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Lymph Node Dissection Guideline Adherence and Survival in Patients With T1N0M0 Lung Adenocarcinoma 淋巴结清扫指南在T1N0M0肺腺癌患者中的依从性和生存率
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-15 DOI: 10.1001/jamaoncol.2025.5924
Renda Li, Pan Wang, Hao Zhang, Qingpeng Zeng, Chenran Wang, Ni Li, Wenjing Yang, Fengwei Tan, Jie He
Importance Lymph node dissection for early-stage lung adenocarcinoma is controversial. Histologic pattern subtyping reveals heterogeneity of lung adenocarcinoma, yet its association with lymph node involvement and dissection is understudied. Objective To assess the association between guideline-adherent lymph node dissection, histologic pattern subtyping, and overall survival in patients with clinical T1N0M0 lung adenocarcinoma. Design, Setting, and Participants This multicenter cohort study used data from the National Cancer Center LungReal database, a multicenter, electronic health records-based database for patients undergoing surgery for lung cancer, from January 2014 to December 2021, with the last follow-up in December 2022. Patients were categorized based on histologic pattern of adenocarcinoma into 2 groups: lepidic without high-grade pattern, and high-grade or no lepidic pattern. The data analysis was performed from April to November 2025. Exposure Lymph node dissection adherence or nonadherence with the 3 + 1 standard (3 N2 plus 1 N1 station) and the 6-station standard (the subcarinal plus 2 other N2 stations and 3 N1 stations). Main Outcome and Measure Overall survival. Results Of 35 265 patients screened, 27 191 participants (mean [SD] age, 58.3 [11.7] years; 16 280 female [59.9%] and 10 911 male [40.1%] individuals) from 19 centers were included; among them, 15 593 (57.3%) received lymph node dissection adherent with the 3 + 1 standard and 4023 (14.8%) with the 6-station standard. Among the group of 13 369 patients (49.2%) with adenocarcinoma of lepidic without high-grade pattern, no association was observed between survival and adherence with the 3 + 1 standard (hazard ratio [HR], 0.81; 95% CI, 0.57-1.15) or the 6-station standard (HR, 0.54; 95% CI, 0.26-1.13). Whereas, among the group of 13 822 patients (50.8%) with adenocarcinoma of high-grade or no lepidic pattern, adherence with the 3 + 1 standard (HR, 0.81; 95% CI, 0.69-0.95; absolute risk difference at 3-year, 1.2%; 95% CI, 0.2%-2.2%; E-value, 1.78) or the 6-station standard (HR, 0.61; 95% CI, 0.45-0.83; absolute risk difference at 3 years, 1.0%; 95% CI, 0.1%-1.9%; E-value, 2.67) was associated with a significant but small absolute survival benefit. Conclusion and Relevance In this cohort study, guideline-adherent nodal dissection was associated with small absolute survival benefit for patients with adenocarcinoma of high-grade or no lepidic pattern, but not for those with lepidic without high-grade pattern. These observational findings warrant prospective validation and should not be interpreted as causal.
早期肺腺癌的淋巴结清扫是有争议的。组织学亚型显示肺腺癌的异质性,但其与淋巴结累及和清扫的关系尚不清楚。目的探讨临床T1N0M0肺腺癌患者依指南淋巴结清扫、组织学亚型与总生存率的关系。这项多中心队列研究使用了2014年1月至2021年12月期间美国国家癌症中心LungReal数据库(一个多中心、基于电子健康记录的肺癌手术患者数据库)的数据,最后一次随访是在2022年12月。根据腺癌的组织学类型将患者分为两组:无高级别模式的鳞状癌和高级别或无鳞状癌。数据分析时间为2025年4月至11月。淋巴结清扫符合或不符合3 + 1标准(3个N2加1个N1站)和6站标准(隆突下加2个其他N2站和3个N1站)。主要结局和测量总生存期。结果在筛选的35 265例患者中,包括来自19个中心的27 191例参与者(平均[SD]年龄58.3[11.7]岁,女性16 280例[59.9%],男性10 911例[40.1%]);其中3 + 1标准行淋巴结清扫15 593例(57.3%),6站标准行淋巴结清扫4023例(14.8%)。在13 369例(49.2%)无高级别肾腺癌患者中,生存率与3 + 1标准(风险比[HR]为0.81;95% CI为0.57-1.15)或6站标准(风险比[HR]为0.54;95% CI为0.26-1.13)之间无相关性。然而,在13 822例(50.8%)高级别或无肾型腺癌患者中,坚持3 + 1标准(HR, 0.81; 95% CI, 0.69-0.95; 3年绝对风险差为1.2%;95% CI, 0.2%-2.2%; e值,1.78)或6站标准(HR, 0.61; 95% CI, 0.45-0.83; 3年绝对风险差为1.0%;95% CI, 0.1%-1.9%; e值,2.67)与显著但较小的绝对生存获益相关。结论和相关性在这项队列研究中,对于高级别或无leidad模式的腺癌患者,遵循指南的淋巴结清扫与小的绝对生存获益相关,而对于无高级别leidad模式的腺癌患者则无关。这些观察结果保证了前瞻性验证,不应被解释为因果关系。
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引用次数: 0
Sodium-Glucose Cotransporter 2 Inhibitors for Patients With Prostate Cancer Undergoing Hormone Therapy 钠-葡萄糖共转运蛋白2抑制剂在前列腺癌激素治疗中的应用
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-08 DOI: 10.1001/jamaoncol.2025.5869
