SESAUA 2023: Oncologic Outcomes: Intravesical Gemcitabine/docetaxel is a Feasible Alternative for Management of High-risk Non-muscle Invasive Bladder Cancer

(UroToday.com) The 2023 SESAUA annual meeting included a bladder cancer session, featuring a presentation by Emily Roebuck discussing oncologic outcomes of intravesical gemcitabine/docetaxel as an alternative for management of high-risk non-muscle invasive bladder cancer.

There continues to be an international shortage of intravesical Bacillus Calmette-Guérin (BCG), the first-line therapy for high-risk non-muscle invasive bladder cancer. To date, no alternative first-line treatments have been approved. In response to this, Atrium Health Wake Forest Baptist employed sequential intravesical chemotherapy of gemcitabine and docetaxel. At the SESAUA annual meeting, Roebuck and colleagues aimed to define oncologic outcomes in patients receiving intravesical gemcitabine and docetaxel to evaluate the efficacy in management of high-risk non-muscle invasive bladder cancer.

This study was a retrospective cohort study of patients with high-risk non-muscle invasive bladder cancer that received intravesical gemcitabine and docetaxel as first-line or salvage therapy. Variables included prior BCG status, tumor pathology, and recurrence status. BCG-unresponsive was defined per FDA definition of adequate BCG, and the primary outcome was recurrence-free survival. The groups assessed, included (i) BCG-naïve versus BCG-unresponsive patients, (ii) patients with CIS present versus no CIS, and (iii) patients with multifocal versus non-multifocal disease. Kaplan-Meier survival analysis was used to determine recurrence-free survival at 6, 12, and 18-months.

There were 45 patients identified for analysis between 2020 and 2022. Pretreatment pathology was high-grade (HG) Ta (71%), CIS (24%) or HG T1(20%). The patients were either BCG-naïve (67%) or BCG-unresponsive (33%) and a majority had multifocal disease (58%). Progression occurred in three patients (6.7%) and one patient died. Overall recurrence-free survival at 6-, 12-, and 18-month was 81%, 61%, and 55% respectively. 12-month recurrence-free survival was high in the BCG-naïve group at 69% (95% CI 0.52-0.90) compared to BCG-unresponsive group at 54% (95% CI 0.29-1.0, p = 0.97):

Additionally, 12-month was a higher for patients with CIS at 89% (95% CI 0.70-1.0) compared to without CIS at 53% (95% CI 0.34-0.84, p = 0.086):

Lastly, 12-month recurrence-free survival was higher for the non-multifocal group at 74% (95% CI 0.54-1.0) compared to multifocal group at 37% (95% CI 0.16-0.84, p = 0.082).

Emily Roebuck concluded her presentation discussing oncologic outcomes of intravesical gemcitabine/docetaxel as an alternative for management of high-risk non-muscle with the following take-home messages:

• This data suggests that intravesical gemcitabine and docetaxel is a feasible alternative to BCG for patients with high-risk non-muscle invasive bladder cancer in the setting of BCG shortage
• Additional studies are needed to evaluate predictors of response to intravesical gemcitabine and docetaxel based on clinical and pathologic characteristics

Presented by: Emily Roebuck, MD, Wake Forest School of Medicine, Atrium Health Wake Forest Baptist, Winston-Salem, NC

Co-Authors: Justin Refugia, MD², Parth Thakker, MD², Taylor Peak, MD², Celeste Watts, PA², Ronald Davis, MD², Ashok Hemal, MD², Matvey Tsivian, MD²

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2023 Southeastern Section of the American Urological Association (SESAUA) Annual Meeting, Amelia Island, FL, Wed, Mar 15 – Sat, Mar 18, 2023.