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晚期肾细胞癌患者接受免疫检查点抑制剂治疗的完全缓解:一项随机临床试验的荟萃分析。

Complete response to immune checkpoint inhibitors-based therapy in advanced renal cell carcinoma patients. A meta-analysis of randomized clinical trials.

机构信息

Medical Oncology Unit, Fondazione Policlinico A, Gemelli IRCCS, Rome, Italy.

Medical Oncology Unit, Fondazione Policlinico A, Gemelli IRCCS, Rome, Italy.

出版信息

Urol Oncol. 2020 Oct;38(10):798.e17-798.e24. doi: 10.1016/j.urolonc.2020.06.021. Epub 2020 Aug 7.

DOI:10.1016/j.urolonc.2020.06.021
PMID:32773231
Abstract

BACKGROUND

A major breakthrough with immunotherapy is its potential to achieve complete responses (CR) in a subset of advanced renal cell carcinoma (RCC) patients. We aim at evaluating the incidence and relative risk (RR) of CR in RCC patients treated with immune checkpoint inhibitors (ICIs).

MATERIALS AND METHODS

Searching the MEDLINE/PubMed, Cochrane Library and ASCO Meeting abstracts prospective studies were identified. The proportion of patients with CR events and the derived 95% confidence intervals (CIs) were calculated for each study. Combined relative risks (RRs) and 95% CIs were calculated using fixed- or random-effects methods. The analysis was performed in the intention to treat population, in the PD-L1 expressing (≥1%) RCC tumors and in patients treated with the combination of ICIs and anti-VEGFR tyrosine kinase inhibitors.

RESULTS

Six articles were considered for final analysis (total of 4.531 patients). The incidence of CR was 6.2% with ICIs and 2.6% with SOC. Treatment with ICIs significantly increased the risk of achieving CR compared to SOC (RR = 2.40; P = 0.001). This data was confirmed for patients treated with the combination of ICIs plus anti-VEGFR tyrosine kinase inhibitors (RR = 2.50; P = 0.002). In PD-L1 positive tumors, the incidence of CR was 10.0% with ICIs and 4.0% in the SOC arm (RR = 2.49; P < 0.0001).

CONCLUSIONS

ICIs provide higher rates of CR compared to SOC, even higher in patients with PD-L1 positive tumors.

摘要

背景

免疫疗法的一个主要突破是,它有可能使一部分晚期肾细胞癌(RCC)患者实现完全缓解(CR)。我们旨在评估免疫检查点抑制剂(ICI)治疗的 RCC 患者发生 CR 的发生率和相对风险(RR)。

材料和方法

检索 MEDLINE/PubMed、Cochrane 图书馆和 ASCO 会议摘要中的前瞻性研究。为每个研究计算发生 CR 事件的患者比例和得出的 95%置信区间(CI)。使用固定或随机效应方法计算合并的相对风险(RR)和 95%CI。分析是在意向治疗人群中进行的,在 PD-L1 表达(≥1%)RCC 肿瘤患者中和接受 ICI 联合抗血管内皮生长因子受体酪氨酸激酶抑制剂治疗的患者中进行。

结果

最终分析考虑了 6 篇文章(共 4531 名患者)。ICI 组的 CR 发生率为 6.2%,SOC 组为 2.6%。与 SOC 相比,ICI 治疗显著增加了实现 CR 的风险(RR=2.40;P=0.001)。这一数据在接受 ICI 联合抗血管内皮生长因子受体酪氨酸激酶抑制剂治疗的患者中得到了证实(RR=2.50;P=0.002)。在 PD-L1 阳性肿瘤患者中,ICI 组的 CR 发生率为 10.0%,SOC 组为 4.0%(RR=2.49;P<0.0001)。

结论

与 SOC 相比,ICI 提供了更高的 CR 率,在 PD-L1 阳性肿瘤患者中甚至更高。

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