卡瑞利珠单抗治疗宫颈癌的疗效与安全性：一项系统评价与荟萃分析。
Efficacy and safety of camrelizumab for the treatment of cervical cancer: a systematic review and meta-analysis.
作者信息
Mi Xiaodong, Tuo Fei, Lin Tong
机构信息
Department of Obstetrics and Gynecology, First Affiliated Hospital of Jishou University, Jishou, Hunan, China.
出版信息
Front Oncol. 2024 Dec 24;14:1526103. doi: 10.3389/fonc.2024.1526103. eCollection 2024.
BACKGROUND
Cervical cancer (CC) is a prevalent malignancy in women and ranks fourth in global cancer-related mortality. The prognosis for women with metastatic or recurring cervical cancer is unfavorable. Camrelizumab is a humanized high-affinity IgG4-kappa monoclonal antibody targeting programmed cell death 1 (PD-1), which has been progressively documented as a therapy for advanced cervical cancer with good result metrics. Nonetheless, a comprehensive investigation of Camrelizumab's efficacy in treating cervical cancer has yet to be conducted.
METHODS
We conducted a search across PubMed, Ovid Medline, Embase, Web of Science, Cochrane Library, Scopus, ProQuest, CNKI, Wan Fang, VIP database, and CBMdisc, restricting the establishment date of the databases to October 2024. The ROBINS-I Scale was utilized to evaluate the methodological quality of the included studies. Furthermore, information about CR, PR, SD, PD, ORR, DCR, median OS, median PFS, adverse events (AEs), and other relevant data was obtained. A meta-analysis was performed utilizing a random-effects model and effect size for illness.
RESULTS
This meta-analysis included six trials, including 238 people with CC. The aggregated outcomes for patients were as follows: CR (0.097, 95% CI: 0.032-0.186), PR (0.465, 95% CI: 0.291-0.638), SD (0.264, 95% CI: 0.124-0.403), PD (0.174, 95% CI: 0.051-0.296), ORR (0.577, 95% CI: 0.354-0.799), DCR (0.784, 95% CI: 0.652-0.916), AEs (all grades: 0.836, 95% CI: 0.629-1.000, ≥grade III: 0.472, 95% CI: 0.111-0.834). The predominant treatment-related adverse events included anemia (≤grade II: 0.295, 95% CI: 0.187-0.402; ≥grade III: 0.124, 95% CI: 0.018-0.230), elevated aspartate aminotransferase (≤grade II: 0.196, 95% CI: 0.013-0.380; ≥grade III: 0.030, 95% CI: 0.007-0.053), neutropenia (≤grade II: 0.206, 95% CI: 0.150-0.261; ≥grade III: 0.114, 95% CI: 0.066-0.162), thrombocytopenia (≤grade II: 0.295, 95% CI: 0.187-0.402), and fatigue (≤grade II: 0.174, 95% CI: 0.046-0.303).
CONCLUSIONS
This meta-analysis demonstrates that camrelizumab is efficacious and well-tolerated in patients with cervical cancer.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42024527065.
背景
宫颈癌（CC）是女性中一种常见的恶性肿瘤，在全球癌症相关死亡率中排名第四。转移性或复发性宫颈癌女性的预后不佳。卡瑞利珠单抗是一种靶向程序性细胞死亡蛋白1（PD-1）的人源化高亲和力IgG4-κ单克隆抗体，越来越多的文献记载其作为晚期宫颈癌的治疗方法，疗效指标良好。尽管如此，尚未对卡瑞利珠单抗治疗宫颈癌的疗效进行全面研究。
方法
我们在PubMed、Ovid Medline、Embase、Web of Science、Cochrane图书馆、Scopus、ProQuest、中国知网、万方、维普数据库和中国生物医学文献数据库中进行了检索，将数据库的建立日期限制在2024年10月。采用ROBINS-I量表评估纳入研究的方法学质量。此外，获取了有关完全缓解（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）、中位总生存期（OS）、中位无进展生存期（PFS）、不良事件（AE）及其他相关数据。使用随机效应模型和疾病效应大小进行荟萃分析。
结果
该荟萃分析纳入了6项试验，包括238例宫颈癌患者。患者的汇总结果如下：CR（0.097，95%置信区间：0.032 - 0.186），PR（0.465，95%置信区间：0.291 - 0.638），SD（0.264，95%置信区间：0.124 - 0.403），PD（0.174，95%置信区间：0.051 - 0.296），ORR（0.577，95%置信区间：0.35 '4 - 0.799），DCR（0.784，95%置信区间：0.652 - 0.916），AE（所有级别：0.836，95%置信区间：0.629 - 1.000，≥3级：0.472，95%置信区间：0.111 - 0.834）。主要的治疗相关不良事件包括贫血（≤2级：0.295，95%置信区间：0.187 - 0.402；≥3级：0.124，95%置信区间：0.018 - 0.230）、天冬氨酸转氨酶升高（≤2级：0.196，95%置信区间：0.013 - 0.380；≥3级：0.030，95%置信区间：0.007 - 0.053）、中性粒细胞减少（≤2级：0.206，95%置信区间：0.150 - 0.261；≥3级：0.114，95%置信区间：0.066 - 0.162）、血小板减少（≤2级：0.295，95%置信区间：0.187 - 0.402）和疲劳（≤2级：0.174，'95%置信区间：0.046 - 0.303）。
结论
该荟萃分析表明，卡瑞利珠单抗对宫颈癌患者有效且耐受性良好。
系统评价注册
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