers cannot replace the pathology review or the recommendation of NGS-guided therapies without prior evaluation by sarcoma experts.
肉瘤由异质性的恶性肿瘤组成,包括基因组简单亚型(由复发性遗传改变驱动)和基因组复杂亚型(以广泛的基因组重排为特征)。无论如何,肉瘤表现出非常低的突变负担。在这种情况下,使用基于下一代测序(NGS)的技术来帮助肉瘤患者的临床管理的需求日益增长。然而,广泛的、具有临床影响的实施面临着与它们的稀有性、异质性和有限的分子理解相关的固有挑战。从诊断的角度来看,缺乏前瞻性研究来比较在所有提示肉瘤诊断的新病例中预先不加选择地使用NGS融合板与仅在评估期间由肉瘤专家病理学家指示使用的NGS融合板。因此,尽管很大一部分肉瘤具有特定的分子改变,但鉴于大多数肉瘤亚型表现出典型的组织学特征,并非所有病例都需要NGS进行明确诊断。从治疗角度来看,目前的证据并不支持在所有肉瘤患者中常规使用NGS,因为可操作的改变很少,而且NGS匹配治疗获得的临床获益证据有限。虽然某些实体和分子背景显示出潜在的优势,但共识组强调靶向药物的适应症主要基于特定的亚型,因此,准确的诊断是必不可少的。结论和相关性目前支持肉瘤患者常规、非选择性使用NGS的证据有限。考虑到复杂性,只有肉瘤专家机构才能决定是否进行NGS小组,以及对其结果的解释和用于诊断或治疗目的,包括多学科审查。在没有肉瘤专家事先评估的情况下,在非专家肉瘤中心进行的多基因小组检查的结果不能取代病理检查或ngs指导疗法的推荐。
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引用次数: 0
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JAMA Oncology
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