Platinum-based chemotherapy is the standard and first-line treatment for advanced or metastatic urothelial carcinoma. However, the overall outcomes of the therapy remain to be controversial. This study aims to evaluate the efficacy of avelumab maintenance therapy in patients with urothelial carcinoma.
This phase 3 trial included a total of 700 patients with unresectable totally advanced or metastatic urothelial cancer. The patients who did not have disease progression after first-line therapy were included. The patients were randomly assigned to receive the best supportive care with or without maintenance avelumab. The primary outcome of the study was overall survival.
The addition of avelumab to supportive care was associated with a significant prolongation of overall survival when compared with supportive care alone. The overall survival after 1 year was 71.3% in the avelumab maintenance group and 58.4% in the best supportive care only group. The findings also suggested that the overall median survival was 21.4 months in the avelumab maintenance group and 14.3% in the best supportive care only group. The median progression-free survival was also longer in the avelumab group (3.7 months) compared with the care only group (2 months)
The research concluded that the inclusion of avelumab maintenance therapy to supportive care was associated with prolonged survival in patients with urothelial carcinoma.