Intravesical gemcitabine cuts risk for bladder cancer recurrence

  • Messing EM & et al.
  • JAMA
  • 8 May 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Lack of information on tumor size.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit