Adverse events associated with immune checkpoint inhibitors in cervical cancer: A systematic review and meta-analysis...

This study aimed to assess the incidence of adverse events (AEs) related to immune checkpoint inhibitors (ICIs) in cervical cancer (CC) therapy and provide clinical recommendations to ensure their safe, rational, and effective use.

This systematic review was registered on PROSPERO under the registration number CRD420251133016. A systematic search following the PICO guidelines was conducted across PubMed (n = 71), Embase (n = 321), Web of Science (n = 174), and the Cochrane Library (n = 291) databases from May 30, 2026, without any language limitations. Inclusion criteria encompassed randomized controlled phase III trials (RCTs) that reported treatment-related adverse events (trAEs) or immune-related adverse events (irAEs) in the context of ICI-based cervical cancer treatments.

Five RCTs involving a total of 3,302 patients satisfied the eligibility criteria. When compared to the control group consisting of standard chemoradiotherapy or chemotherapy, the incidence of trAEs of any grade or treatment-related death was not found to be significantly associated with immune checkpoint inhibitors (RR: 1.00, [95 % CI] 0.99 to 1.01, p = 0.98; RR: 1.44, [95 % CI] 0.69 to 2.97, p = 0.33, respectively). But, the incidence of grade 3 or higher trAEs, irAEs of any grade, grade 3 or higher irAEs, and treatment-related discontinuation was significantly associated with immune checkpoint inhibitors compared with placebo (RR: 1.07, [95 % CI] 1.03 to 1.11, p = 0.001; RR: 2.80, [95 % CI] 1.71 to 4.58, p < 0.001; RR: 4.60, [95 % CI] 2.70 to 7.84, p < 0.001; RR: 1.41, [95 % CI] 1.08 to 1.84p = 0.01, respectively).

This meta-analysis summarizes the AE profile of ICIs in cervical cancer treatment. These results indicate that ICI-based regimens exhibit comparable overall general toxicity to standard cervical cancer therapies. Nevertheless, the increased immune-related and high-grade toxicities constitute unique safety risks of ICIs. Close clinical monitoring and targeted toxicity management are therefore essential to ensure the safe and stable clinical application of ICIs in cervical cancer treatment.