帕博利珠单抗治疗宫颈癌的疗效与安全性：一项系统评价和单臂荟萃分析。
Efficacy and safety of pembrolizumab on cervical cancer: A systematic review and single-arm meta-analysis.
作者信息
Qi Lin, Li Ning, Lin Aimin, Wang Xiuli, Cong Jianglin
机构信息
Department of Gynecology and Obstetrics, Yantai Yuhuangding Hospital Affiliated to Qingdao University, Yantai, China.
出版信息
Front Oncol. 2022 Aug 10;12:910486. doi: 10.3389/fonc.2022.910486. eCollection 2022.
BACKGROUND
According to current research, the objective response rate and overall survival of pembrolizumab in the treatment of several types of solid tumors have been significantly improved. Some high-quality clinical trials have studied the effect of applying pembrolizumab in treating cervical cancer. Multiple clinical trials have been conducted, and some of them have shown good results as expected. Therefore, we performed this meta-analysis on existing studies to reveal the efficacy and safety of pembrolizumab in treating cervical cancer.
METHODS
PubMed, Embase, Cochrane Library and Web of Science were searched for literatures published until October 31, 2021. Outcomes included complete response (CR), partial response (PR), stable disease (SD), disease progression (PD), objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), the best time to response (TTR), death rate, adverse events (AE).
RESULTS
A total of 7 studies with 727 patients were included. The results were as follows: CR (0.027, 95%CI: 0.008-0.053), PR (0.104, 95% CI: 0.074-0.145), SD (0.190, 95% CI: 0.149-0.240), PD (0.541, 95% CI: 0.421-0.661). ORR was 0.155 (95% CI: 0.098-0.236) and DCR was 0.331 (95% CI: 0.277-0.385). OS was 10.23 months (95% CI: 8.96-11.50) and PFS was 4.27 months (95% CI: 1.57-6.96). TTR was 2.10 months (95%CI: 1.69-2.51). The 1-year death rate was 0.388 (95% CI: 0.230-0.574). Main adverse events included abnormal liver function, hypothyroidism, neutropenia, anemia, decreased appetite, fatigue, fever, etc. The total incidence of the adverse events of grade 3 and above was 0.212 (95% CI: 0.065-0.509).
CONCLUSIONS
Pembrolizumab provides significant benefits in response rate and survival for cervical cancer patients. The results from recent high-quality clinical trials are expected to validate these findings.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42021291723.
背景
根据目前的研究，帕博利珠单抗治疗多种实体瘤的客观缓解率和总生存期均有显著改善。一些高质量的临床试验研究了帕博利珠单抗治疗宫颈癌的效果。已经开展了多项临床试验，其中一些试验取得了预期的良好结果。因此，我们对现有研究进行了这项荟萃分析，以揭示帕博利珠单抗治疗宫颈癌的疗效和安全性。
方法
检索了截至2021年10月31日在PubMed、Embase、Cochrane图书馆和Web of Science上发表的文献。结局指标包括完全缓解（CR）、部分缓解（PR）、疾病稳定（SD）、疾病进展（PD）、客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）、无进展生存期（PFS）、最佳缓解时间（TTR）、死亡率、不良事件（AE）。
结果
共纳入7项研究，727例患者。结果如下：CR（0.027，95%CI：0.008 - 0.053），PR（0.104，95%CI：0.074 - 0.145），SD（0.190，95%CI：0.149 - 0.240），PD（0.541，95%CI：0.421 - 0.661）。ORR为0.155（95%CI：0.098 - 0.236），DCR为0.331（95%CI：0.277 - 0.385）。OS为10.23个月（95%CI：8.96 - 11.50），PFS为4.27个月（95%CI：1.57 - 6.96）。TTR为2.10个月（95%CI：1.69 - 2.51）。1年死亡率为0.388（95%CI：0.230 - 0.574）。主要不良事件包括肝功能异常、甲状腺功能减退、中性粒细胞减少、贫血、食欲下降、疲劳、发热等。3级及以上不良事件的总发生率为0.212（95%CI：0.065 - 0.509）。
结论
帕博利珠单抗在宫颈癌患者的缓解率和生存期方面提供了显著益处。预计近期高质量临床试验的结果将验证这些发现。
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