Radiation and Avelumab in Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer

Trimodality therapy is a bladder-preserving treatment approach for select patients with muscle-invasive bladder cancer (MIBC), and the addition of a concurrent radiosensitizing chemotherapy to bladder radiation improves outcomes. However, a subset of patients is unwilling or unable to receive concurrent chemotherapy with radiation, and the optimal treatment strategy for these patients is unknown.

We performed a single-arm Phase II investigator-initiated trial of radical dose bladder radiation plus concurrent and adjuvant avelumab in patients with MIBC unable to receive concurrent cisplatin-based chemotherapy. The primary endpoint was clinical complete response (cCR) at 3 months following completion of radiation RESULTS: A total of 14 patients were enrolled, and the median age was 83 years (range 79-95 years). All patients completed radiation, and 11 of 14 (79%) completed all 6 planned avelumab infusions. Median follow-up is 21.7 months. The cCR rate was 64%, and the median overall survival was 30.9 months. Three patients experienced a Grade 3 toxicity; no Grade 4 or 5 toxicities were observed.

In this population of cisplatin-ineligible patients with MIBC, many of whom had advanced age and/or medical comorbidities, the combination of radical dose bladder radiation plus concurrent and adjuvant avelumab appeared to be safe and active.