Ruofan Shi, Yongle Zhan, Ruochen Ma, Salida Ali, Chi Yao, Tsun Tsun Stacia Chun, Ada Tsui-Lin Ng, Matthew Kin-Liang Chiu, Bryan Cho Wing Li, Rong Na
Importance While preliminary evidence suggests that sodium-glucose cotransporter 2 (SGLT2) inhibitors for diabetes may have antitumorigenic effects, their potential benefits in prostate cancer remain unexplored. Understanding their association with outcomes among patients undergoing hormone therapy could inform future adjunct treatment strategies. Objective To evaluate whether the use of SGLT2 inhibitors is associated with clinical outcomes in patients with prostate cancer receiving hormone therapy. Design, Setting, and Participants This population-based, sequential target trial emulation of monthly cohorts used territory-wide electronic health records (January 1, 1993, to April 30, 2025) from the Hong Kong Hospital Authority, covering a population of approximately 7.5 million. Adult men diagnosed with prostate cancer who initiated androgen deprivation therapy (ADT) were included. Follow-up extended through April 2025, and data were analyzed from June to October 2025. Exposures Use of SGLT2 inhibitors (primarily dapagliflozin and empagliflozin) initiated during hormone therapy and maintained for at least 1 month. Comparator groups included nonusers of SGLT2 inhibitors. Main Outcomes and Measures The primary outcome was time to ADT failure. Secondary outcomes include time to next-generation hormonal agent failure, disease-specific survival, and overall survival. Both intention-to-treat and per-protocol analyses were conducted using complementary log-log model regression to provide the hazard ratio (HR) estimate. Results Among 14 223 eligible patients (median [IQR] age at enrollment, 74 [68-80] years) with a median follow-up of 66 months (95% CI, 65-67 months), intention-to-treat SGLT2 inhibitor use was associated with reduced risk of ADT failure (HR, 0.63; 95% CI, 0.41-0.95; P = .03) and next-generation hormonal agent failure (HR, 0.44; 95% CI, 0.20-0.97; P = .04). Sensitivity analyses confirmed robustness of these findings across different comparator subgroups. Metformin monotherapy was not associated with disease progression but was associated with improved overall survival (HR, 0.59; 95% CI, 0.42-0.83; P = .002). No statistically significant outcome differences were observed between dapagliflozin and empagliflozin. Conclusions and Relevance In this cohort study with a target trial emulation design, SGLT2 inhibitor use was associated with delayed hormone therapy failure in patients with prostate cancer, suggesting a potential oncologic benefit beyond glucose lowering. These findings support the potential of SGLT2 inhibitors in treatment for prostate cancer.
虽然初步证据表明,钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂治疗糖尿病可能具有抗肿瘤作用,但其对前列腺癌的潜在益处尚不清楚。了解它们与接受激素治疗的患者预后的关系可以为未来的辅助治疗策略提供信息。目的评价SGLT2抑制剂的使用是否与接受激素治疗的前列腺癌患者的临床结果相关。设计、设置和参与者这项以人群为基础的顺序目标试验模拟每月队列,使用香港医院管理局的全地区电子健康记录(1993年1月1日至2025年4月30日),涵盖约750万人口。被诊断为前列腺癌并开始雄激素剥夺治疗(ADT)的成年男性被纳入研究对象。随访至2025年4月,分析2025年6月至10月的数据。在激素治疗期间开始使用SGLT2抑制剂(主要是达格列净和恩格列净)并维持至少1个月。比较组包括未使用SGLT2抑制剂的患者。主要观察指标为ADT失效时间。次要结局包括到下一代激素药物失效的时间、疾病特异性生存期和总生存期。意向治疗和方案分析均使用互补对数-对数模型回归进行,以提供风险比(HR)估计。结果在14223例符合条件的患者中(入组时中位[IQR]年龄为74[68-80]岁),中位随访66个月(95% CI, 65-67个月),有意治疗SGLT2抑制剂的使用与ADT失败风险降低(HR, 0.63; 95% CI, 0.41-0.95; P = 0.03)和下一代激素药物失败风险降低(HR, 0.44; 95% CI, 0.20-0.97; P = 0.04)相关。敏感性分析证实了这些发现在不同比较物亚组中的稳健性。二甲双胍单药治疗与疾病进展无关,但与改善的总生存率相关(HR, 0.59; 95% CI, 0.42-0.83; P = 0.002)。在达格列净和恩格列净之间没有统计学上的显著差异。结论和相关性在这项目标试验模拟设计的队列研究中,SGLT2抑制剂的使用与前列腺癌患者延迟激素治疗失败相关,这表明除了降糖外,SGLT2抑制剂的潜在肿瘤益处。这些发现支持SGLT2抑制剂治疗前列腺癌的潜力。
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引用次数: 0
Projected Cancer Screening and Outcomes Under the 2025 Federal Medicaid Eligibility Restrictions 2025年联邦医疗补助资格限制下的预计癌症筛查和结果
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-08 DOI: 10.1001/jamaoncol.2025.5774
Sarah P. Shubeck, Adrian Diaz
This decision analytical model evaluates projected changes in cancer screening and outcomes following changes to federal Medicaid funding and eligibility restrictions enacted with the 2025 Budget Reconciliation Bill.
