Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata (AOUI), University of Verona, Italy; Oncology Unit, Università Cattolica del Sacro Cuore, Fondazione Policlinico "A. Gemelli", Rome, Italy.
Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata (AOUI), University of Verona, Italy.
Cancer Treat Rev. 2018 Nov;70:112-117. doi: 10.1016/j.ctrv.2018.08.007. Epub 2018 Aug 20.
Recently, immune checkpoint inhibitors against PD-1/PD-L1 or CTLA4 have emerged as new treatments for metastatic renal cell carcinoma (mRCC), despite discrepancy between their effects on OS and PFS. We performed a meta-analysis of randomized trials comparing immunotherapy to standard of care (SOC) in mRCC.
Searching the MEDLINE/PubMed, Cochrane Library and ASCO Meeting abstracts prospective studies were identified. Data extraction was conducted according to the PRISMA statement. The measured outcomes were OS, PFS, and ORR.
A total of 2832 patients were available for evaluation of OS, and 3033 for PFS and ORR. Compared to SOC, immunotherapy improved OS (HR = 0.75; 95%CI 0.66-0.85; p < 0.001), and PFS (HR = 0.88; 95%CI 0.80-0.97; p = 0.009). The PFS benefit was not confirmed when considering patients treated in first-line only (p = 0.10). Conversely, significant ORR improvement was found in patients treated in first-line only (HR = 1.14; 95%CI 1.02-1.28; p = 0.03) but not in the overall population.
Immunotherapy improved OS compared to SOC in mRCC, irrespective of treatment line. In first-line, immunotherapy also increased the ORR compared to sunitinib. A lack of correlation between OS and PFS was confirmed, the latter to be used cautiously for the design and interpretation of trials involving immunotherapy in mRCC.
最近，针对 PD-1/PD-L1 或 CTLA4 的免疫检查点抑制剂已成为转移性肾细胞癌 (mRCC) 的新治疗方法，尽管它们对 OS 和 PFS 的影响存在差异。我们对比较免疫疗法与 mRCC 标准治疗 (SOC) 的随机试验进行了荟萃分析。
检索 MEDLINE/PubMed、Cochrane 图书馆和 ASCO 会议摘要的前瞻性研究。根据 PRISMA 声明进行数据提取。测量结果为 OS、PFS 和 ORR。
共有 2832 名患者可评估 OS，3033 名患者可评估 PFS 和 ORR。与 SOC 相比，免疫疗法改善了 OS（HR=0.75；95%CI 0.66-0.85；p<0.001）和 PFS（HR=0.88；95%CI 0.80-0.97；p=0.009）。仅考虑一线治疗的患者时，未确认 PFS 获益（p=0.10）。相反，仅在一线治疗的患者中发现 ORR 显著改善（HR=1.14；95%CI 1.02-1.28；p=0.03），但在总体人群中没有发现。
免疫疗法与 mRCC 中的 SOC 相比改善了 OS，无论治疗线如何。在一线治疗中，与舒尼替尼相比，免疫疗法也增加了 ORR。证实了 OS 和 PFS 之间缺乏相关性，后者在设计和解释涉及 mRCC 免疫疗法的试验时应谨慎使用。
