Proportional Incidence of Tuberculosis in Cancer Patients Receiving Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis

Abstract

The aim of this systematic review and meta-analysis was to estimate the pooled proportional incidence of tuberculosis (TB) in cancer patients treated with immune checkpoint inhibitors (ICIs). PubMed, Embase, and the Cochrane Library were searched from inception through December 31, 2025. Cohort and pharmacovigilance studies reporting TB events in ICI-treated cancer patients were included. Twelve cohort studies (19,879 patients and 233 TB events) constituted the primary analysis; two pharmacovigilance studies (193,262 reports and 146 TB events) were analyzed separately due to incompatible denominators. In the primary cohort analysis (k = 12), the pooled incidence of TB was 0.80% (95% confidence interval [CI]: 0.45%–1.42%; I 2 = 81.9%). Patients with lung cancer (k = 8) demonstrated a consistent incidence of 1.34% (95% CI: 1.01%–1.77%; I 2 = 0%) across five countries (Japan, South Korea, Singapore, China, and Taiwan). A complementary incidence rate meta-analysis (k = 4) yielded 1.14 events per 100 person-years (95% CI: 0.55–2.38). Pharmacovigilance Food and Drug Administration adverse event reporting system estimates were lower (0.06%–0.10%), consistent with the expected underreporting inherent in voluntary surveillance systems. Publication bias was not substantial (Egger P = 0.055; Peters P = 0.767). TB occurred in 0.80%–1.34% of the patients receiving ICIs, with the greatest consistency in those with lung cancer. Excess risk attributable specifically to ICIs above the elevated cancer baseline remains uncertain. Because this proportional analysis is descriptive, routine TB screening before ICI initiation cannot be recommended on current evidence; further prospective comparative studies are needed to clarify this issue.