Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)

项目摘要 Evolv建议提供复杂和标准化的方法来评估、监控、分析和 报告接受癌症治疗的个人经历的不良事件(AEs)。这些方法将 利用NCI通用术语标准的患者报告结果版本的潜力 不良事件(PRO-CTCAETM)提供以前无法获得的关于患者耐受性的观点 治疗(包括靶向药物、免疫疗法和其他进化疗法， 不良事件的严重性、时间和轨迹较少为人所知)。这样的信息将帮助提供商更好地 识别和支持面临停止治疗、剂量减少和治疗延误风险的患者。 具体地说，本研究的目的是：1)对CTCAE和PROCTCAE试验数据进行纵向分析 在ECOG-ACRIN癌症研究小组内进行，使用传统和创新战略 检查AE轨迹，并制定新的报告标准，以反映严重程度和波动 时间；2)检查前CTCAE和CTCAE对治疗依从性和停用的预测因素；以及3) 验证癌症治疗功能评估中的单一项目GP5的更广泛预测价值- 一般情况(FACT-G)显示可以预测服用乳腺癌的妇女的早期停止治疗 芳香酶抑制剂。这项研究还将探索两种新的PROCTCAE分数测量模型和 CTCAE评分：包括症状共同出现和累积负担指数的表型模型 (CBI)用于表征患者随时间积累的负担量。分析将包括 人口因素和保险状况，以确定潜在的差距。

Project Summary EVOLV proposes to deliver sophisticated and standardized methods for assessing, monitoring, analyzing, and reporting adverse events (AEs) experienced by individuals undergoing cancer treatment. These methods will harness the potential of the patient-reported outcomes version of the NCI Common Terminology Criteria for Adverse Events (PRO-CTCAETM) to provide previously unavailable patient perspectives on the tolerability of treatments (including targeted agents, immunotherapies, and other evolving treatments for which the type, severity, timing, and trajectory of adverse events is less known). Such information will help providers better identify and support patients at risk for treatment discontinuation, dose reductions, and treatment delays. Specifically, this study aims to: 1) perform longitudinal analyses of CTCAE and PRO-CTCAE data from trials conducted within the ECOG-ACRIN Cancer Research Group, using traditional and innovative strategies to examine AE trajectories and to produce a new reporting standard that reflects severity and fluctuations over time; 2) examine PRO-CTCAE and CTCAE predictors of treatment adherence and discontinuation; and 3) validate the broader predictive value of GP5, a single item from the Functional Assessment of Cancer Therapy- General (FACT-G) shown to predict early treatment discontinuation among women with breast cancer taking aromatase inhibitors. The study will also explore two novel measurement models for PRO-CTCAE scores and CTCAE grades: a phenotypic model including co-occurrence of symptoms and a cumulative burden index (CBI) for characterizing the quantity of burden accumulated by patients over time. Analyses will include demographic factors and insurance status to identify potential disparities.