Response to First-Line Chemotherapy Predicts Response to Maintenance Avelumab Therapy in Japanese Patients With Advanced Urothelial Carcinoma.

OBJECTIVES

The association between the response to first-line chemotherapy and maintenance of avelumab remains unclear. We identified factors associated with the response to avelumab in patients with advanced urothelial carcinoma using real-world data.

METHODS

We retrospectively enrolled 100 patients with advanced urothelial carcinoma treated with maintenance avelumab therapy between March 2021 and April 2024 at Nagoya University and nine affiliated hospitals. The complete/partial-response group was defined as patients with complete response or partial response as the best response to first-line chemotherapy. The stable disease group was defined as patients with stable disease as the best response to first-line chemotherapy.

RESULTS

Seven patients (7.0%) achieved complete response, 65 (65.0%) achieved partial response, and 28 (28.0%) achieved stable disease as the best response to first-line chemotherapy. Regarding avelumab therapy, the complete/partial-response group had significantly better progression-free survival than the stable disease group (median: 11.1 vs. 3.2 months, p < 0.001). In multivariate analyses, the best response to first-line chemotherapy was the only independent risk factor for progression-free survival (hazard ratio = 1.844, 95% confidence interval = 1.002-3.394; p = 0.049). Overall survival was significantly shorter in the stable disease group than in the complete/partial-response group (median: 14.1 months vs. not reached, p < 0.001). Multivariate analyses revealed significant associations between poor overall survival and performance status (hazard ratio = 2.175, 95% confidence interval = 1.030-4.592; p = 0.042) and the best response to first-line chemotherapy (hazard ratio = 4.174, 95% confidence interval = 1.975-8.824; p < 0.001).

CONCLUSIONS

The best response to first-line chemotherapy may predict the clinical outcome of patients with advanced urothelial carcinoma treated with avelumab.