Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Cancer Treat Rev. 2022 Jan;102:102321. doi: 10.1016/j.ctrv.2021.102321. Epub 2021 Nov 17.
Health-related quality of life (HRQOL) is increasingly recognized as important when evaluating cancer treatments. The use, reporting, and analysis of patient-reported outcome measures (PROMs), however, are not standardized in clinical trials and are often poorly implemented in clinical practice. We report the results of a systematic literature review (PubMed search: January 1, 2000 to August 15, 2020) of PROM use, reporting, and analysis in phase 3 clinical trials of hormone receptor-positive (HR+) advanced breast cancer (ABC). Further inspection of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor publications was performed to examine PROMs in the HR+/human epidermal growth factor receptor 2-negative setting. A total of 88 results were identified in the initial search; 32 were included in the final analysis. Among included studies, most (66%) had been published in the last 5 years (2015 to 2020). CDK4/6 inhibitors (38%) were the most common agents reported. No clear standard for PROM use, reporting, or analysis was found. The most common PROMs were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30; 59%) and the Functional Assessment of Cancer Therapy-Breast (FACT-B; 34%). Important differences, among studies that reported them, ranged from 5 to 10 points for the EORTC QLQ-C30 and 8 points for the FACT-B total score. This review showed that a lack of clear consistency remains for PROM use, reporting, and analysis in phase 3 clinical trials of HR+ ABC. However, HRQOL is of high interest in the literature, including for CDK4/6 inhibitors.
健康相关生活质量（HRQOL）在评估癌症治疗时越来越受到重视。然而，患者报告结局测量（PROM）的使用、报告和分析在临床试验中尚未标准化，在临床实践中通常也实施不佳。我们报告了一项系统文献综述（PubMed 检索：2000 年 1 月 1 日至 2020 年 8 月 15 日）的结果，该综述评估了激素受体阳性（HR+）晚期乳腺癌（ABC）的 3 期临床试验中 PROM 的使用、报告和分析。进一步检查了细胞周期蛋白依赖性激酶 4/6（CDK4/6）抑制剂的出版物，以研究 HR+/人表皮生长因子受体 2 阴性环境中的 PROM。在最初的搜索中确定了 88 个结果；最终分析纳入了 32 个结果。在纳入的研究中，大多数（66%）是在过去 5 年（2015 年至 2020 年）发表的。报告的最常见药物是 CDK4/6 抑制剂（38%）。没有发现 PROM 使用、报告或分析的明确标准。最常见的 PROM 是欧洲癌症研究与治疗组织生活质量问卷核心 30 （EORTC QLQ-C30；59%）和癌症治疗功能评估-乳房（FACT-B；34%）。在报告这些 PROM 的研究中，重要差异范围从 EORTC QLQ-C30 的 5 到 10 分和 FACT-B 总分的 8 分不等。这项综述表明，在 HR+ ABC 的 3 期临床试验中，PROM 的使用、报告和分析仍然缺乏明确的一致性。然而，HRQOL 在文献中很受关注，包括 CDK4/6 抑制剂。
