Abstract
OBJECTIVE: To systematically evaluate the incidence of tuberculosis (TB) in cancer patients treated with immune checkpoint inhibitors (ICIs) and compare the risk of TB between ICI-treated and non-ICI-treated cancer patients, so as to provide evidence-based support for TB prevention and control in cancer patients undergoing ICI therapy. METHODS: We searched the English databases including PubMed, Embase, and Cochrane Library from their inception to April 2025 for cohort studies or case-control studies that reported TB occurrence in cancer patients after ICI treatment or compared TB risk between ICI-treated and non-ICI-treated groups. Two independent researchers conducted literature screening, data extraction, and quality assessment using the Newcastle-Ottawa Scale (NOS) or Cochrane Risk of Bias Tool. Meta-analysis was performed using RevMan 5.4 and Stata 16.0 software. The pooled incidence of TB with 95% confidence interval (95%CI) in ICI-treated cancer patients was calculated; the relative risk (RR) with 95%CI was pooled to compare TB risk between the ICI and non-ICI groups. Funnel plots and Egger's test were used to assess publication bias. RESULTS: A total of 10 studies were included, involving 10,196 cancer patients in the ICI group and 147,528 cancer patients in the non-ICI group. Meta-analysis results showed that: ① The pooled incidence of TB in cancer patients after ICI treatment was 0.63% (95%CI: 0.47%, 0.80%); ② There was no significant difference in TB risk between the ICI group and the non-ICI group (pooled RR = 3.16, 95%CI: 0.44, 22.64, P = 0.138), with substantial heterogeneity (I²=97.1%, P<0.001). Subsequent subgroup analysis revealed that a history of TB was a critical effect modifier, with TB risk significantly elevated in the ICI group only among studies that included patients with prior TB (RR = 7.32, 95%CI:1.19, 45.12). CONCLUSION: Current evidence indicates that in the overall cancer population, ICI treatment was not associated with a significantly increased risk of TB compared to non-ICI regimens. Importantly, patients with a history of prior TB were found to be at significantly higher risk. This highlights the critical need for enhanced TB screening and vigilant monitoring, especially in this vulnerable subgroup, to mitigate TB-related adverse outcomes.