该决策分析模型评估了随着2025年预算和解法案颁布的联邦医疗补助资金和资格限制的变化,癌症筛查和结果的预计变化。
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引用次数: 0
Clonal Hematopoiesis and Cardiovascular Disease Risk After Cancer Therapy in Patients With Solid Tumors 实体瘤患者肿瘤治疗后克隆造血与心血管疾病风险
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-08 DOI: 10.1001/jamaoncol.2025.5785
Derek Shyr, Yash Pershad, Kun Zhao, Ashwin Kishtagari, Robert W. Corty, Eric Shinohara, Ben Ho Park, J. Brett Heimlich, Leo Luo, Alexander G. Bick
Importance Cancer survivors have increased cardiovascular disease (CVD) risk partly due to the toxic effects of cancer therapy. Clonal hematopoiesis of indeterminate potential (CHIP), an age-associated blood disorder caused by somatic variants in blood stem cells, is more prevalent among individuals receiving cancer therapy and increases CVD risk independent of traditional risk factors. It is unknown whether CHIP amplifies therapy-related cardiovascular toxic effects in patients with cancer. Objective To assess the association between CHIP and CVD risk, accounting for competing risks, among patients with primary solid tumors who received chemotherapy, radiotherapy, or immunotherapy. Design, Setting, and Participants A cohort study was conducted using BioVU, Vanderbilt University Medical Center’s biorepository linking electronic health records to whole-genome sequencing data from 250 038 participants from 2006 to 2025. In this cohort, participants had a primary solid tumor diagnosis, received chemotherapy, radiotherapy, and/or immunotherapy, and did not have hematologic malignant disease before treatment. Data were analyzed from June 2025 to November 2025. Exposures CHIP variants detected via whole-genome sequencing, chemotherapy, radiotherapy, and immunotherapy. Main Outcomes and Measures Time to first cardiovascular event, defined as heart failure, ischemic CVD, or arrhythmia following cancer treatment. Results Among 8004 eligible participants (median [IQR] age, 61.9 [52.2-69.9] years; 4385 female individuals [54.8%]) with a primary solid tumor diagnosis, 7438 had no heart failure, 7392 no ischemic CVD, and 6002 no arrhythmia before cancer therapy. Overall, 549 (6.9%) had CHIP. In the propensity score–matched cohort, participants with CHIP had a significantly higher 10-year cumulative incidence of heart failure (20.3%; 95% CI, 16.0%-24.4% vs 14.5%; 95% CI, 13.5%-15.6%; P = .001) and ischemic CVD (25.3%; 95% CI, 20.5%-30.0% vs 18.5%; 95% CI, 17.3%-20.0%; P &amp;lt; .001) compared with those without CHIP. In adjusted Fine-Gray models, CHIP was associated with increased risk of heart failure (subdistribution hazard ratio [sHR], 1.26; 95% CI, 1.02-1.56; P = .03). In an exploratory 24-month landmark analysis, there was a statistically significant interaction between CHIP and intensive chemotherapy (≥7 cycles) on heart failure risk (sHR, 1.02; 95% CI, 1.00-1.04; P = .03). Conclusions and Relevance In this cohort study, CHIP was associated with increased CVD risk in patients with solid tumors receiving cancer therapy. This finding suggests incorporating CHIP status may improve cardio-oncology treatment of cancer survivors.
