PD-1 inhibitors plus chemotherapy as first-line therapy for stage IV ESCC.

ABSTRACT

To evaluate the anti-tumor efficacy and tolerability of programmed cell death protein 1 (PD-1) inhibitors plus chemotherapy versus chemotherapy alone as first-line therapy for unresectable esophageal squamous cell carcinoma (ESCC) patients at stage IV in a real-world cohort. All unresectable ESCC patients at stage IV who initiated first-line therapy with PD-1 inhibitors plus chemotherapy between August 2018 and March 2021 in a general hospital in China were retrospectively analyzed in this study. Propensity score matching (11) with control patients receiving chemotherapy alone was performed. Overall survival (OS) and progression-free survival (PFS) were assessed by the Kaplan-Meier method. In this study, fifty patients (n = 25 each group) were included, all of whom could be evaluated for efficacy. PD-1 inhibitors plus chemotherapy exhibited better OS than chemotherapy alone (median 15.8 vs 12.4 months, hazard ratio [HR] 0.46 [95% CI 0.23-0.95]; P = 0.036). The median PFS for the PD-1 inhibitors plus chemotherapy group was 8.7 months compared with 6.1 months for the chemotherapy group (HR 0.48 [95% CI 0.26-0.90]; P = 0.014). Adverse events (AEs) of grade 3 or above related to treatment were found in 24.0% and 32.0% of the PD-1 inhibitors plus chemotherapy and chemotherapy alone groups, respectively. PD-1 inhibitors plus chemotherapy exhibited durable anti-tumor activity and relatively controllable safety as first-line therapy for unresectable ESCC patients at stage IV, but these results need to be confirmed by further research.