Multi-Institution Evaluation of Sequential Gemcitabine and Docetaxel as Rescue Therapy of Non-muscle Invasive Bladder Cancer.

Rescue intravesical therapies for BCG failure non-muscle invasive bladder cancer (NMIBC) patients remain a critical focus of ongoing research. Sequential intravesical gemcitabine and docetaxel (Gem/Doce) has shown safety and efficacy in 2 retrospective, single institution cohorts. This doublet has since been adopted as an intravesical salvage option at multiple institutions. We now report the results of a multi-institutional evaluation of Gem/Doce.

Each institution retrospectively reviewed all patients treated with intravesical Gem/Doce for NMIBC between June 2009 and May 2018. Only patients with recurrent NMIBC and a history of prior BCG treatment were included in the analysis. If disease-free after induction, maintenance was instituted at the treating physician's discretion. Post-treatment surveillance followed AUA guidelines. Survival analysis was performed using the Kaplan Meier method and risk factors for treatment failure assessed with Cox regression models.

Two hundred seventy-six patients (median age 73 years with 22.9 months median follow-up) received treatment. Nine patients were unable to tolerate a full induction course. One and two-year recurrence-free survival (RFS) were 60% and 46% and high grade RFS were 65% and 52%, respectively. Ten patients (10/276, 3.6%) had disease progression on TUR. Forty-three (43/276, 15.6%) patients went on to cystectomy (median 11.3 months from induction), of which 11 (11/276, 4.0%) had progressed to muscle-invasion. Analysis identified no patient, disease, or prior treatment-related factors associated with Gem/Doce failure.

Intravesical Gem/Doce is well-tolerated and effective, providing a durable response in NMIBC patients with recurrence after BCG. Further prospective study is warranted.

The Journal of urology. 2019 Dec 10 [Epub ahead of print]

Ryan L Steinberg, Lewis J Thomas, Nathan Brooks, Sarah L Mott, Andrew Vitale, Trafford Crump, Mounica A Rao, Marcus J Daniels, Jonathan Wang, Supriya Nagaraju, William C DeWolf, Donald L Lamm, Max Kates, Matthew E Hyndman, Ashish M Kamat, Trinity J Bivalacqua, Kenneth G Nepple, Michael A O'Donnell

University of Texas Southwestern, Department of Urology, Dallas, Texas., Cleveland Clinic Foundation, Department of Urology, Cleveland, Ohio., MD Anderson Cancer Center, Houston, Texas., Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa., University of Iowa, Department of Urology, Iowa City, Iowa., University of Calgary, Department of Urology, Calgary, ON, Canada., University of Arizona School of Medicine, Phoenix, Arizona., Johns Hopkins University, Department of Urology, Baltimore, Maryland., Beth Israel Deaconess Medical Center, Boston, Massachusetts.

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