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.
Clinical genitourinary cancer. 2026 Mar 17 [Epub ahead of print]
Kent W Mouw, Kee-Young Shin, James Parisi, Bingxue Zhai, Beverly Spicer, Eileen Mann, Ooviya Sathiyamoorthy, Matt Mossanen, Praful Ravi, Arvind Ravi, Brad McGregor, Guru Sonpavde, Daniel Fein, Stephanie Berg, Charlene Mantia, Mark Preston, Ali Baghian, Joaquim Bellmunt
Department of Radiation Oncology, Dana-Farber Cancer Institute, Mass General Brigham, Boston, MA. Electronic address: ., Department of Radiation Oncology, Dana-Farber Cancer Institute, Mass General Brigham, Boston, MA., Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA., Department of Urology, Mass General Brigham, Boston, MA., Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., AdventHealth Cancer Institute University of Central Florida, Orlando, FL.