■这项荟萃分析旨在评估新辅助PD-1抑制剂或PD-L1抑制剂[PD-(L)1抑制剂]对肌肉浸润性膀胱癌(MIBC)的疗效和安全性。
■四个数据库(Medline,Embase,WebofScience,和21CENTRAL)搜索了研究MIBC新辅助PD-(L)1抑制剂的文章。搜索时间段是从每个数据库的建立到2023年7月21日。pCR的荟萃分析,pPR,≥3级irAE率,RFS,和OS进行。
■总共,纳入22项研究进行荟萃分析。新辅助PD-(L)1抑制剂的总体汇集pCR为0.36(95CI=0.30-0.42,p=0.00)。在亚组荟萃分析中,单独的PD-(L)1抑制剂的汇集PCR,PD-(L)1抑制剂加其他ICI,PD-(L)1抑制剂加化疗为0.27(95CI=0.19-0.35,p=0.1),0.41(95CI=0.21-0.62,p=0.01),0.43(95CI=0.35-0.50,p=0.06),分别。新辅助PD-(L)1抑制剂的总体汇集的pPR为0.53(95CI=0.46-0.60,p=0.00)。在亚组荟萃分析中,单独PD-(L)1抑制剂的合并pPR,PD-(L)1抑制剂加其他ICI,PD-(L)1抑制剂加化疗为0.36(95CI=0.22-0.51,p=0.01),0.51(95CI=0.39-0.62,p=0.43),和0.61(95CI=0.53-0.69,p=0.01),分别。重建了OS和RFS的Kaplan-Meier曲线,但三组间OS或RFS无显著差异。新辅助PD-(L)1抑制剂的≥3级irAE的合并结果为0.15(95CI=0.09-0.22,p=0.00%)。在亚组分析中,单独使用PD-(L)1抑制剂的≥3级irAE率的合并结果,PD-(L)1抑制剂加其他ICI,PD-(L)1抑制剂加化疗为0.07(95CI=0.04-0.11,p=0.84),0.31(95CI=0.16-0.47,p=0.06),和0.17(95CI=0.06-0.31,I2=71.27%,p=0.01),分别。
■新佐剂PD-(L)1抑制剂对肌层浸润性膀胱癌是可行且安全的。与单独的PD-(L)1抑制剂相比,PD-(L)1抑制剂加其他ICI和PD-(L)1抑制剂加化疗与较高的pCR和pPR相关,但较高的等级≥3个IRAE。OS和RFS的Kaplan-Meier曲线表明新辅助PD-(L)1抑制剂具有可接受的长期预后,但无法辨别三个新辅助治疗亚组之间的统计学差异.
■https://www.crd.约克。AC.uk/prospro/display_record.php?ID=CRD42023452437,标识符PROSPERO(CRD42023452437)。
This meta-analysis aims to evaluate the efficacy and safety of neoadjuvant PD-1 inhibitors or PD-L1 inhibitors [PD-(L)1 inhibitors] for muscle-invasive bladder carcinoma (MIBC).
Four databases (Medline, Embase, Web of Science, and 21 CENTRAL) were searched for articles studying neoadjuvant PD-(L)1 inhibitors for MIBC. The search time period was from the establishment of each database to 21 July 2023. Meta-analyses of pCR, pPR, Grade≥ 3 irAEs rate, RFS, and OS were performed.
In total, 22 studies were included for meta-analysis. The overall pooled pCR of neoadjuvant PD-(L)1 inhibitors was 0.36 (95%CI=0.30-0.42, p=0.00). In subgroup meta-analysis, the pooled PCR of PD-(L)1 inhibitors alone, PD-(L)1 inhibitors plus other ICI, and PD-(L)1 inhibitors plus chemotherapy was 0.27 (95%CI=0.19-0.35, p=0.1), 0.41 (95%CI=0.21-0.62, p=0.01), 0.43 (95%CI=0.35-0.50, p=0.06), respectively. The overall pooled pPR of neoadjuvant PD-(L)1 inhibitors was 0.53 (95%CI=0.46-0.60, p=0.00). In subgroup meta-analysis, the pooled pPR of PD-(L)1 inhibitors alone, PD-(L)1 inhibitors plus other ICI, and PD-(L)1 inhibitors plus chemotherapy was 0.36 (95%CI=0.22-0.51, p=0.01), 0.51 (95%CI=0.39-0.62, p=0.43), and 0.61 (95%CI=0.53-0.69, p=0.01), respectively. Kaplan-Meier curves for OS and RFS were reconstructed, but there was no significant difference among three groups in terms of OS or RFS. The pooled result of Grade≥ 3 irAEs rate for neoadjuvant PD-(L)1 inhibitors was 0.15 (95%CI=0.09-0.22, p=0.00%). In subgroup analysis, the pooled result of Grade≥ 3 irAEs rate for PD-(L)1 inhibitors alone, PD-(L)1 inhibitors plus other ICI, and PD-(L)1 inhibitors plus chemotherapy was 0.07 (95%CI=0.04-0.11, p=0.84), 0.31 (95%CI=0.16-0.47, p=0.06), and 0.17 (95%CI=0.06-0.31, I2 = 71.27%, p=0.01), respectively.
Neoadjuvant PD-(L)1 inhibitors were feasible and safe for muscle invasive bladder cancer. Compared with PD-(L)1 inhibitors alone, PD-(L)1 inhibitors plus other ICI and PD-(L)1 inhibitors plus chemotherapy were associated with higher pCR and pPR, but higher Grade≥3 irAEs. Kaplan-Meier curves for OS and RFS indicated that neoadjuvant PD-(L)1 inhibitors had an acceptable long-term prognostic, but it was not possible to discern statistical differences between the three neoadjuvant subgroups.
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023452437, identifier PROSPERO (CRD42023452437).