Comparative efficacy and safety of low dose vs. standard-dose immune checkpoint inhibitors: A systematic review and meta-analysis

Several studies have reported that low-dose of programmed cell death-1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors is effective. However, it is unknown whether the efficacy of low dose is as effective as standard dose. We compared the efficacy of PD-1/PD-L1 inhibitor at different doses as a single agent for patients with solid tumors. We searched published clinical trials with the clinical outcomes of PD-1/PD-L1 inhibitor until December 1, 2024. The low dose is defined as lower than the dose approved by FDA. A total of 1,084 patients from 14 studies were included in the analysis. The pooled analysis of seven studies demonstrated no significant difference in overall survival (OS) between the low dose and standard dose of PD-1/PD-L1 inhibitor. Safety evaluations from five studies indicated no significant differences in adverse events (AEs). Our study indicated that low dose of PD-1/PD-L1 inhibitor as monotherapy can provide comparable efficacy and safety to standard dose in patients with solid tumors.