(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to a non-invasive bladder cancer moderated poster session. Ian McElree presented his group’s work evaluating sequential intravesical gemcitabine and docetaxel for both treatment-naive and previously treated intermediate-risk non-muscle invasive bladder cancer patients.
Current guidelines recommend adjuvant intravesical therapy for patients with intermediate-risk NMIBC. While intravesical gemcitabine-docetaxel (Gem/Doce) has demonstrated favorable outcomes for high-risk NMIBC and is an increasingly utilized approach in this setting, particularly in the BCG-unresponsive disease state, its efficacy/safety has yet to be fully evaluated for patients with intermediate-risk disease. As such, the objective of this study was to evaluate the efficacy and adverse events profile of Gem/Doce in the adjuvant setting for patients with intermediate-risk NMIBC.
This was a retrospective, single center study of all patients with intermediate-risk NMIBC, as per the AUA definition, treated with intravesical Gem/Doce between March 2012 and July 2022. All patients received sequential intravesical instillations of 1 g gemcitabine and 37.5 mg docetaxel for 6 weeks (induction course). The maintenance regimen consisted of monthly instillations for 2 years if there was no evidence of disease recurrence. The primary outcome was recurrence-free survival (RFS), defined as the time from the start of intravesical Gem/Doce until evidence of disease recurrence. Survival analysis utilizing Kaplan-Meier curves was employed, with between-group comparisons performed using the log-rank test. All patients underwent surveillance in accordance with the AUA guidelines.
The study included 77 patients, with a median follow-up of 26 months (IQR: 14 to 50). While all patients had intermediate-risk NMIBC at time of treatment, the initial disease presentation was as follows:
- LG Ta: 87%
- Isolated HG Ta <3 cm: 4%
- LG Ta + focal HG Ta: 7%
- LG T1: 3%
Prior to Gem/Doce induction, 43% of patients had received prior intravesical therapy, with a median number of prior induction courses of 1 (IQR: 1 to 2). 23, 13, and 13 patients had received at least one previous induction course of BCG, single-agent docetaxel, and mitomycin, respectively.
In the overall cohort, the 2-year RFS was 71%. RFS outcomes were superior in patients who were treatment-naïve (p=0.04), compared to those with prior intravesical induction courses, with 2-year RFS estimates of 79% and 64%, respectively.
Three patients had an HG recurrence during follow-up. Three (4%) patients did not tolerate a full induction course. An adverse event occurred in 38% of patients – all of which were grade 1-2 except for one which was Grade 3 (acute oxygen desaturation). The most frequent adverse events were:
- Urinary urgency/frequency (10%)
- Bladder spasms (9%)
- UTI (5%)
The authors concluded that Gem/Doce was an effective and well-tolerated adjuvant therapy in a heterogeneous population of patients with intermediate-risk NMIBC. Based on these results, further prospective evaluation is needed.
Presented by: Ian McElree, Medical Student, University of Iowa, Iowa City, IA
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023