- Immediate postoperative instillation of gemcitabine was well tolerated and reduced risk for recurrence in patients with low-grade non-muscle-invasive urothelial cancer (NMIUC).
Why this matters
- Gemcitabine is a readily available and cost-effective drug.
- Guidelines call for a single postoperative instillation of intravesical chemotherapy.
- Multicenter, randomized double-blind SWOG S0337 trial of 406 patients with suspected low-grade NMIUC, randomly assigned to receive intravesical instillation of gemcitabine or saline for 1 hour immediately after transurethral resection of bladder tumor (TURBT).
- Funding: National Cancer Institute of the National Institutes of Health.
- 35% of patients in the gemcitabine group and 47% in the saline group had recurrence during the median follow-up of 4 years (HR, 0.66; Pone-sided<.001>
- In patients with low-grade NMIUC who underwent TURBT (n=215), 34% vs 54% had recurrence, respectively (HR, 0.53; Pone-sided=.001).
- In the gemcitabine vs saline group:
- 5 vs 10 patients had progression to muscle-invasive urothelial cancer (Pone-sided=.11);
- 17 vs 25 patients died of any cause (Pone-sided=.12).
- No significant differences in grade 3 adverse events (2.4% vs 3.4%; Pone-sided=.29) and no grade ≥4 toxicity was observed.
- Lack of information on tumor size.