Bing Tan, Shike Lin, Xian Wei, Shengcai Chen, Yuexiu Liang, Yan Deng
Pembrolizumab demonstrated promising efficacy and a manageable safety profile in patients with recurrent or advanced cervical cancer. Combination therapy appears to provide superior clinical benefits compared with monotherapy. Further large-scale prospective studies are warranted to confirm these findings and better identify patient subgroups that may derive the greatest benefit from pembrolizumab-based therapy.
BACKGROUND: This study aimed to evaluate the therapeutic efficacy and safety profile of pembrolizumab in patients with recurrent and advanced cervical cancer.
METHODS: A systematic literature search was conducted in six databases, including Web of Science, PubMed, Embase, Scopus, Cochrane Library, and Google Scholar, from database inception to March 2026. Studies evaluating pembrolizumab monotherapy or pembrolizumab-containing combination therapy in patients with recurrent or advanced cervical cancer were included. Pooled analyses were performed to estimate survival outcomes, tumor response rates, and adverse events using fixed-effects or random-effects models according to the degree of heterogeneity. Subgroup analyses were conducted according to study design and treatment strategy.
RESULTS: Eleven studies involving 1`111 patients with recurrent or advanced cervical cancer were included in the meta-analysis. Pooled median overall survival (mOS) was 10.82 months (95% CI:8.89-12.76), and the pooled median progression-free survival (mPFS) was 3.47 months (95% CI:2.61-4.34). The pooled overall response rate was 0.30 (95% CI:0.16-0.49), while pooled disease control rate was 0.57 (95% CI:0.36-0.76). Subgroup analyses showed that combination therapy significantly improved the mPFS and tumor response outcomes compared to monotherapy. Clinical trials have demonstrated higher response rates than retrospective studies. Pooled survival outcomes improved in PD-L1-positive patients. Regarding safety, the most common any-grade adverse events included anemia, fatigue, diarrhea, nausea, and vomiting, whereas grade 3-5 adverse events occurred at relatively low frequencies.
CONCLUSION: Pembrolizumab demonstrated promising efficacy and a manageable safety profile in patients with recurrent or advanced cervical cancer. Combination therapy appears to provide superior clinical benefits compared with monotherapy. Further large-scale prospective studies are warranted to confirm these findings and better identify patient subgroups that may derive the greatest benefit from pembrolizumab-based therapy.