癌症幸存者患心血管疾病(CVD)的风险增加,部分原因是癌症治疗的毒性作用。克隆性不确定潜能造血(CHIP)是一种与年龄相关的血液疾病,由血液干细胞的体细胞变异引起,在接受癌症治疗的个体中更为普遍,并且增加了与传统危险因素无关的心血管疾病风险。目前尚不清楚CHIP是否会放大癌症患者治疗相关的心血管毒性作用。目的评估在接受化疗、放疗或免疫治疗的原发性实体肿瘤患者中CHIP与CVD风险之间的关系,并考虑竞争风险。设计、设置和参与者使用BioVU(范德比尔特大学医学中心的生物库)进行了一项队列研究,将2006年至2025年25038名参与者的电子健康记录与全基因组测序数据联系起来。在这个队列中,参与者被诊断为原发性实体瘤,接受了化疗、放疗和/或免疫治疗,并且在治疗前没有血液恶性疾病。数据分析时间为2025年6月至2025年11月。暴露CHIP变异检测通过全基因组测序,化疗,放疗和免疫治疗。主要结局和测量:发生第一次心血管事件的时间,定义为癌症治疗后的心力衰竭、缺血性心血管疾病或心律失常。结果在8004名原发性实体瘤患者(中位[IQR]年龄为61.9[52.2-69.9]岁;4385名女性[54.8%])中,7438名患者在癌症治疗前无心力衰竭,7392名患者无缺血性心血管疾病,6002名患者无心律失常。总体而言,549例(6.9%)患有CHIP。在倾向评分匹配的队列中,CHIP患者的10年累积心力衰竭(20.3%;95% CI, 16.0%-24.4% vs 14.5%; 95% CI, 13.5%-15.6%; P = 0.001)和缺血性心血管疾病(25.3%;95% CI, 20.5%-30.0% vs 18.5%; 95% CI, 17.3%-20.0%; P & lt;001)与没有CHIP的患者相比。在调整后的Fine-Gray模型中,CHIP与心力衰竭风险增加相关(亚分布风险比[sHR], 1.26; 95% CI, 1.02-1.56; P = .03)。在一项为期24个月的探索性里程碑分析中,CHIP与强化化疗(≥7个周期)对心力衰竭风险的相互作用具有统计学意义(sHR, 1.02; 95% CI, 1.00-1.04; P = 0.03)。结论和相关性在这项队列研究中,CHIP与接受癌症治疗的实体瘤患者心血管疾病风险增加相关。这一发现表明,纳入CHIP状态可能会改善癌症幸存者的心脏肿瘤治疗。
{"title":"Clonal Hematopoiesis and Cardiovascular Disease Risk After Cancer Therapy in Patients With Solid Tumors","authors":"Derek Shyr, Yash Pershad, Kun Zhao, Ashwin Kishtagari, Robert W. Corty, Eric Shinohara, Ben Ho Park, J. Brett Heimlich, Leo Luo, Alexander G. Bick","doi":"10.1001/jamaoncol.2025.5785","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.5785","url":null,"abstract":"Importance Cancer survivors have increased cardiovascular disease (CVD) risk partly due to the toxic effects of cancer therapy. Clonal hematopoiesis of indeterminate potential (CHIP), an age-associated blood disorder caused by somatic variants in blood stem cells, is more prevalent among individuals receiving cancer therapy and increases CVD risk independent of traditional risk factors. It is unknown whether CHIP amplifies therapy-related cardiovascular toxic effects in patients with cancer. Objective To assess the association between CHIP and CVD risk, accounting for competing risks, among patients with primary solid tumors who received chemotherapy, radiotherapy, or immunotherapy. Design, Setting, and Participants A cohort study was conducted using BioVU, Vanderbilt University Medical Center’s biorepository linking electronic health records to whole-genome sequencing data from 250 038 participants from 2006 to 2025. In this cohort, participants had a primary solid tumor diagnosis, received chemotherapy, radiotherapy, and/or immunotherapy, and did not have hematologic malignant disease before treatment. Data were analyzed from June 2025 to November 2025. Exposures CHIP variants detected via whole-genome sequencing, chemotherapy, radiotherapy, and immunotherapy. Main Outcomes and Measures Time to first cardiovascular event, defined as heart failure, ischemic CVD, or arrhythmia following cancer treatment. Results Among 8004 eligible participants (median [IQR] age, 61.9 [52.2-69.9] years; 4385 female individuals [54.8%]) with a primary solid tumor diagnosis, 7438 had no heart failure, 7392 no ischemic CVD, and 6002 no arrhythmia before cancer therapy. Overall, 549 (6.9%) had CHIP. In the propensity score–matched cohort, participants with CHIP had a significantly higher 10-year cumulative incidence of heart failure (20.3%; 95% CI, 16.0%-24.4% vs 14.5%; 95% CI, 13.5%-15.6%; <jats:italic toggle=\"yes\">P</jats:italic> = .001) and ischemic CVD (25.3%; 95% CI, 20.5%-30.0% vs 18.5%; 95% CI, 17.3%-20.0%; <jats:italic toggle=\"yes\">P</jats:italic> &amp;amp;lt; .001) compared with those without CHIP. In adjusted Fine-Gray models, CHIP was associated with increased risk of heart failure (subdistribution hazard ratio [sHR], 1.26; 95% CI, 1.02-1.56; <jats:italic toggle=\"yes\">P</jats:italic> = .03). In an exploratory 24-month landmark analysis, there was a statistically significant interaction between CHIP and intensive chemotherapy (≥7 cycles) on heart failure risk (sHR, 1.02; 95% CI, 1.00-1.04; <jats:italic toggle=\"yes\">P</jats:italic> = .03). Conclusions and Relevance In this cohort study, CHIP was associated with increased CVD risk in patients with solid tumors receiving cancer therapy. This finding suggests incorporating CHIP status may improve cardio-oncology treatment of cancer survivors.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"2 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145919904","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
