Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Department of Medicine, Division of Medical Oncology and Hematology, University of Toronto, Toronto, Ontario, Canada.
Cancer. 2021 May 1;127(9):1360-1368. doi: 10.1002/cncr.33457. Epub 2021 Mar 4.
Immuno-oncology therapies have been approved for various solid tumors; however, the high cost of these treatments and their potential toxicities require a thorough assessment of their risks and benefits. Collection of data directly from patients through patient-reported outcome instruments can improve the precision and reliability of adverse event detection, assess tolerability of adverse events, and provide an evaluation of health-related quality of life (HRQOL) changes from immuno-oncology therapies. There is robust development in HRQOL tools specifically for patients treated with immuno-oncology agents. This review examines the history and basic concepts of HRQOL and patient-reported outcome assessments commonly used in oncological trials, highlighting the strengths and weaknesses of current approaches when applied to immunotherapies, as well as some of the current efforts to develop tools for this field and opportunities for future research. LAY SUMMARY: Immuno-oncology (IO) therapies are costly and carry potential toxicities known as immune-related adverse events. Evaluation of health-related quality of life (HRQOL) can impact the risk-benefit assessment of IO therapies. Integration of HRQOL end points and patient-reported outcome data for IO therapies are urgently needed. Ongoing robust development of patient-reported outcome tools specific to IO therapies are currently underway and will permit the evaluation of HRQOL for IO agents. Improvement in precision and reliability of HRQOL evaluation will enhance the ultimate true value of these expensive and effective drugs.
免疫肿瘤疗法已被批准用于各种实体瘤；然而，这些治疗方法的高成本及其潜在的毒性需要对其风险和益处进行全面评估。通过患者报告的结果工具直接从患者那里收集数据，可以提高不良事件检测的准确性和可靠性，评估不良事件的耐受性，并对免疫肿瘤疗法引起的健康相关生活质量（HRQOL）变化进行评估。专门针对接受免疫肿瘤药物治疗的患者的 HRQOL 工具得到了蓬勃发展。这篇综述考察了 HRQOL 和患者报告的结果评估在肿瘤学试验中常用的历史和基本概念，强调了当前方法在应用于免疫疗法时的优缺点，以及为该领域开发工具的一些当前努力和未来研究的机会。
免疫肿瘤学（IO）疗法成本高昂，且具有免疫相关不良反应等潜在毒性。健康相关生活质量（HRQOL）的评估可能会影响 IO 疗法的风险效益评估。急需将 IO 疗法的 HRQOL 终点和患者报告的结果数据相结合。目前正在进行专门针对 IO 疗法的患者报告结果工具的持续有力开发，这将允许对 IO 药物的 HRQOL 进行评估。提高 HRQOL 评估的准确性和可靠性将提高这些昂贵且有效的药物的最终真正价值。
