Observational studyInvestigative and clinical urology2026
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.
Observational study in Investigative and clinical urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
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Abstract
purposeTo 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
methodsThis 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.
resultsBaseline 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.
conclusionsIntravesical 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.
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