Baseline Fatigue and Severe Toxic Effects in Patients With Cancer Receiving Systemic Therapy. 接受全身治疗的癌症患者的基线疲劳和严重毒性作用。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-12-26 DOI: 10.1001/jamaoncol.2025.5549
Joseph M Unger,Michael J Fisch,Salene M W Jones,N Lynn Henry,Dawn L Hershman
ImportanceFatigue is a common symptom reported by patients with cancer, yet its role as a predictor of treatment-related toxic effects has not been well characterized. Understanding whether fatigue measured at treatment initiation may be associated with subsequent toxic effects could help guide individualized treatment planning and symptom monitoring.ObjectiveTo evaluate the association between baseline patient-reported fatigue and the risk of adverse events (AEs) in cancer treatment trials.Design, Setting, and ParticipantsThis cohort study and pooled analysis assessed baseline fatigue data from 17 SWOG phase 2 and 3 trials conducted from 1990 to 2022. Patients were enrolled across multiple cancer types and treatment settings. Data analysis was performed from March 1, 2023, to October 17, 2025.ExposuresBaseline fatigue, classified on a 5-point Likert scale, analyzed as binary thresholds (eg, <some vs ≥some fatigue) and across fatigue severity levels.Main Outcomes and MeasuresAdverse events were classified using the Common Terminology Criteria for Adverse Events (CTCAE), with multiple versions mapped to version 4. Symptomatic AEs followed the Patient-Reported Outcomes-CTCAE framework; laboratory-based or measurable toxic effects were considered objective (hematologic vs nonhematologic). Primary outcomes were grade 3 or higher (severe), grade 4 or higher (life-threatening), and grade 5 (fatal) AEs. Odds ratios (ORs) were estimated using generalized estimating equations. To account for confounding, the analysis was clustered by trial and adjusted for age, sex, race, and obesity.ResultsAmong 7086 patients (mean [SD] age, 62.1 [15.2] years; 2107 females [29.7%] and 4979 males [70.3%]) with prostate, lung, colorectal, lymphoma, breast, melanoma, ovarian, or pancreatic cancer, 103 738 AEs were reported. At baseline, 2771 participants (39.1%) reported some or more fatigue. Proportions with maximum AEs rated grade 3 or higher, grade 4 or higher, and grade 5 were 3128 participants (44.1%), 1001 (14.1%), and 62 (0.9%), respectively. Compared with those reporting no or minimal fatigue, patients with some fatigue or more had higher risks of severe or worse toxic effects (odds ratio [OR], 2.09; 95% CI, 1.58-2.78; P < .001), life-threatening or fatal toxic effects (OR, 1.96; 95% CI, 1.36-2.82; P < .001), and fatal toxic effects (OR, 2.35; 95% CI, 1.07-5.19; P = .03). A dose-response pattern was evident: patients reporting quite a lot or very much fatigue had an approximately 5-fold higher risk of fatal toxic effects (OR, 4.99; 95% CI, 1.84-13.51; P = .002). Findings were consistent across symptomatic, hematologic, and nonhematologic AE categories.Conclusions and RelevanceThis cohort study found that baseline patient-reported fatigue was associated with an increased risk of cancer treatment-related toxic effects. Fatigue assessments at treatment initiation may serve as an early clinical marker of risk for toxic effects and may help inform personalized treatment
疲劳是癌症患者报告的常见症状,但其作为治疗相关毒性效应预测因子的作用尚未得到很好的表征。了解在治疗开始时测量的疲劳是否可能与随后的毒性作用有关,有助于指导个体化治疗计划和症状监测。目的评价癌症治疗试验中基线患者报告的疲劳与不良事件(ae)风险之间的关系。设计、环境和参与者本队列研究和汇总分析评估了1990年至2022年进行的17项SWOG二期和三期试验的基线疲劳数据。患者被纳入了多种癌症类型和治疗方案。数据分析时间为2023年3月1日至2025年10月17日。基线疲劳,按5点李克特量表分类,分析为二值阈值(例如,<一些疲劳vs≥一些疲劳)和疲劳严重程度。使用不良事件通用术语标准(CTCAE)对不良事件进行分类,并将多个版本映射到版本4。症状性ae遵循患者报告结果- ctcae框架;基于实验室或可测量的毒性作用被认为是客观的(血液学与非血液学)。主要结局为3级或以上(严重)、4级或以上(危及生命)和5级(致命)ae。比值比(ORs)采用广义估计方程估计。为了考虑混杂因素,分析通过试验聚类,并根据年龄、性别、种族和肥胖进行调整。结果7086例前列腺癌、肺癌、结直肠癌、淋巴瘤、乳腺癌、黑色素瘤、卵巢癌、胰腺癌患者(平均[SD]年龄62.1[15.2]岁,女性2107例[29.7%],男性4979例[70.3%])共报告ae 103 738例。在基线时,2771名参与者(39.1%)报告了一些或更多的疲劳。最大ae评级为3级或更高、4级或更高和5级的比例分别为3128(44.1%)、1001(14.1%)和62(0.9%)。与报告无疲劳或轻微疲劳的患者相比,有一些或更多疲劳的患者有更高的严重或更严重毒性反应的风险(优势比[or], 2.09; 95% CI, 1.58-2.78; P <。0.001),危及生命或致命的毒性作用(or, 1.96; 95% CI, 1.36-2.82; P <。和致死性毒性效应(OR, 2.35; 95% CI, 1.07-5.19; P = .03)。剂量-反应模式很明显:报告相当多或非常疲劳的患者发生致命毒性作用的风险大约高出5倍(or, 4.99; 95% CI, 1.84-13.51; P = 0.002)。结果在症状性、血液学和非血液学AE类别中一致。结论和相关性本队列研究发现,基线患者报告的疲劳与癌症治疗相关毒性作用的风险增加有关。治疗开始时的疲劳评估可以作为毒性作用风险的早期临床标志,并有助于告知个性化治疗策略和症状监测。
