SUO 2024: Multicenter Experience with First-Line Intravesical Gemcitabine-Docetaxel Versus Bacillus Calmette-Guerin for High-Risk NMIBC

(UroToday.com) The 2024 Society of Urologic Oncology (SUO) annual meeting held in Dallas, between December 3 and December 6, 2024, was host to the Abstract/Posters Session. Dr. Gabrielle Yankelevich discussed their multicenter experience with first-line intravesical gemcitabine-docetaxel versus Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer (NMIBC).

There is a global shortage of BCG due to the growing demand for this product worldwide. As a result, many patients are unable to complete the recommended course of BCG treatment, leading some to switch to alternative agents. Recurrence rates within two years after BCG therapy range from 30-50%.^1,2 Consequently, the use of intravesical chemotherapy for both primary and salvage treatments after BCG failure is increasing. This highlights the ongoing challenges in managing non-muscle invasive bladder cancer amid BCG supply issues. The investigators aimed to determine if Gemcitabine/Docetaxel (Gem/Doce) could be associated with similar oncologic efficacy as BCG as the first-line treatment for high-risk non-muscle invasive bladder cancer (HR-NMIBC).

This was a multi-center, retrospective cohort study analyzing 136 patients with HR-NMIBC treated between August 2020 and August 2023. Patients were included in the study if they required Gem-Doce or BCG induction and had the option for maintenance therapy. Those with a history of upper tract urothelial carcinoma were excluded from the study.

The primary endpoint of the study was high-grade (HG) recurrence free survival assessed during surveillance cystoscopy and urine cytology performed every three months. The oncological efficacy of Gem-Doce vs. BCG was evaluated at 12 and 24 months.

A total of 55 patients received Gem/Doce and 81 patients received BCG. The baseline characteristics were well balanced between both groups; however, patients in the Gem/Doce group were older (73 vs. 71 years) and more likely to have multifocal disease (62% vs. 34%) compared to the BCG group. The rest of the baseline characteristics are shown in the table below:
The median follow-up was 21 months, and during this period, 30 high-grade recurrences were documented: 12 in the Gem/Doce group and 18 in the BCG group. The 24-month recurrence-free survival (RFS) rates were 74% for the Gem/Doce group and 81% for the BCG group. Intravesical Gem-Doce did not show a significant difference in recurrence-free survival compared to BCG (p=0.53), as illustrated in the Kaplan-Meier graphic below: The median follow-up was 21 months, and during this period, 30 high-grade recurrences were documented: 12 in the Gem/Doce group and 18 in the BCG group. The 24-month recurrence-free survival (RFS) rates were 74% for the Gem/Doce group and 81% for the BCG group
Dr. Yankelevich concluded her poster presentation by saying that:

First-line intravesical Gem-Doce for HR-NMIBC demonstrates comparable oncologic efficacy to BCG.
Future studies should focus on assessing the tolerability of Gem-Doce, long-term follow-up regarding adverse events, and evaluating cystectomy-free survival as a key endpoint.

Presented by: Gabrielle Yankelevich, MD, Urology PGY4 at the Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.

Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) Luis Carlos Sarmiento Angulo Foundation via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the 2024 Society of Urologic Oncology (SUO) annual meeting held in Dallas, between the 3^rd and 6^th of December, 2024.

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