AUA 2022: Long-term Follow-up of Intravesical Gemcitabine and Docetaxel as Rescue Therapy for NMIBC

(UroToday.com) The 2022 American Urological Association (AUA) Annual Meeting included a session on the epidemiology and evaluation of bladder cancer and a presentation by Dr. Michael O’Donnell discussing long-term follow-up of intravesical gemcitabine and docetaxel as rescue therapy for non-muscle invasive bladder cancer (NMIBC). While radical cystectomy remains the preferred treatment for bacillus Calmette-Guérin (BCG) unresponsive high-risk NMIBC, many patients are either unwilling or unfit to undergo surgery. Previous retrospective studies have demonstrated the efficacy of intravesical gemcitabine and docetaxel for treating NMIBC after BCG failure but only reported moderate-length follow-up. This study described the long-term outcomes of patients treated with intravesical gemcitabine and docetaxel after BCG failure.

 

 This study retrospectively identified patients at a single institution treated with gemcitabine and docetaxel for high-risk NMIBC after BCG failure between 2009 and 2017. Patients received six weekly intravesical gemcitabine and docetaxel instillations, and monthly maintenance for 2 years was initiated if disease free at first follow-up. Surveillance was performed according to American Urological Association guidelines. Outcomes included high-grade recurrence-free survival (HG-RFS), progression-free survival, cystectomy-free survival, cancer-specific survival and overall survival. Recurrence was defined as pathologically confirmed tumor relapse in the bladder or prostatic urethra, and progression was defined as recurrence of disease with stage T2 or greater, cystectomy or death due to bladder cancer. Survival probabilities were calculated with the Kaplan-Meier method, indexed from the first gemcitabine and docetaxel instillation.

 There was a total of 97 patients with a median age of 73 years and median follow-up of 49 months (IQR 29 – 62) that were treated with gemcitabine and docetaxel after BCG failure. BCG-unresponsive disease comprised 35% of the cohort and BCG-relapsing disease comprised 38%; patients with carcinoma in-situ comprised 71% of the cohort. Complete response at initial 3-month surveillance was 74% and median duration of response was 26 months. During follow-up, 18 patients (19%) underwent radical cystectomy and 28 patients (29%) experienced disease progression. The survival outcomes stratified by 1, 2 and 5 years are as follows:

 

AUA22_O’Donnell 

 

Dr. O’Donnell concluded this presentation discussing long-term follow-up of intravesical gemcitabine and docetaxel as rescue therapy for NMIBC with the following take-home messages:

  • Intravesical gemcitabine and docetaxel for high-risk NMIBC after BCG failure offers long-term efficacy with substantial likelihood of bladder preservation at five years after induction while maintaining excellent cancer-specific survival
  • Future prospective trials assessing gemcitabine and docetaxel are warranted

 

Presented by: Michael A. O’Donnell, MD, Department of Urology, Iowa City, IA
Co-Authors: Ian M. McElree, Alexander C. Martin, Jordan R. Richards, Sarah L. Mott, Paul T. Gellhaus, Kenneth G. Nepple, Ryan L. Steinberg, Vignesh T. Packiam, Iowa City, IA

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 2022 American Urological Association (AUA) Annual Meeting, New Orleans, LA, Fri, May 13 – Mon, May 16, 2022.