Therapeutic efficacy of Gemcitabine/Docetaxel maintenance in patients with non-muscle-invasive bladder cancer receiving initial Bacillus Calmette-Guérin induction.

BACKGROUND

In an era of Bacillus Calmette-Guérin (BCG) shortage, intravesical Gemcitabine/Docetaxel (Gem/Doce) is gaining popularity as an alternative treatment for non-muscle-invasive bladder cancer (NMIBC). We compared the outcomes of patients who received BCG induction+BCG maintenance (BCG-BCG) and BCG induction+Gem/Doce maintenance (BCG-Gem/Doce).

METHODS

NMIBC patients undergoing BCG induction between 2018 and 2023 were included in the study. Patients with no evidence of recurrence after induction were initiated on either maintenance BCG (Southwest Oncology Group protocol) or monthly maintenance Gem/Doce. Propensity matching was performed to address potential selection bias. High-grade and Any-grade recurrence-free-survival (RFS), and progression-free-survival (PFS) were measured using the Kaplan-Meier method.

RESULTS

Of 127 patients who received maintenance therapy after BCG induction, 107 received BCG maintenance, while 20 received Gem/Doce maintenance. Following 1:1 propensity matching, 20 matched patients were identified in each group. The median age following propensity-matching was 72 (IQR = 68-79) and 73 (IQR = 68-80), while the median follow-up was 45.3 mo (IQR = 39.6-61.8) and 20.2 mo (IQR = 9.8-37) for the BCG-BCG and BCG-Gem/Doce groups respectively. For the BCG-BCG and BCG-Gem/Doce groups, the 2-year. High-grade RFS was 69.6% (95% CI = 52-93.2) and 88.2% (95% CI = 74.2-100) (log-rank P = 0.5), and the 2-year. Any-grade RFS was 64.6% (95% CI = 46.6-89.6) and 83.8% (95%CI = 68.6-100) (log-rank P = 0.45), while the 2-year. PFS was 89.7% (95% CI = 77.2-100) and 88.9% (95% CI = 75.5-100) (log-rank P = 0.91) respectively.

CONCLUSIONS

Following BCG induction, Gem/Doce may be used with similar efficacy to BCG for maintenance without compromising RFS. Further studies are necessary to validate these findings, but during BCG shortage, one may consider prioritizing BCG for induction therapy alone and using Gem/Doce for maintenance instead.