The efficacy and safety of chemotherapy with or without anti-PD-1 for the first-line treatment of advanced urothelial carcinoma.

OBJECTIVE: To compare the efficacy and safety of first-line anti-PD-1 combined with chemotherapy versus chemotherapy alone in patients with advanced urothelial carcinoma (UC). METHOD: Patients with advanced UC who received first-line treatment of chemotherapy (n = 51, gemcitabine/paclitaxel [albumin-bound] combined with platinum) or immunochemotherapy (n = 50, PD-1 inhibitors plus chemotherapy) were enrolled. The efficacy and safety were analyzed between the two groups. RESULTS: This study included data from 101 patients, including 51 patients in the chemotherapy group and 50 patients in the immunochemotherapy group. The median progression-free survival of the immunochemotherapy group was significantly longer than that of the chemotherapy group (11.5 vs. 7.17 m, HR = 0.56, p = 0.009). The two groups' overall survival showed no significant difference (20.3 vs. 17.8 m, p = 0.204). The objective response rates and the disease control rates of the two groups were 38.0% versus 49.0% (p = 0.26) and 88.0% versus 80.4% (p = 0.29). The incidence of adverse reactions (AEs) in the immunochemotherapy group and chemotherapy group were 90.0% and 84.3% (p = 0.394), respectively, and the incidence of Grade III-IV AEs were 32.0% and 35.3% (p = 0.726), respectively. CONCLUSION: In the first-line treatment of patients with advanced UC, anti-PD-1 therapy combined with chemotherapy might have better efficacy than chemotherapy alone, and AEs are similar between the two groups.