Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2-negative breast cancer: A trajectory analysis of adverse events.
Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2-negative breast cancer: A trajectory analysis of adverse events.
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人表皮生长因子受体2阴性乳腺癌的3期临床试验中贝伐单抗和化疗的耐受性：不良事件的轨迹分析
DOI：
10.1002/cncr.33992
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发表时间：
2021-12-15
期刊：
影响因子：
6.2
通讯作者：
Wagner LI
中科院分区：
文献类型：
--
作者：
Ip EH;Saldana S;Miller KD;Carlos RC;Gareen IF;Sparano JA;Graham N;Zhao F;Lee JW;O'Connell NS;Cella D;Peipert JD;Gray RJ;Wagner LI
E5103是一项旨在评估贝伐珠单抗疗效和安全性的研究。就无侵袭性疾病生存期和总生存期的终点而言，这是一项阴性试验。当前的研究从临床结果和患者报告结果（PROs）方面考察了贝伐珠单抗及其他药物暴露的耐受性。
从不良事件通用术语标准中收集的不良事件（AEs）进行了总结，以形成每个治疗周期的不良事件概况。对所有级别和高级别的事件分别进行了分析。不良事件概况在治疗周期中的变化被描述为不同的不良事件轨迹集群。与不良事件相关的和任何原因导致的早期治疗中断被视为临床结果指标。患者报告结果使用癌症治疗功能评估 - 乳腺 + 淋巴水肿进行测量。分析了不良事件轨迹与早期治疗中断以及患者报告结果之间的关系。
所有不良事件中超过一半（57.5%）为低级别的。一组具有广泛且混合的不良事件（所有级别）轨迹级别的患者与任何原因导致的早期治疗中断（优势比[OR]，2.87；P = 0.01）以及与不良事件相关的中断（OR，4.14；P = 0.001）显著相关。与其他集群相比，该集群每个周期的所有级别不良事件数量最多。另一组在其轨迹中主要有神经性不良事件的患者与无不良事件或不良事件很少的轨迹相比，身体健康状况较差（P < 0.01）。高级别不良事件轨迹不能预测治疗中断。
全面的毒性持续累积负担（不一定都被认定为高级别不良事件）导致了早期治疗中断。有神经性所有级别不良事件的患者可能需要额外关注，以防止其身体健康状况恶化。
E5103 was a study designed to evaluate the efficacy and safety of bevacizumab. It was a negative trial for the end points of invasive disease–free survival and overall survival. The current work examines the tolerability of bevacizumab and other medication exposures with respect to clinical outcomes and patient-reported outcomes (PROs). Adverse events (AEs) collected from the Common Terminology Criteria for Adverse Events were summarized to form an AE profile at each treatment cycle. All-grade and high-grade events were separately analyzed. The change in the AE profile over the treatment cycle was delineated as distinct AE trajectory clusters. AE-related and any-reason early treatment discontinuations were treated as clinical outcome measures. PROs were measured with the Functional Assessment of Cancer Therapy–Breast + Lymphedema. The relationships between the AE trajectory and early treatment discontinuation as well as PROs were analyzed. More than half of all AEs (57.5%) were low-grade. A cluster of patients with broad and mixed AE (all-grade) trajectory grades was significantly associated with any-reason early treatment discontinuation (odds ratio [OR], 2.87; P = .01) as well as AE-related discontinuation (OR, 4.14; P = .001). This cluster had the highest count of all-grade AEs per cycle in comparison with other clusters. Another cluster of patients with primary neuropathic AEs in their trajectories had poorer physical well-being in comparison with a trajectory of no or few AEs (P < .01). A high-grade AE trajectory did not predict discontinuations. A sustained and cumulative burden of across-the-board toxicities, which were not necessarily all recognized as high-grade AEs, contributed to early treatment discontinuation. Patients with neuropathic all-grade AEs may require additional attention for preventing deterioration in their physical well-being.
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影响因子：
45.3
作者：
Miller, Kathy D.;O'Neill, Anne;Sledge, George W., Jr.
通讯作者：
Sledge, George W., Jr.
影响因子：
4.5
作者：
Kluetz, Paul G.;Kanapuru, Bindu;Coons, Stephen Joel
通讯作者：
Coons, Stephen Joel
影响因子：
10.3
作者：
Basch, Ethan;Jia, Xiaoyu;Schrag, Deborah
通讯作者：
Schrag, Deborah
影响因子：
7.2
作者：
Eton, DT;Cella, D;Wood, WC
通讯作者：
Wood, WC
DOI：
10.1056/nejmoa1110294
发表时间：
2012-03-29
期刊：
The New England journal of medicine
影响因子：
--
作者：
Rejeski WJ;Ip EH;Bertoni AG;Bray GA;Evans G;Gregg EW;Zhang Q;Look AHEAD Research Group
通讯作者：
Look AHEAD Research Group