Comparison of Efficacy and Safety of Anti-Programmed Cell Death-1 Antibody Plus Lenvatinib and Chemotherapy as First-Line Therapy for Patients with Stage IV Gallbladder Cancer: A Real-World Study in a Chinese Population.

Background: The present study aimed to evaluate and compare the efficacy and safety of anti-programmed cell death protein 1 (anti-PD-1) antibody plus lenvatinib (tyrosine kinase inhibitor) therapy and chemotherapy as the first-line treatment to unresectable stage IV gallbladder cancer (GBC). Methods: We retrospectively analyzed the clinical data of patients with stage IV GBC who received chemotherapy or anti-PD-1 antibody combined with lenvatinib therapy at our hospital from March 2018 to October 2022. Patients with previous antitumor treatment were excluded. The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) were assessed. Results: A total of 64 patients were enrolled, of which 33 patients received chemotherapy (gemcitabine + cisplatin) in the chemotherapy group, and 31 patients received anti-PD-1antibody (camrelizumab) combined with lenvatinib therapy in the combined therapy group. The median OS was 12.00 months in the combined therapy group and 10.00 months in the chemotherapy group (hazard ratio (HR), 0.57; 95% CI: 0.32-1.03; p < 0.05). The median PFS was 9.00 months in the combined therapy group and 6.00 months in the chemotherapy group (HR, 0.46; 95% CI: 0.25-0.84; p < 0.01). The ORR was 54.84% and 39.39% in the combined therapy and chemotherapy groups, respectively, and the difference was not significant (p = 0.22). The DCR was 80.65% and 72.72% in the combined therapy and chemotherapy groups, respectively (p = 0.46). One patient successfully underwent radical surgery after 8 months of combined therapy and achieved a pathological complete response. Furthermore, no patients experienced AEs of hematologic toxic effects in the combined therapy group compared with the chemotherapy group, demonstrating the advantage of the combined therapy. Conclusions: Anti-PD-1 antibody combined with lenvatinib may be a potentially effective and tolerable first-line treatment for unresectable stage IV GBC.