ASTRO 2020: Combination Radiotherapy and Durvalumab in Localized Bladder Cancer
Posted: Monday, November 23, 2020
Radiotherapy, when combined with the checkpoint inhibitor durvalumab, may be safe and active in patients with localized urothelial cancer of the bladder who are unfit for surgery or are ineligible for cisplatin. A group of researchers, led by Leonard C. Tuanquin, MD, of Penn State Health Milton S. Hershey Medical Center, Hershey, reported their updated efficacy outcomes for this treatment during the virtual edition of the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 57).
“Phase II study has completed accrual, and longer follow-up with progression-free survival, overall survival, and disease control rate post adjuvant treatment will further our understanding of this regimen’s efficacy in locally advanced bladder cancer,” explained the researchers. “Efficacy was also seen in node-positive patients.”
This single-arm phase Ib to II BTCRC-GU15-023 trial recruited 26 patients with T2–4 N0–2 M0 bladder cancer. The primary endpoints for this study were progression-free survival rate at 1 year and disease control rate; secondary endpoints were complete response post radiotherapy with durvalumab, progression-free survival, and overall survival. Participants were treated with durvalumab plus definitive radiotherapy (36 fractions of 64.8 Gy for 7 weeks), followed by adjuvant durvalumab for 1 year.
Of the 26 patients, 30.8% had node-positive disease, and the majority (n = 19) were men. At data cutoff, 24 patients were evaluable for response. After patients completed the full regimen, the disease control rate was 95.8%; the complete response rate was 70.8%; the progressive disease rate was 4.7%; and partial response and stable disease rates were both 12.5%.
Treatment-related adverse events of grade 3 or higher occurred in 10 patients. Anemia, lipase/amylase, immune nephritis, and fatigue each affected one patient, and six patients experienced lymphopenia.
Disclosure: For full disclosures of the study authors, visit redjournal.org.