Combination therapy with immune checkpoint inhibitors in recurrent or metastatic squamous cell carcinoma of the head and neck: A meta-analysis.

Abstract

To evaluate the efficacy and safety of immune checkpoint inhibitor (ICI) combination therapy in the first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN). We conducted a meta-analysis between ICI combination therapy and standard of care (SOC) treatment (chemotherapy with or without cetuximab) in R/M-SCCHN based on randomized controlled trials (RCTs). The outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Five RCTs involving 2576 patients were included in the analysis. Compared with SOC, PD-1 inhibitor plus chemotherapy significantly improved OS (hazard ratio [HR], 0.73, 95% CI 0.62-0.87, p=0.0004), PFS (HR, 0.65, 95% CI 0.43-0.99, p=0.04) and ORR (risk ratio [RR], 1.10; 95% CI 1.01-1.19, p=0.02) of patients, while double-agent immunotherapy could not improve either the outcome of OS, PFS, or ORR (all p>0.05). In safety analyses, combination immunotherapy showed similar risks of grade 3 or higher treatment-related AEs (RR, 0.79, 95% CI 0.56-1.11, P=0.17) and treatment-related deaths (RR, 1.16, 95% CI 0.65-2.07, P=0.63) compared to SOC. Compared with SOC, PD-1 inhibitor plus chemotherapy enhanced OS, PFS, and ORR in the first-line treatment for patients with R/M-SCCHN, but double-agent immunotherapy showed no more benefit for these patients.