MP16-14: A Phase II Trial of Intravesical Gemcitabine and Docetaxel (GEMDOCE) in the Treatment of BCG-Naïve Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Authors: Sunil H. Patel, Andrew T. Gabrielson, Sin Chan, Deborah Schwartz, Connie Collins, Nirmish Singla, Bruce Trock, Trinity J. Bivalacqua, Noah Hahn, and Max R. Kates
Full Abstract: https://doi.org/10.1097/01.JU.0001008640.01272.9d.14
For decades. The mainstay treatment for patients with high risk non muscle invasive bladder cancer has been with intravesical treatment with BC G. However, amidst widespread BC G shortages, it is important that we identify other treatment options with similar efficacy that can be utilized in the BC G naive setting, combination, intravesical gemcitabine and dosel or GEM dosi has demonstrated efficacy as a second line agent for patients with BC G, unresponsive non muscle invasive bladder cancer. In this context, we performed a prospective single arm open label phase two trial for patients with BC G naive high risk non muscle invasive bladder cancer. Intravesical gem doi was given weekly for six weeks as induction therapy followed by monthly maintenance therapy for two years. Among responders, the primary endpoint was three month complete response rate and secondary endpoints included adverse events and 12 month complete response rate between August 2020 August 2022. We enrolled 25 patients with a median follow up of 19.6 months. The pretrial pathologic stages were predominantly high grade T one with or without CIS and multifocal high grade T A. The three month and 12 month complete response rate was 100% and 92% respectively. Two patients with pretrial, high grade T one had high grade T one recurrences at nine months and 12 months, no patients progressed to T two. Disease underwent radical cystectomy or had any radiographic evidence of metastatic disease. Grade one adverse events were common. About 90% of patients including hematuria, urinary frequency, urgency and fatigue and five patients. About 20% of our population experienced a grade three or worse adverse event including hematuria and the UT I when taken together. This single arm phase two trial demonstrates that intravesical gem dosi was well tolerated with promising efficacy for patients with BC G naive high risk non muscle invasive bladder cancer. These results provide further impetus to the bridge trial and actively enrolling prospective phase three trial comparing BC G and gem dosi in a similar patient population.
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