Efficacy and safety of RC48 in combination with PD-1 inhibitors for the treatment of locally advanced or metastatic urothelial carcinoma: a single-center, real-world study.

OBJECTIVE

This study aims to assess the efficacy and safety of RC48 in combination with PD-1 inhibitors for patients diagnosed with locally advanced or metastatic urothelial carcinoma (mUC).

METHODS

A retrospective analysis was performed on clinical data from 53 patients with locally advanced or metastatic bladder cancer, who were treated at the First Affiliated Hospital of Bengbu Medical College between January 2023 and December 2023. The cohort was stratified into two groups: the RC48 combined immunotherapy group (RC48 + PD-1, n = 27) and the conventional chemotherapy group (gemcitabine and cisplatin regimen, GP, n = 26).

RESULTS

The RC48 + PD-1 group demonstrated significantly higher objective response rates (ORR) and median progression-free survival (PFS) compared to the chemotherapy group (P < 0.05). Notably, the incidence of grade 3 or higher adverse events was elevated in the chemotherapy cohort, predominantly due to hematologic toxicities, with no treatment-related fatalities reported. In contrast, the RC48 combined PD-1 group primarily experienced immune-related adverse events, without any incidents of grade 3 or higher adverse effects or treatment-related deaths.

CONCLUSION

The combination of RC48 and PD-1 inhibitors exhibits promising antitumor activity and a manageable safety profile in patients with locally advanced or metastatic UC.