Efficacy and Safety of Immune Checkpoint Inhibitors for Recurrent or Metastatic Cervical Cancer: A Systematic Review and Meta-Analysis

Vollständiger Abstract

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Background: Cervical cancer is a major global health challenge and requires the exploration of novel treatment strategies. Immune checkpoint inhibitors, particularly those targeting Programmed Death 1 (PD-1) and Programmed Death-Ligand 1 (PD-L1), have emerged as promising therapeutic agents in oncology. This study aimed to evaluate the efficacy and safety of these inhibitors in the treatment of cervical cancer. Methods: A comprehensive literature search was conducted across PubMed, Embase, Web of Science, Scopus, the Cochrane Library, and the China National Knowledge Infrastructure to identify studies published up to November 1, 2024. A total of 26 relevant studies were included, including 21 Non-Randomized Controlled Trials (Non-RCTs) and 5 Randomized Controlled Trials (RCTs). The analysis primarily evaluated the efficacy and safety of PD-1/PD-L1 inhibitors in patients with advanced cervical cancer. The primary outcomes included the objective response rate, disease control rate, progression-free survival, overall survival, and adverse events. Non-RCTs and RCTs were evaluated using ROBINS-I and ROB 2, respectively. Data analysis and visualization were performed using STATA 17.0 and GraphPad. This study has been registered with PROSPERO (registration number CRD42024510357). Results: Therapeutic outcomes indicated that the objective response rate in patients with cervical cancer was 44.30% (95% CI 31.06%–57.93%), and the disease control rate was 63.05% (95% CI 51.67%–73.78%). The complete response, partial response, stable disease, and progressive disease rates were 12.58% (95% CI 6.46%–20.13%), 26.87% (95% CI 19.92%–34.40%), 17.95% (95% CI 12.50%–24.07%), and 27.61% (95% CI 17.68%–38.71%), respectively. The median PFS was 6.22 months (95% CI 3.86–8.59), with 6- and 12-month PFS rates of 58.93% (95% CI 47.78%–69.65%) and 45.20% (95% CI 32.73%–57.96%), respectively. The median OS was 14.81 months (95% CI 8.45–21.16), with 6- and 12-month OS rates of 86.57% (95% CI 80.92%–91.42%) and 70.34% (95% CI 61.47%–78.53%), respectively. Regarding safety, the incidence of treatment-related adverse events was 83.24% (95% CI 73.93%–90.94%), serious adverse events was 25.71% (95% CI 15.33%–37.58%), adverse drug reactions was 71.57% (95% CI 57.61%–83.78%), and immunerelated adverse events was 34.26% (95% CI 27.11%–41.76%). Common treatment-related adverse events included anemia, diarrhea, nausea, and leukopenia. Conclusion: The findings indicate that immune checkpoint inhibitors represent a potentially effective treatment option for patients with cervical cancer; however, their safety profile warrants careful consideration. Combination therapies involving PD-1 inhibitors appear to improve efficacy while maintaining manageable safety.