Intravesical instillation of gemcitabine immediately following resection of suspected low-grade non-muscle-invasive bladder tumors may decrease the risk of disease recurrence, according to a new study.

In a randomized double-blind trial that enrolled 406 patients at 23 US centers, this approach was associated with a significant 34% reduction in recurrence risk compared with saline instillation, Edward M. Messing, MD, of the University of Rochester, Strong Memorial Hospital, in Rochester, New York, and colleagues reported in the Journal of the American Medical Association (2018;319:1880-1888). Of the 215 patients who receive instillations and were found to have low-grade non-muscle-invasive bladder cancer—the study protocol’s pre-specified target population—gemcitabine-treated patients had a significant 47% decreased risk of recurrence.

In the overall study population, 35% of 201 gemcitabine-treated patients had recurrence compared with 47% of 205 who received saline over a median 4 years of follow-up. In the study protocol’s pre-specified target population, 34% of 102 gemcitabine-treated patients vs 54% of 113 patients who received saline had recurrence.

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The investigators concluded that their findings support using the gemcitabine instillation therapy, but further research is needed to compare gemcitabine with other intravesical agents.

“To our knowledge, this phase 3 trial is the first to demonstrate a significant benefit for a single postoperative instillation of a new agent in more than 2 decades,” the authors wrote.

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For the study, investigators randomly assigned 201 patients to receive instillation of gemcitabine (2 g in 100 mL of saline) and 205 to receive instillation of 100 mL of saline for 1 hour immediately after transurethral resection of bladder tumor. Of the 406 randomized patients, 383 completed the trial.


Messing EM, Tangen CM, Lerner SP, et al. Effect of intravesical instillation of gemcitabine vs saline immediately following resection of suspected low-grade non-muscle-invasive bladder cancer on tumor recurrence. JAMA. 2018;319:1880-1888.