Oncologic Outcomes of Sequential Intravesical Gemcitabine and Docetaxel Compared with Bacillus Calmette-Guérin in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle Invasive Bladder Cancer.

Non-muscle-invasive bladder cancer (NMIBC) patients treated with additional bacillus Calmette-Guérin (BCG) may become unresponsive to BCG. Recently, sequential intravesical gemcitabine and docetaxel (gem/doce) are being used for NMIBC. This study aims to compare oncologic outcomes between sequential intravesical gem/doce versus additional BCG in patients with BCG-unresponsive NMIBC.

Data were collected from ten academic institutions on patients with BCG-unresponsive NMIBC based on the Food and Drug Administration guidelines. Information on high-grade recurrence-free (HGRFS), progression-free (PFS), cystectomy-free (CFS), metastasis-free (MFS), cancer-specific (CSS), and overall (OS) survival was collected. The Kaplan-Meier method and Cox proportional hazard ratios (HRs) were used to determine differences in oncologic outcomes between the Gem/Doce and BCG groups.

Of 299 total patients, 204 underwent additional BCG treatment at the time of BCG unresponsiveness and 95 underwent gem/doce treatment. Rates of PFS (HR 2.6, 95% confidence interval [CI] 1.1-5.0, p = 0.03), CFS (HR 2.0, 95% CI 1.2-3.4, p = 0.01), and CSS (HR 3.7, 95% CI 1.1-12.3, p=0.03) were higher in patients receiving gem/doce. HGRFS, MFS, and OS were similar between both groups.

The findings from this study suggest that intravesical gem/doce is associated with lower rates of progression than additional BCG in patients with BCG-unresponsive NMIBC who decline or are ineligible for cystectomy.

In this report, we looked at outcomes between patients with noninvasive bladder cancer who were treated with additional bacillus Calmette-Guérin (BCG) or gemcitabine-docetaxel combination after not responding to primary BCG therapy. We found that intravesical gemcitabine-docetaxel was associated with fewer progression events than additional salvage BCG therapy.

European urology oncology. 2024 Dec 17 [Epub ahead of print]

Jacob Taylor, Ashish M Kamat, Drupad Annapureddy, Zine-Eddine Khene, Jeffrey Howard, Wei Shen Tan, Ian M McElree, Davaro Facundo, Kendrick Yim, Stephen Harrington, Elizabeth Dyer, Anna J Black, Pratik Kanabur, Mathieu Roumiguié, Seth Lerner, Peter C Black, Jay Raman, Mark Preston, Gary Steinberg, William Huang, Roger Li, Vignesh T Packiam, Solomon L Woldu, Yair Lotan, Michael A O'Donnell

University of Texas Southwestern Medical Center, Dallas, TX, USA., UT MD Anderson Cancer Center, Houston, TX, USA., University of Iowa, Iowa City, IA, USA., Moffit Cancer Center, Tampa, FL, USA., Brigham and Women's Hospital, Boston, MA, USA., Penn State University, Hershey, PA, USA., University of British Columbia, Vancouver, BC, Canada., Baylor College of Medicine, Houston, TX, USA., CHU-Institut Universitaire du Cancer-Oncopôle, Toulouse, France., Rush University, Chicago, IL, USA., New York University Langone Health, New York, NY, USA., University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: .