Introduction:

The combination of  gemcitabine and docetaxel (Gem/Doce) as intravesical chemotherapy has been considered as a possible alternative to BCG installations when treating patients with non-muscle invasive bladder cancer (NIMBC), the Gem/Doce combination gained popularity in 2021 due to worldwide BCG shortage. Lately, several research articles assessed the efficacy of this therapy in different settings.  We seek to determine the efficacy of the treatment in patients with low and intermediate risk disease using 2 different protocols using Gem/Doce induction only versus  Gem/Doce induction with maintenance.

Methods:

Our single institution prospectively maintained database identified consecutive patients who were diagnosed with NIMBC during 2020-2023, included were low risk and intermediate BCG naïve patients with non-muscle invasive bladder cancer who received Gem/Doce induction and maintenance courses. Patients were stratified according to the treatment protocol. Bladder cancer risk-group stratification was performed using AUA guidelines 2016. Baseline characteristics, pathology, cystoscopy, and cytology reports were collected from electronic medical charts. Study findings were reported using descriptive statistics. Kaplan-Mayer survival analysis was performed to detect Recurrence-free survival (RFS). A p-value of <0.05 was considered statistically significant. R programming language version 4.3 was used for all statistical analyses.

Results:

A total of 49 patients were included in the study, the median age was 74 (IQR 64-78).  Thirteen patients (27%) were females. The median follow-up time was 9 months (IQR 4-15), risk-group stratification yielded 5 patients with low-risk disease (10%) and 44 patients with Intermediate-risk disease (90%). Four patients (8%) had prior BCG exposure more than 2 years before initiation of treatment. Overall, 21 patients (43%) had recurrences at any point. One patient at the induction with maintenance arm developed a metastatic disease and died as a consequence. RFS at 3, 6, and 12 months for the Gem/Doce induction only was 97%,70%, and 51% and for Gem/Doce induction + maintenance 100%, 94%, and 94%. Gem/Doce Induction with maintenance arm had better RFS at median follow-up time than induction only arm (Figure 1.). Baseline characteristics stratified according to treatment arm are presented in Table 1. 

Conclusion:

The use of Gem/Doce induction with maintenance resulted in superior recurrence free survival than induction only in patients with low and intermediate risk non-muscle invasive bladder cancer. However, further prospective trials with bigger cohorts and longer follow-up time are necessary to validate our results.  

Funding: N/A