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引用次数: 0
Oncology Drug Revenue and Price Negotiation. 肿瘤药物收入和价格谈判。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-12-26 DOI: 10.1001/jamaoncol.2025.5385
Aaron P Mitchell,Rachel E Sachs,Stacie B Dusetzina
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引用次数: 0
Enhancement of Patient-Centered Lung Cancer Screening: The MyLungHealth Randomized Clinical Trial. 增强以患者为中心的肺癌筛查:MyLungHealth随机临床试验
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-12-26 DOI: 10.1001/jamaoncol.2025.5672
Polina V Kukhareva,Haojia Li,Christian Balbin,Elizabeth R Stevens,Devin M Mann,Jorie M Butler,Tanner J Caverly,Guilherme Del Fiol,Kimberly A Kaphingst,Chelsey R Schlechter,Victoria L Tiase,Angela Fagerlin,Yue Zhang,Rachel Hess,Michael C Flynn,Chakravarthy Reddy,Douglas Martin,Phillip B Warner,Claude Nanjo,Joshua Choi,Quyen Ngo-Metzger,Kensaku Kawamoto
ImportanceLung cancer screening (LCS) with low-dose computed tomography (CT) remains underused in the US, partly because of incomplete smoking history documentation in electronic health records (EHRs) and limited time for shared decision-making in primary care.ObjectiveTo determine whether a patient-facing, EHR-integrated tool combined with clinician-facing clinical decision support improves the identification of LCS-eligible patients and the ordering of low-dose CT compared with clinician-facing tools alone.Design, Setting, and ParticipantsThis pragmatic, unstratified, randomized clinical trial with parallel groups was conducted from March 29, 2024, to March 28, 2025, at primary care clinics at University of Utah Health and New York University Langone Health. Adults aged 50 to 79 years with a documented smoking history, an active patient portal account, and a primary care visit in the preceding year were included. Study 1 enrolled patients with uncertain LCS eligibility (10 to 19 pack-years, unknown pack-years, or missing quit date); study 2 enrolled patients with documented eligibility (20 or more pack-years and currently smoking or quit smoking within 15 years).InterventionsThe control included the clinician-facing Decision Precision+ tool (preventive care reminders and a shared decision-making tool). The intervention included the Decision Precision+ tool as well as the MyLungHealth tool, which collected detailed smoking history (study 1) and delivered personalized education and risk/benefit information (studies 1 and 2) via the patient portal in English and Spanish.Main Outcomes and MeasuresThe primary outcomes were the proportion of patients newly identified as eligible for LCS (study 1) and low-dose CT ordering rates (study 2) over 12 months. Analyses used intention-to-treat mixed-effects logistic regression.ResultsThere were 31 303 randomized participants, including 26 729 in study 1 (13 144 [49.2%] female; 13 580 [50.8%] male; median [IQR] age, 62 [55-69] years) and 4574 in study 2 (2230 [48.8%] female; 2344 [51.2%] male; median [IQR] age, 63 [56-69] years). In study 1, the MyLungHealth tool increased new LCS eligibility identification (635 of 13 412 [4.7%] vs 308 of 13 317 [2.3%]; adjusted odds ratio, 2.19; 95% CI, 1.99-2.42; P < .001). In study 2, low-dose CT ordering was higher in the intervention arm (474 of 2312 [20.5%] vs 434 of 2262 [19.2%]; adjusted odds ratio, 1.16; 95% CI, 1.04-1.30; P = .008).Conclusions and RelevanceIn this randomized clinical trial, integrating a patient-centered tool into primary care EHR workflows increased the identification of patients eligible for LCS and the ordering of low-dose CTs. The relative increases in these primary outcomes were substantial, but absolute increases were more modest. Research on more intensive interventions is warranted to evaluate their ability to further improve LCS screening.Trial RegistrationClinicalTrials.gov Identifier: NCT06338592.
