Intravesical gemcitabine versus Bacillus Calmette-Guérin (BCG) for intermediate-/high-risk non-muscle-invasive bladder cancer during the BCG shortage: Safety, efficacy, and health-economic context.

PURPOSE: To evaluate the safety, toxicity, efficacy, and health-economic context of intravesical gemcitabine (GEM) in patients with non-muscle-invasive bladder cancer (NMIBC), and compare outcomes with Bacillus Calmette-Guérin (Onco-BCG; Cipla Ltd.), particularly during shortages.

MATERIALS AND

METHODS

This prospective observational study included 128 patients with intermediate- or high-risk NMIBC. Sixty-six received intravesical GEM after transurethral resection of bladder tumor (TURBT), while 62 received Onco-BCG. GEM was administered according to the GUBGEM protocol. Safety was assessed through clinical, laboratory, I-PSS (International Prostate Symptom Score), and CTCAE (Common Terminology Criteria for Adverse Events) v5.0 grading. Efficacy was evaluated by recurrence-free survival (RFS), progression rates, and Kaplan-Meier analysis.

RESULTS

Baseline demographic and pathological characteristics were similar. GEM demonstrated a favorable safety profile, with 90.9% experiencing none or grade 1 adverse events. Urinary tract infection (20.0%), dysuria (17.3%), and musculoskeletal pain (10.8%) were the most common symptoms. No severe systemic toxicities were observed. Recurrence occurred in 34.8% of GEM patients versus 16.1% with Onco-BCG (p=0.016). Median RFS was 32 months for GEM and 60 for Onco-BCG. Log-rank analysis showed significantly lower RFS with GEM (p=0.017), confirmed by Cox regression (hazard ratio 2.92, 95% confidence interval 1.30-6.54; p=0.009). Most recurrences occurred within the first 12 months.

CONCLUSIONS

Intravesical GEM was safe, well tolerated, and associated with high adherence. Although recurrence prevention was inferior to Onco-BCG-particularly within the first 12 months, with no difference in progression-GEM represents a pragmatic, budget-sensitive alternative during Onco-BCG shortages or intolerance.