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

Area of Science:

• Oncology
• Radiation Oncology
• Clinical Trials

Background:

• Trimodality therapy (bladder radiation + chemotherapy) improves outcomes for muscle-invasive bladder cancer (MIBC).
• Some MIBC patients cannot tolerate concurrent chemotherapy with radiation.
• Optimal treatment for cisplatin-ineligible MIBC patients remains unclear.

Purpose of the Study:

• To evaluate the safety and efficacy of radical dose bladder radiation with concurrent and adjuvant avelumab.
• To assess clinical complete response (cCR) rates in MIBC patients unable to receive cisplatin-based chemotherapy.

Main Methods:

• Phase II, single-arm, investigator-initiated trial.
• 14 patients with MIBC received radical dose bladder radiation plus concurrent and adjuvant avelumab.
• Primary endpoint: cCR at 3 months post-radiation.

Main Results:

• Median patient age was 83 years; 14 patients enrolled.
• 64% cCR rate observed.
• Median overall survival of 30.9 months; Grade 3 toxicity in 3 patients, no higher-grade toxicities.

Conclusions:

• Radical dose bladder radiation with concurrent and adjuvant avelumab is a safe and active option.
• This approach benefits cisplatin-ineligible MIBC patients, including the elderly and those with comorbidities.
• Further investigation is warranted for this patient subset.