(HealthDay News) — Locoregional control of muscle-invasive bladder cancer is significantly improved with a treatment regimen consisting of radiotherapy and concurrent chemotherapy with mitomycin C and fluorouracil, according to a phase 3 study published in the April 19 issue of the New England Journal of Medicine.
Nicholas D. James, M.B., B.S., Ph.D., of the University of Birmingham in the United Kingdom, and colleagues conducted a multicenter trial involving 360 patients with muscle-invasive bladder cancer. Patients were randomized to receive radiotherapy with or without synchronous chemotherapy with mitomycin C and fluorouracil. Locoregional disease-free survival was the primary end point, and overall survival and toxicity were secondary end points.
At two years of follow-up, the researchers found that locoregional disease-free survival was 67 percent in the group which received chemotherapy and radiation, compared with 54 percent in the radiotherapy group. The hazard ratio was 0.68 in the chemoradiotherapy group, with a median follow-up of 69.9 months. Overall survival at five-years was higher for the combined chemoradiotherapy group compared with the radiotherapy group (48 versus 35 percent), but the difference was not statistically significant (hazard ratio, 0.82; P = 0.16). In the chemoradiotherapy group, grade 3 and 4 adverse events were slightly more common during (36.0 versus 27.5 percent; P = 0.07), but not after (8.3 versus 15.7 percent; P = 0.07), treatment.
“Synchronous chemotherapy with fluorouracil and mitomycin C combined with radiotherapy significantly improved locoregional control of bladder cancer, as compared with radiotherapy alone, with no significant increase in adverse events,” the authors write.
One author disclosed financial ties to Bayer and Pfizer.