Latin American Cooperative Oncology Group - LACOG, Porto Alegre, RS, Brazil; Hospital Santa Lucia, Brasilia, DF, Brazil; Hospital Universitário de Brasília, Brasilia, DF, Brazil.
Latin American Cooperative Oncology Group - LACOG, Porto Alegre, RS, Brazil; Hospital Albert Einstein, São Paulo, SP, Brazil; Centro Paulista de Oncologia/Grupo Oncoclínicas, São Paulo, SP Brazil.
Clin Genitourin Cancer. 2023 Jun;21(3):324-333. doi: 10.1016/j.clgc.2023.01.005. Epub 2023 Jan 20.
Pembrolizumab, a PD-1 ICI is approved for the adjuvant treatment of postnephrectomy patients with clear cell RCC in some countries worldwide. However, recent negative data from randomized clinical trials (RCT) with another ICIs makes the benefit of this treatment uncertain. A systematic review and study-level meta-analysis was performed to evaluate the benefit of disease-free survival (DFS) with adjuvant ICI treatment for patients with localized and/or metastatic resected RCC. Using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement, a systematic search was performed in PUBMED/MEDLINE, Scopus and EMBASE up to September 15, 2022. The statistical analysis was performed by ProMeta 3 software in intention-to-treat (ITT) population and in predetermined subgroups. Four RCT totalizing 3407 patients were included in this analysis. Systemic immunotherapy was pembrolizumab, atezolizumab, nivolumab, and ipilimumab plus nivolumab in 496, 390, 404, and 405 patients, respectively. In the ITT population there was a nonstatistically significant DFS benefit with adjuvant ICI (HR: 0.85, 95% CI: 0.69-1.04). Regarding the subgroups, there was a DFS benefit for PD-L1 positive (HR: 0.72; 95% CI: 0.55-0.94), intermediate-high risk patients (HR: 0.77; 95% CI: 0.63-0.94), and patients with sarcomatoid component (HR: 0.66; 95% CI: 0.43-0.99). This meta-analysis did not demonstrate a statistically significant DFS benefit in overall population, however considering the heterogeneity between the RCTs the use of adjuvant ICI should be individualized.
派姆单抗，一种 PD-1 ICI，在全球一些国家被批准用于辅助治疗肾细胞癌（RCC）患者的肾切除术后。然而，最近另一种 ICI 的随机临床试验（RCT）的阴性数据使得这种治疗的益处不确定。进行了一项系统评价和研究水平的荟萃分析，以评估辅助 ICI 治疗对局限性和/或转移性 RCC 切除患者无病生存（DFS）的益处。使用系统评价和荟萃分析的首选报告项目（PRISMA）声明，在 2022 年 9 月 15 日之前，在 PUBMED/MEDLINE、Scopus 和 EMBASE 中进行了系统搜索。在意向治疗（ITT）人群中和预定的亚组中，使用 ProMeta 3 软件进行了统计分析。这项分析共纳入了四项 RCT，总计 3407 例患者。全身免疫治疗分别为派姆单抗、阿替利珠单抗、纳武单抗和伊匹单抗加纳武单抗，分别用于 496、390、404 和 405 例患者。在 ITT 人群中，辅助 ICI 有非统计学显著的 DFS 获益（HR：0.85，95%CI：0.69-1.04）。关于亚组，PD-L1 阳性（HR：0.72；95%CI：0.55-0.94）、中高危患者（HR：0.77；95%CI：0.63-0.94）和存在肉瘤样成分的患者（HR：0.66；95%CI：0.43-0.99）有 DFS 获益。这项荟萃分析并未在总体人群中显示出统计学显著的 DFS 获益，但考虑到 RCT 之间的异质性，辅助 ICI 的使用应该个体化。