在美国,低剂量计算机断层扫描(CT)肺癌筛查(LCS)仍未得到充分利用,部分原因是电子健康记录(EHRs)中吸烟史记录不完整,以及初级保健共同决策的时间有限。目的探讨与单独面向临床的工具相比,面向患者的ehr集成工具与面向临床的临床决策支持相结合是否能提高lcs合格患者的识别和低剂量CT的排序。设计、环境和参与者这项实用的、非分层的、平行组随机临床试验于2024年3月29日至2025年3月28日在犹他大学健康中心和纽约大学朗格尼健康中心的初级保健诊所进行。年龄在50岁至79岁之间,有吸烟史、活跃的患者门户账户和前一年的初级保健就诊记录的成年人被纳入研究对象。研究1纳入了不确定LCS资格的患者(10 - 19包年、未知包年或缺失戒烟日期);研究2纳入了有记录的合格患者(20包年或以上,目前吸烟或在15年内戒烟)。干预措施对照组包括面向临床医生的决策精度+工具(预防性护理提醒和共享决策工具)。干预包括决策精度+工具以及MyLungHealth工具,该工具收集了详细的吸烟史(研究1),并通过患者门户网站以英语和西班牙语提供个性化教育和风险/益处信息(研究1和2)。主要结果和测量主要结果是12个月内新确定的符合LCS(研究1)和低剂量CT订购率(研究2)的患者比例。分析使用意向-治疗混合效应逻辑回归。结果31 303名随机受试者,其中研究1 26 729名(女性13 144名[49.2%];男性13 580名[50.8%];研究2中位[IQR]年龄62[55-69]岁)和4574名(女性2230名[48.8%];男性2344名[51.2%];中位[IQR]年龄63[56-69]岁)。在研究1中,MyLungHealth工具增加了新的LCS资格鉴定(13名 412中的635名[4.7%]vs 13名 317中的308名[2.3%];调整后的优势比为2.19;95% CI, 1.99-2.42; P < .001)。在研究2中,干预组低剂量CT排序较高(2312例中有474例[20.5%],2262例中有434例[19.2%];校正优势比为1.16;95% CI为1.04-1.30;P = 0.008)。结论和相关性在这项随机临床试验中,将以患者为中心的工具整合到初级保健电子病历工作流程中,增加了对符合LCS条件的患者的识别和低剂量ct的排序。这些主要结果的相对增加是可观的,但绝对增加则较为温和。有必要研究更密集的干预措施,以评估其进一步改善LCS筛查的能力。临床试验注册号:NCT06338592。
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引用次数: 0
Concerns in the Propensity Score-Matched Analysis-Reply. 倾向得分匹配分析中的问题。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-12-26 DOI: 10.1001/jamaoncol.2025.5561
Yongmei Huang,Yukio Suzuki,Jason D Wright
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引用次数: 0
Concerns in the Propensity Score-Matched Analysis. 倾向得分匹配分析中的关注点。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-12-26 DOI: 10.1001/jamaoncol.2025.5558
Yoshihide Inayama,Toshiki Fukasawa,Koji Yamanoi
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引用次数: 0
Immune Checkpoint Inhibitor-Induced Diabetes Across National Cancer Institute Trials That Included PD-1 or PD-L1 Agents. 免疫检查点抑制剂诱导糖尿病在国家癌症研究所的试验,包括PD-1或PD-L1药物。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2025-12-26 DOI: 10.1001/jamaoncol.2025.5594
Zoe E Quandt,Shanda Finnigan,Vanessa Hill,Joe E Dib,Jason Burian,Sapir Tessler,Darah Davidson,Abdul Rafeh Naqash,Mark S Anderson,Megan Othus,Elad Sharon
ImportanceImmune-related adverse events (IRAEs) limit the use of cancer immunotherapy. Understanding the risk of severe IRAEs may help improve the use of cancer immunotherapy.ObjectiveTo review and assess hyperglycemic events across thousands of patients to characterize immune checkpoint inhibitor (ICI)-induced diabetes (ICI-D) using a large-scale trial conglomerate.Design, Setting, and ParticipantsAdverse event (AE) reports related to diabetes, hyperglycemia, and acidosis were retrieved from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) database. Trial data from June 2015 to December 2022 were analyzed. Clinical information was manually retrieved. Overall counts of patients