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

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

doi:10.1016/j.euo.2024.12.005

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

Eur Urol Oncol. 2024 Dec 17:S2588-9311(24)00288-8. doi: 10.1016/j.euo.2024.12.005. Online ahead of print.

Authors

Jacob Taylor¹, Ashish M Kamat², Drupad Annapureddy¹, Zine-Eddine Khene¹, Jeffrey Howard¹, Wei Shen Tan², Ian M McElree³, Davaro Facundo⁴, Kendrick Yim⁵, Stephen Harrington⁶, Elizabeth Dyer⁶, Anna J Black⁷, Pratik Kanabur⁸, Mathieu Roumiguié⁹, Seth Lerner⁸, Peter C Black⁷, Jay Raman⁶, Mark Preston⁵, Gary Steinberg¹⁰, William Huang¹¹, Roger Li⁴, Vignesh T Packiam³, Solomon L Woldu¹, Yair Lotan¹², Michael A O'Donnell³

Affiliations

¹ University of Texas Southwestern Medical Center, Dallas, TX, USA.
² UT MD Anderson Cancer Center, Houston, TX, USA.
³ University of Iowa, Iowa City, IA, USA.
⁴ Moffit Cancer Center, Tampa, FL, USA.
⁵ Brigham and Women's Hospital, Boston, MA, USA.
⁶ Penn State University, Hershey, PA, USA.
⁷ University of British Columbia, Vancouver, BC, Canada.
⁸ Baylor College of Medicine, Houston, TX, USA.
⁹ CHU-Institut Universitaire du Cancer-Oncopôle, Toulouse, France.
¹⁰ Rush University, Chicago, IL, USA.
¹¹ New York University Langone Health, New York, NY, USA.
¹² University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: yair.lotan@utsouthwestern.edu.

PMID: 39694798
DOI: 10.1016/j.euo.2024.12.005

Abstract

Background and objective: 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.

Methods: 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.

Key findings and limitations: 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.

Conclusions and clinical implications: 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.

Patient summary: 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.

Keywords: Bladder-sparing therapy; Docetaxel; Gemcitabine; Intravesical therapy; Urinary bladder neoplasms.