Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
Department of Gynecologic Oncology and Reproductive Medicine, Unit 1362, MD Anderson Cancer Center, P.O. Box 301439, Houston, TX 77230-1439, USA.
Nat Rev Clin Oncol. 2015 Jun;12(6):358-70. doi: 10.1038/nrclinonc.2015.29. Epub 2015 Mar 10.
Patient-reported outcome (PRO) measures, such as quality of life, have been associated with relevant clinical end points and are prognostic for survival outcomes in a variety of solid cancers in adults. In the past few years, PROs have garnered a greater influence as established and clinically relevant measures that could alter the current paradigm of practice-changing therapeutic advances, as it has been recognized that classic clinical end points do not accurately portray a full appreciation of the benefits, risks and costs of therapy. In this Review, we comprehensively assess the correlation of PROs with treatment response and survival, and explore tumour-related and patient-centric composite end points in patients with cancer participating in clinical trials. Comparisons or composite end points that consider tumour-related and PRO components might help health-care providers, patients with cancer and decision makers to better understand the total clinical benefit of therapeutic interventions.
患者报告的结局（PRO）指标，如生活质量，与相关的临床终点相关，并可预测成人各种实体瘤的生存结局。在过去几年中，PRO 作为既定的、具有临床相关性的指标，其影响越来越大，这些指标可能会改变目前改变治疗方法的范例，因为人们已经认识到，经典的临床终点并不能准确地描述治疗的益处、风险和成本的全面情况。在这篇综述中，我们全面评估了 PRO 与治疗反应和生存的相关性，并探讨了参加临床试验的癌症患者的与肿瘤相关和以患者为中心的综合终点。考虑肿瘤相关和 PRO 组成部分的比较或综合终点可能有助于医疗保健提供者、癌症患者和决策者更好地了解治疗干预的总体临床获益。
