A Phase II Trial of Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN BLADDER)
Daniel M. Geynisman, Philip Abbosh, Matthew Zibelman, Rebecca Feldman, Eric Ross, David J. McConkey, Noah M. Hahn, Jean H. Hoffman-Censits, Trinity Bivalacqua, Edouard J. Trabulsi, Costas D. Lallas, Rosalia Viterbo, Eric M. Horwitz, Thomas M. Churilla, R. Katherine Alpaugh, Richard E. Greenberg, Marc C. Smaldone, Robert Uzzo, David Chen, Alexander Kutikov, Elizabeth R. Plimack
Cisplatin-based neoadjuvant chemotherapy followed by cystectomy or chemoradiation is the standard of care for urothelial carcinoma patients with muscle invasive bladder cancer.
Both cystectomy and chemoradiation carry potential short and long-term toxicity and quality of life implications.
Recent work has shown that mutations in DNA damage repair/response genes are predictive of pathologic response to neoadjuvant chemotherapy at the time of cystectomy, with those patients achieving pT0 disease demonstrating excellent long-term survival.1-4
Sparing patients cystectomy or chemoradiation after neoadjuvant chemotherapy without compromising oncologic outcomes would improve quality of life and decrease morbidity.
Primary Aim: To evaluate a risk-adapted approach to the treatment of muscle invasive bladder cancer.
Primary Objective: To evaluate the metastasis-free survival at 2 years for all patients
Key Secondary Objectives:
To assess the rate of any urothelial carcinoma recurrence in active surveillance patients
To assess bladder preservation rates with neoadjuvant AMVAC and subsequent risk-adapted treatment
To assess the feasibility of an Endoscopic Tumor Quantification System
To assess quality of life with neoadjuvant AMVAC and subsequent risk-adapted treatment (EORTC QLQ-BLM 30, SHIM, FSFI, AUA symptoms score)
To assess genomic correlates and mutations in urinary cellfree DNA.