Intravesical instillations of epirubicin after transurethral resection (TUR) for non-muscle-invasive bladder tumors may be effective as prophylaxis against recurrence, according to investigators.
The researchers, who noted that 40%-80% of non-muscle-invasive bladder tumors recur despite complete resection, randomized 303 patients with Ta and T1 non-muscle-invasive bladder cancer into three groups. Group A patients received two intravesical infusions of epirubicin 20 mg/40 mL saline immediately after TUR and within 24 hours. Group B patients received epirubicin 50 mg/100 mL saline on the same schedule as group A. Group C patients underwent treatment with TUR alone and served as controls.
Of the 303 patients, 79 in group A, 84 in group B, and 77 in group C could be evaluated for recurrence, the researchers stated. Subjects had a median follow-up of 44 months. The median recurrence-free survival was 24 months for group A, 38 months for group B, and 13 months for group C, according to a team led by Takashi Saika, MD, of the Okayama University Graduate School of Medicine in Okayama, Japan. The difference in recurrence-free survival between groups B and C was statistically significant.
About 30% of patients experienced instillation-related adverse reactions, including micturition pain and frequency, the researchers said, adding that these were mild and transient.
Study findings appear in the World Journal of Urology (published online ahead of print).