Efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy ± bevacizumab for recurrent or metastatic cervical cancer: a systematic review and meta-analysis of randomized controlled trials.
完整摘要 · 中文译文
背景：在复发性或转移性宫颈癌中，在化疗±贝伐珠单抗基础上加用PD-1/PD-L1抑制剂的疗效正在积极研究中。 目的：通过对随机对照试验（RCTs）进行荟萃分析，系统评价PD-1/PD-L1抑制剂联合化疗±贝伐珠单抗在该情形下的疗效和安全性。 方法：系统检索PubMed、Embase、Web of Science、Cochrane Library、Scopus和ClinicalTrials.gov中截至2026年1月14日发表的RCTs。主要结局为总生存期（OS）和无进展生存期（PFS）；风险比（HRs）由重建的Kaplan-Meier曲线得出。 结果：共纳入6项RCTs，涉及2,242例患者：1,131例接受PD-1/PD-L1抑制剂联合化疗±贝伐珠单抗，1,111例仅接受化疗±贝伐珠单抗。联合方案显著延长中位OS（28.7 vs. 19.4个月）和中位PFS（12.0 vs. 8.7个月）。完全缓解、部分缓解、疾病稳定、疾病进展和客观缓解率的合并风险比（RRs）分别为1.606（95% CI，1.333-1.936）、1.127（95% CI，0.994-1.277）、0.733（95% CI，0.612-0.878）、0.460（95% CI，0.305-0.695）和1.235（95% CI，1.153-1.322）。任何级别不良事件的风险在两组间无显著差异（RR 0.999，95% CI 0.991-1.008），而联合治疗与≥3级不良事件风险增加相关（RR 1.069，95% CI 1.019-1.121）。常报告的不良反应包括恶心、贫血、便秘 n、关节痛、中性粒细胞减少、高血压、脱发和周围神经病变。 结论：在复发或转移性宫颈癌患者中，在化疗±贝伐珠单抗的基础上加用PD-1/PD-L1抑制剂可显著改善OS和PFS，但高级别毒性反应略有增加。 系统评价注册：https://www.crd.york.ac.uk/PROSPERO/view/，注册号CRD420261472748。
完整摘要 · 英文原文
BACKGROUND: The efficacy of adding PD-1/PD-L1 inhibitors to chemotherapy ± bevacizumab in recurrent or metastatic cervical cancer is under active investigation. OBJECTIVE: To systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy ± bevacizumab in this setting through a meta-analysis of randomized controlled trials (RCTs). METHODS: A systematic search of PubMed, Embase, Web of Science, Cochrane Library, Scopus, and ClinicalTrials.gov was conducted for RCTs published up to January 14, 2026. Primary outcomes were overall survival (OS) and progression-free survival (PFS); hazard ratios (HRs) were derived from reconstructed Kaplan-Meier curves. RESULTS: Six RCTs involving 2,242 patients were included: 1,131 received PD-1/PD-L1 inhibitors plus chemotherapy ± bevacizumab, and 1,111 received chemotherapy ± bevacizumab alone. The combination regimen significantly prolonged median OS (28.7 vs. 19.4 months) and median PFS (12.0 vs. 8.7 months). Pooled risk ratios (RRs) for complete response, partial response, stable disease, progressive disease, and objective response rate were 1.606 (95% CI, 1.333-1.936), 1.127 (95% CI, 0.994-1.277), 0.733 (95% CI, 0.612-0.878), 0.460 (95% CI, 0.305-0.695), and 1.235 (95% CI, 1.153-1.322), respectively. The risk of any-grade adverse events did not differ significantly between groups (RR 0.999, 95% CI 0.991-1.008), whereas the combination was associated with an increased risk of grade ≥3 adverse events (RR 1.069, 95% CI 1.019-1.121). Frequently reported adverse reactions included nausea, anemia, constipation, arthralgia, neutropenia, hypertension, alopecia, and peripheral neuropathy. CONCLUSION: In patients with recurrent or metastatic cervical cancer, the addition of PD-1/PD-L1 inhibitors to chemotherapy ± bevacizumab significantly improves OS and PFS, though with a modest increase in high-grade toxicity. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420261472748.
摘要 待译
BACKGROUND: The efficacy of adding PD-1/PD-L1 inhibitors to chemotherapy ± bevacizumab in recurrent or metastatic cervical cancer is under active investigation. OBJECTIVE: To systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy ± bevacizumab in this setting through a meta-analysis of randomized controlled trials (RCTs). METHODS: A systematic search of PubMed, Embase, Web of Science, Cochrane Library, Scopus, and ClinicalTrials.gov was conducted for RCTs published up to January 14, 2026.…