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.