Abstract
BACKGROUND: Programmed cell death protein 1 (PD-1) inhibitors are commonly used worldwide for the management of non-small cell lung cancer (NSCLC). However, it remains unclear whether pembrolizumab and sintilimab, two of the most widely used PD-1 inhibitors in China, have significantly different effects on patients with NSCLC. A multicenter retrospective cohort study was designed and implemented using propensity-score matching (PSM) analysis to compare the effectiveness and safety profiles of pembrolizumab and sintilimab in patients with advanced NSCLC undergoing comprehensive therapy. METHODS: A total of 225 patients who received comprehensive therapy including pembrolizumab (n = 127) or sintilimab (n = 98), from 1 January to 31 December 2020 and met the eligibility criteria were included. PSM analysis (1:1) was performed to balance potential baseline confounding factors. For both treatments, Kaplan-Meier analysis and Cox regression were used to compare 1-year progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR), and rates of all adverse events (AEs). RESULTS: PSM analysis resulted in 63 matched pairs of patients. After PSM, the median PFS was 8.68 months in the sintilimab group and 9.46 months in the pembrolizumab group. The 1-year PFS showed no significant difference between the pembrolizumab and sintilimab groups before and after PSM (P = 0.873 and P = 0.574, respectively). Moreover, within the matched cohort, the pembrolizumab group had an ORR of 30.2% and a DCR of 84.1%, whereas the sintilimab group exhibited an ORR of 41.3% and a DCR of 88.9%. There were no significant differences in the ORR and DCR between the two groups (P = 0.248 and P = 0.629, respectively). The incidence of grade 3 or 4 treatment-related AEs was significantly higher in the pembrolizumab group than that in the sintilimab group (42.9% vs. 33.3%, P = 0.043). Multivariable Cox proportional hazards regression analysis indicated that the lines of treatment and regimens significantly influenced the PFS of patients (P <0.05). CONCLUSIONS: This study demonstrated the similar effectiveness of sintilimab and pembrolizumab in the treatment of patients with advanced NSCLC, with sintilimab potentially displaying a superior clinical safety profile. CLINICAL TRIAL REGISTRATION: https://www.medicalresearch.org.cn/, identifier MR4423000113.