on each trial were retrieved from central NCI data. NCI CTEP trials are hosted in both academic and community medical centers. This analysis includes patients across 158 trials who were treated with varying regimens that included programmed cell death 1 protein (PD-1) or programmed cell death 1 ligand 1 (PD-L1) inhibitors through an NCI CTEP trial for their cancer from June 2015 to December 2022. Data clarifications were requested and then data were analyzed from January 2023 to June 1, 2025.Main Outcomes and MeasuresClinical characteristics differentiating ICI-D from other causes of hyperglycemia were enumerated. Cumulative incidence rates of ICI-D were calculated using trial-level data. Logistic regression was used to calculate the odds of developing ICI-D.ResultsIn 13 966 patients across 158 trials, the overall cumulative incidence of ICI-D was low (0.52 per 100 treated patients), but incidence varied by treatment type and was lower if patients were exposed to concurrent chemotherapy (0.65% without chemotherapy vs 0.26% with chemotherapy; odds ratio [OR], 0.38; 95% CI, 0.21-0.71; P = .002) and higher if patients were exposed to combined immunotherapy (0.94% with combination immunotherapy vs 0.37% with PD-1/PD-L1 inhibitor monotherapy; OR, 2.68; 95% CI, 1.69-4.24). Despite these low rates, the health care burden of ICI-D was high, with 90% requiring hospitalization at diagnosis and 43% requiring intensive care. The degree of hyperglycemia can be used to differentiate different etiologies of hyperglycemia, with higher glucose levels being more likely to be due to ICI-D.Conclusions and RelevanceResults of this study suggest that ICI-D is a rare but morbid condition that varies based on the combination of ICIs with other agents.
免疫相关不良事件(IRAEs)限制了癌症免疫治疗的使用。了解严重irae的风险可能有助于改善癌症免疫治疗的使用。目的回顾和评估数千例患者的高血糖事件,以确定免疫检查点抑制剂(ICI)诱导的糖尿病(ICI- d)的特征。设计、环境和参与者从美国国家癌症研究所(NCI)癌症治疗评估计划(CTEP)数据库中检索与糖尿病、高血糖和酸中毒相关的不良事件(AE)报告。对2015年6月至2022年12月的试验数据进行分析。手动检索临床信息。每个试验的患者总数从NCI中心数据中检索。NCI CTEP试验在学术和社区医疗中心进行。该分析包括158项试验的患者,这些患者在2015年6月至2022年12月期间通过NCI CTEP试验接受了不同方案的治疗,包括程序性细胞死亡1蛋白(PD-1)或程序性细胞死亡1配体1 (PD-L1)抑制剂。要求对数据进行澄清,然后对2023年1月至2025年6月1日的数据进行分析。主要结果和测量方法列举了区分ICI-D与其他高血糖原因的临床特征。使用试验水平数据计算ci - d的累积发病率。采用Logistic回归计算发生ci - d的几率。结果在158项试验中的13 966例患者中,CI- d的总体累积发病率较低(每100名接受治疗的患者中有0.52例),但发病率因治疗类型而异,如果患者同时接受化疗,则发病率较低(未接受化疗的0.65% vs接受化疗的0.26%;比值比[OR]为0.38;95% CI为0.21-0.71;P = 0.38。002),如果患者接受联合免疫治疗,则更高(联合免疫治疗为0.94%,PD-1/PD-L1抑制剂单药治疗为0.37%;OR为2.68;95% CI为1.69-4.24)。尽管发病率很低,但ICI-D的医疗负担很高,90%的患者在诊断时需要住院治疗,43%的患者需要重症监护。高血糖程度可用于区分高血糖的不同病因,高血糖水平更可能是由ci - d引起的。结论和相关性本研究的结果表明,ICI-D是一种罕见但病态的疾病,其变化取决于ici与其他药物的联合使用。
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引用次数: 0
期刊
JAMA Oncology
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