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JU INSIGHT Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer

By: Ian M. McElree, BS, MS; Ryan L. Steinberg, MD; Alex C. Martin, MD; Jordan Richards, MD; Sarah L. Mott, MS; Paul T. Gellhaus, MD; Kenneth G. Nepple, MD; Michael A. O'Donnell, MD; Vignesh T. Packiam, MD | Posted on: 01 Sep 2022

McElree IM, Steinberg RL, Martin AC, et al. Sequential intravesical gemcitabine and docetaxel for bacillus Calmette-Guérin-naïve high-risk nonmuscle-invasive bladder cancer. J Urol. 2022;(3)589-599.

Study Need and Importance

High-risk nonmuscle-invasive bladder cancer (NMIBC) poses significant risk of recurrence and progression. Bacillus Calmette-Guérin (BCG) is currently recommended as the gold standard adjuvant therapy following complete transurethral resection of bladder tumor. Continued production issues have precluded use of BCG in many urological practices. Furthermore, the efficacy and tolerance of BCG is suboptimal. Given these factors, there has been increasing interest and utilization of alternative first-line intravesical therapies. Given ongoing BCG shortages, our institution has transitioned to use of sequential intravesical gemcitabine and docetaxel (Gem/Doce) in the first-line setting.

“Continued production issues have precluded use of BCG in many urological practices. Furthermore, the efficacy and tolerance of BCG is suboptimal.”

What We Found

We analyzed a cohort of 107 patients with high-risk BCG-naïve NMIBC treated with Gem/Doce. Patients had high-risk characteristics including 47 with any carcinoma in situ and 55 with T1 disease. Median followup was 15 months. Recurrence-free survival was 89%, 85% and 82% at 6, 12 and 24 months, respectively (see Figure). The recurrence rates were not affected when the cohort was stratified by presence of carcinoma in situ. No patients developed disease progression or died of bladder cancer. One patient underwent cystectomy for end-stage lower urinary tract symptoms. Overall survival was 84% at 2 years. The treatment was well tolerated, with only 4 patients unable to tolerate a full induction course of Gem/Doce. The most commonly reported side effect was frequency/urgency occurring during instillation.

Figure. Recurrence-free survival following Gem/Doce induction.

“Compared to BCG, this treatment is readily available, cheap and not subject to supply constraints.”

Limitations

This study is limited by its retrospective nature and lack of a comparator arm, allowing for potential selection bias. Furthermore, these results are from a high-volume institution with rigorous NMIBC protocols that may limit generalizability.

Interpretation for Patient Care

Our results demonstrate that Gem/Doce is a safe and effective adjuvant treatment for patients with high-risk NMIBC. Compared to BCG, this treatment is readily available, cheap and not subject to supply constraints. While prospective validation is needed, in the setting of chronic BCG shortage, Gem/Doce represents a valuable alternative treatment option for patients with NMIBC.