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Trimodality Therapy With or Without Adjuvant Durvalumab in Muscle-Invasive Bladder Cancer

By: Jenna Carter, PhD
Posted: Tuesday, July 19, 2022

Targeted immunotherapy has been shown to improve outcomes in patients with muscle-invasive bladder cancer, in both the advanced as well as adjuvant settings after cystectomy. In an ongoing study presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS4619), researchers discussed how trimodality treatment—consisting of transurethral resection of bladder tumor followed by chemoradiotherapy—may be considered an alternative to radical cystectomy in patients with muscle-invasive bladder cancer. Wassim Kassouf, MD, of McGill University Health Center, Montreal, and colleagues hypothesized that the PD-L1 inhibitor durvalumab might improve outcomes in patients when administered in the adjuvant setting after completion of trimodality therapy.

This randomized phase II study is part of the Canadian Cancer Trials Group and consists of patients with stage T2–T4a N0M0 urothelial carcinoma treated with trimodality therapy. Treatment arms consist of durvalumab at 1,500 mg intravenously every 4 weeks for 12 months versus surveillance. The primary objective is to compare disease-free survival between arms, and the secondary endpoints include a non–muscle-invasive bladder cancer recurrence rate (< T2), overall survival, bladder-intact disease-free survival, and metastasis-free survival, among others.

A pilot substudy (BL13F) has been initiated and will evaluate the feasibility of electronic real-time patient self-reporting of immunotherapy-related adverse events. The reports will be collected using a SYMPTOM-IQ Tool on the uMotif Mobile Health Application. A sample size of 190 including a 5% dropout rate is needed, assuming a 2-year disease-free survival rate of 65% for patients on the control arm and an estimated 12% improvement in the 2-year rate (65%–77%, hazard ratio = .61) with 80% power using a one-sided 10% level test. The study was activated in December 2018, and as of January 2022, 49 patients have been enrolled.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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