Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
Front Immunol. 2022 Aug 17;13:986359. doi: 10.3389/fimmu.2022.986359. eCollection 2022.
Considering the striking evidence revealed by immunotherapy in advanced or metastatic bladder cancer, investigators have explored neoadjuvant immunotherapy and chemoimmunotherapy in muscle-invasive bladder cancer (MIBC). Currently, there have been a large number of studies reporting varied efficacy and safety of these approaches. Herein, we pooled the available evidence in terms of oncological outcomes (pathological complete response [pCR] and pathological partial response [pPR]) and safety outcomes (immune-related adverse events [irAEs], treatment-related adverse events [TRAEs]), through a systematic review and meta-analysis.
We searched PubMed, Embase, Cochrane Library, and American Society of Clinical Oncology meeting abstracts to identify relevant studies up to June 2022. Studies were included if they evaluated the neoadjuvant immunotherapy or chemoimmunotherapy in MIBC and reported at least the pCR.
A total of 22 records involving 843 patients were included. For pCR of immunotherapy, the pooled rate of immune checkpoint inhibitor (ICI) monotherapy and dual-ICIs therapy was 24% (95% confidence interval [CI]: 15.3% - 32.8%) and 32.1% (95%CI: 20.6% - 43.7%), respectively. For pCR of chemoimmunotherapy, the overall pooled rate was 42.6% (95% CI: 34.9% - 50.2%). Subgroup of gemcitabine/cisplatin (GC) plus ICI had a pCR rate of 41.7% (95%CI: 35.8% - 47.5%). In terms of safety, the pooled rate of Grade≥3 irAEs was 11.7% (95% CI: 6.5%-16.9%). In subgroup analysis, the Grade≥3 irAEs rate of ICI monotherapy, dual-ICIs therapy, and GC plus ICI therapy was 7.4% (95% CI: 4.3%-10.5%), 30.3% (95% CI: 15.3%-45.3%), and 14.5% (95% CI: 3.5% - 25.4%), respectively. Besides, the pooled Grade≥3 TRAEs rate for chemoimmunotherapy was 32.4% (95% CI: 13.1% - 51.6%).
Neoadjuvant immunotherapy and chemoimmunotherapy were effective and safe in the treatment of MIBC. Compared to ICI monotherapy, dual-ICIs therapy or chemoimmunotherapy can improve the response rate, while increasing the morbidity of Grade≥ 3 irAEs or Grade≥ 3 TRAEs.
https://www.crd.york.ac.uk/prospero/, identifier CRD4202233771.
鉴于免疫疗法在晚期或转移性膀胱癌中显示出的显著疗效，研究人员探索了新辅助免疫疗法和化疗免疫疗法在肌层浸润性膀胱癌（MIBC）中的应用。目前，已经有大量研究报告了这些方法的不同疗效和安全性。在此，我们通过系统评价和荟萃分析，汇总了关于肿瘤学结局（病理完全缓解[PCR]和病理部分缓解[pPR]）和安全性结局（免疫相关不良事件[irAE]、治疗相关不良事件[TRAEs]）的可用证据。
我们检索了 PubMed、Embase、Cochrane 图书馆和美国临床肿瘤学会会议摘要，以确定截至 2022 年 6 月的相关研究。如果研究评估了 MIBC 中的新辅助免疫疗法或化疗免疫疗法，并报告了至少 pCR，则将其纳入研究。
共纳入 22 项记录，涉及 843 名患者。对于免疫疗法的 pCR，单药免疫检查点抑制剂（ICI）治疗和双 ICI 治疗的汇总缓解率分别为 24%（95%置信区间[CI]：15.3%-32.8%）和 32.1%（95%CI：20.6%-43.7%）。对于化疗免疫疗法的 pCR，总体汇总缓解率为 42.6%（95%CI：34.9%-50.2%）。吉西他滨/顺铂（GC）联合 ICI 的亚组 pCR 率为 41.7%（95%CI：35.8%-47.5%）。关于安全性，≥3 级 irAE 的汇总发生率为 11.7%（95%CI：6.5%-16.9%）。在亚组分析中，ICI 单药治疗、双 ICI 治疗和 GC 联合 ICI 治疗的≥3 级 irAE 发生率分别为 7.4%（95%CI：4.3%-10.5%）、30.3%（95%CI：15.3%-45.3%）和 14.5%（95%CI：3.5%-25.4%）。此外，化疗免疫疗法的≥3 级 TRAE 发生率汇总为 32.4%（95%CI：13.1%-51.6%）。
新辅助免疫疗法和化疗免疫疗法在 MIBC 的治疗中是有效且安全的。与 ICI 单药治疗相比，双 ICI 治疗或化疗免疫疗法可以提高缓解率，同时增加≥3 级 irAE 或≥3 级 TRAE 的发病率。
https://www.crd.york.ac.uk/prospero/，标识符 CRD4202233771。
