在过去5年里，已经测试过几种新的免疫治疗方法来治疗转移性肾细胞癌（mRCC）。评估不同免疫治疗方案或将免疫治疗与酪氨酸激酶抑制剂（TKI）联合使用的临床试验报告显示，与单独使用TKI的标准治疗相比，临床结果有所改善。然而，为了了解新治疗对患者的全面影响，医生必须考虑对健康相关生命质量（HRQoL）的影响。由于患者报告的结果测量通常作为临床试验中的次要结果，因此它们的收集和报告是非标准化的，因此难以比较和解释。然而，来自6项临床试验的结果表明，两种免疫治疗方案在HRQoL方面表现明显优于席瑞他滨：尼伏尼加博维星（CheckMate 9ER）和阿替珠单抗加别嘌呤酸酰胺（IMmotion151）。另外两种治疗方案通常优于席瑞他滨：尼伏尼加伊匹单抗（CheckMate 214）和来那替尼加帕博利单抗（CLEAR）。三项未与席瑞他滨有差别的研究中有两项存在设计缺陷，可能已经掩盖了HRQoL的好处（JAVELIN Renal 101和KEYNOTE-426）。为了确保未来的HRQoL数据具有最高的质量，并且可比较跨试验，未来的研究应采用最佳实践来设计，分析和报告PROM。© 2023. Springer Nature Limited.

Over the past 5 years, several new immunotherapy treatments have been tested for metastatic renal cell carcinoma (mRCC). Clinical trials assessing combinations of different immunotherapies, or of an immunotherapy with a tyrosine kinase inhibitor (TKI), have reported improved clinical outcomes compared with the standard of care - that is, treatments using TKIs alone. However, to understand the holistic impact of new treatments on patients, physicians must also consider effects on health-related quality of life (HRQoL). As patient-reported outcome measures (PROMs) on HRQoL are often treated as a secondary outcome in clinical trials, their collection and reporting are non-standardized and, therefore, difficult to compare and interpret. However, results from six clinical trials indicate that two immunotherapy treatments overwhelmingly outperform sunitinib in HRQoL measurements: nivolumab plus cabozantinib (CheckMate 9ER) and atezolizumab plus bevacizumab (IMmotion151). An additional two treatments generally outperform sunitinib: nivolumab plus ipilimumab (CheckMate 214) and lenvatinib plus pembrolizumab (CLEAR). Of three studies that reported no difference from sunitinib, two suffered design flaws that might have obscured HRQoL benefits (JAVELIN Renal 101 and KEYNOTE-426). To ensure future HRQoL data are of the highest quality and comparable across trials, future studies should adopt best practices for the design, analysis and reporting of PROMs.© 2023. Springer Nature Limited.