Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Hoag Family Cancer Institute, Newport Beach, CA, USA.
Nat Rev Urol. 2023 Jul;20(7):420-433. doi: 10.1038/s41585-023-00747-w. Epub 2023 Mar 16.
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.
在过去的 5 年中，已经有几种新的免疫疗法治疗转移性肾细胞癌（mRCC）进行了测试。评估不同免疫疗法联合治疗或免疫疗法联合酪氨酸激酶抑制剂（TKI）的临床试验报告称，与标准治疗（即单独使用 TKI 的治疗）相比，临床结果得到了改善。然而，为了了解新治疗方法对患者的整体影响，医生还必须考虑对健康相关生活质量（HRQoL）的影响。由于患者报告的结局测量（PROMs）通常在临床试验中被视为次要结局，因此其收集和报告是非标准化的，因此难以比较和解释。然而，六项临床试验的结果表明，两种免疫疗法在 HRQoL 测量方面明显优于舒尼替尼：纳武利尤单抗加卡博替尼（CheckMate 9ER）和阿替利珠单抗加贝伐珠单抗（IMmotion151）。另外两种治疗方法通常优于舒尼替尼：纳武利尤单抗加伊匹单抗（CheckMate 214）和仑伐替尼加 pembrolizumab（CLEAR）。在报告与舒尼替尼无差异的三项研究中，有两项研究存在设计缺陷，可能掩盖了 HRQoL 获益（JAVELIN Renal 101 和 KEYNOTE-426）。为了确保未来的 HRQoL 数据具有最高质量并在试验之间具有可比性，未来的研究应采用最佳实践来设计、分析和报告 PROMs。
