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
Friday, May 3, 2024 1:00 PM to 3:00 PM · 2 hr. (US/Central)
221B
Abstract
Information
Full Abstract and Figures
Author Block
Sunil H Patel, Andrew T Gabrielson*, Sin Chan, Deborah Schwartz, Connie Collins, Nirmish Singla, Bruce Trock, Baltimore, MD, Trinity J Bivalacqua, Philadelphia, PA, Noah Hahn, Max R Kates, Baltimore, MD
Introduction
Combination intravesical Gemcitabine and Docetaxel (GemDoce) has demonstrated efficacy as a 2nd line therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In the context of widespread BCG shortages, we performed a Phase 2 prospective trial to assess GemDoce for BCG-naïve NMIBC.
Methods
This study is a prospective single-arm open-label phase II trial for patients with BCG-naïve high risk NMIBC. Intravesical gemcitabine and docetaxel was given weekly for 6 weeks as induction followed by monthly maintenance therapy for 2 years among responders. The primary endpoint was 3-month complete response (CR), and key secondary endpoints included adverse events (AE) and 12-month CR.
Results
A total of 25 patients were enrolled between August 2020-August 2022 with median follow-up of 19.6 months. The pre-trial pathologic stages were: HGT1 with CIS (n = 7), HGT1 without CIS (n = 6), HGTa (n = 9), and CIS alone (n = 3) (Table 1). The 3-month and 12-month CR rate was 100% and 88%, respectively (Figure 1). Two patients with pre-trial HGT1 had HGT1 recurrences at 9 and 12 months. No patients progressed to T2 disease, underwent radical cystectomy, or had any radiographic evidence of progressive disease. Grade 1 AEs were common (23/25 patients) including hematuria, urinary frequency, urgency, and fatigue. Five patients (20%) experienced a Grade 3 AE including hematuria and UTI (Table 2).
Conclusions
In this single-arm phase II trial, GEMDOCE was well-tolerated with promising efficacy for patients with BCG-naïve HR NMIBC.
Source Of Funding
Chad Holliday Research Fund
Author Block
Sunil H Patel, Andrew T Gabrielson*, Sin Chan, Deborah Schwartz, Connie Collins, Nirmish Singla, Bruce Trock, Baltimore, MD, Trinity J Bivalacqua, Philadelphia, PA, Noah Hahn, Max R Kates, Baltimore, MD
Introduction
Combination intravesical Gemcitabine and Docetaxel (GemDoce) has demonstrated efficacy as a 2nd line therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In the context of widespread BCG shortages, we performed a Phase 2 prospective trial to assess GemDoce for BCG-naïve NMIBC.
Methods
This study is a prospective single-arm open-label phase II trial for patients with BCG-naïve high risk NMIBC. Intravesical gemcitabine and docetaxel was given weekly for 6 weeks as induction followed by monthly maintenance therapy for 2 years among responders. The primary endpoint was 3-month complete response (CR), and key secondary endpoints included adverse events (AE) and 12-month CR.
Results
A total of 25 patients were enrolled between August 2020-August 2022 with median follow-up of 19.6 months. The pre-trial pathologic stages were: HGT1 with CIS (n = 7), HGT1 without CIS (n = 6), HGTa (n = 9), and CIS alone (n = 3) (Table 1). The 3-month and 12-month CR rate was 100% and 88%, respectively (Figure 1). Two patients with pre-trial HGT1 had HGT1 recurrences at 9 and 12 months. No patients progressed to T2 disease, underwent radical cystectomy, or had any radiographic evidence of progressive disease. Grade 1 AEs were common (23/25 patients) including hematuria, urinary frequency, urgency, and fatigue. Five patients (20%) experienced a Grade 3 AE including hematuria and UTI (Table 2).
Conclusions
In this single-arm phase II trial, GEMDOCE was well-tolerated with promising efficacy for patients with BCG-naïve HR NMIBC.
Source Of Funding
Chad Holliday Research Fund