INTRODUCTION: Antibody-drug conjugates (ADCs) have radically transformed the therapeutic landscape for cancer treatment, but little is known about the treatment-related fatal adverse events (FAEs). We aimed to comprehensively investigate the safety of ADCs regarding treatment-related FAEs. METHODS: We conducted a systematic search of PubMed, Embase, and the Cochrane database for randomized controlled trials (RCTs) of ADCs. The meta-analysis assessed the incidence of treatment-related FAEs and the odds ratio (OR) in the ADCs group compared with the control group. RESULTS: A total of 49 RCTs involving 13,052 patients treated with ADCs were included. The incidence of treatment-related FAEs in the ADCs group was 0.62% (95% CI = 0.36-1.08), while the control group was 0.52% (95% CI = 0.29-0.95), with an OR of 1.41 (95% CI = 1.12-1.79
CONCLUSIONS: The meta-analysis of RCTs found that ADCs were associated with an increased risk of treatment-related FAEs compared with the control group. Moreover, the occurrence of treatment-related FAEs was associated with specific types of ADCs.