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帕博利珠单抗治疗晚期或复发性宫颈癌的疗效和安全性的荟萃分析。

Meta-analysis of efficacy and safety of pembrolizumab for the treatment of advanced or recurrent cervical cancer.

机构信息

Department of Pharmacy, Kunming Yan'an Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.

Department of Basic Medicine, Zhaotong Health Vocational College, Zhaotong, Yunnan, China.

出版信息

J Obstet Gynaecol. 2024 Dec;44(1):2390564. doi: 10.1080/01443615.2024.2390564. Epub 2024 Aug 16.

DOI:10.1080/01443615.2024.2390564
PMID:39150330
Abstract

BACKGROUND

This meta-analysis seeks to assess the efficacy and safety of pembrolizumab in individuals with advanced or recurrent cervical cancer.

METHODS

Databases from PubMed, Embase, and the Cochrane Library were all thoroughly searched for pertinent research. Outcomes include complete response (CR), partial response (PR), stable disease (SD), disease progression (PD), overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), median overall survival (mOS), and adverse events (AEs) were retrieved for further analysis.

RESULTS

Ten trials with 721 patients were included in this meta-analysis. The pooled results for patients with cervical cancer receiving pembrolizumab were as follows: CR (0.06, 95%CI: 0.02-0.10), PR (0.15, 95%CI: 0.08-0.22), SD (0.16, 95%CI: 0.13-0.20), PD (0.50, 95%CI: 0.25-0.75), ORR (0.26, 95%CI: 0.11-0.41) and DCR (0.42, 95%CI: 0.13-0.71), respectively. Regarding survival analysis, the pooled mPFS and mOS were 3.81 and 10.15 months. Subgroup analysis showed that pembrolizumab in combination was more beneficial in CR (0.16 vs. 0.03,  = 0.012), PR (0.24 vs. 0.08,  = 0.032), SD (0.11 vs. 0.19,  = 0.043), ORR (0.42 vs. 0.11,  = 0.014), and mPFS (5.54 months vs. 2.27 months,  < 0.001) than as single agent. The three most common AEs were diarrhoea (0.25), anaemia (0.25), and nausea (0.21), and the incidence of grade 3-5 AEs was significantly lower, rarely surpassing 0.10.

CONCLUSIONS

For patients with advanced or recurrent cervical cancer, this systematic review and meta-analysis demonstrated that pembrolizumab had a favourable efficacy and tolerability. Future research will primarily focus on optimising customised regiments that optimally integrate pembrolizumab into new therapies and combination strategies. Designed to maximise patient benefit and efficiently control adverse effects while maintaining a high standard of living.

摘要

背景

本荟萃分析旨在评估 pembrolizumab 在晚期或复发性宫颈癌患者中的疗效和安全性。

方法

全面检索了 PubMed、Embase 和 Cochrane 图书馆中的数据库,以获取相关研究。主要结局包括完全缓解(CR)、部分缓解(PR)、疾病稳定(SD)、疾病进展(PD)、总缓解率(ORR)、疾病控制率(DCR)、无进展生存期(mPFS)、总生存期(mOS)和不良事件(AE)。

结果

纳入了 10 项包含 721 例患者的临床试验进行荟萃分析。接受 pembrolizumab 治疗的宫颈癌患者的汇总结果如下:CR(0.06,95%CI:0.02-0.10)、PR(0.15,95%CI:0.08-0.22)、SD(0.16,95%CI:0.13-0.20)、PD(0.50,95%CI:0.25-0.75)、ORR(0.26,95%CI:0.11-0.41)和 DCR(0.42,95%CI:0.13-0.71)。关于生存分析,汇总的 mPFS 和 mOS 分别为 3.81 个月和 10.15 个月。亚组分析显示,pembrolizumab 联合治疗在 CR(0.16 比 0.03,  = 0.012)、PR(0.24 比 0.08,  = 0.032)、SD(0.11 比 0.19,  = 0.043)、ORR(0.42 比 0.11,  = 0.014)和 mPFS(5.54 个月比 2.27 个月,  < 0.001)方面更具优势。最常见的三种 AE 是腹泻(0.25)、贫血(0.25)和恶心(0.21),且 3-5 级 AE 的发生率明显较低,很少超过 0.10。

结论

对于晚期或复发性宫颈癌患者,本系统评价和荟萃分析表明 pembrolizumab 具有良好的疗效和耐受性。未来的研究将主要集中在优化定制方案上,将 pembrolizumab 最佳地整合到新的治疗方法和联合策略中。旨在最大限度地提高患者受益,有效地控制不良反应,同时保持高生活质量。

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