Adding chemotherapy to radiotherapy (RT) for muscle-invasive bladder cancer is well tolerated and improves loco-regional disease-free survival (LRDFS) compared with RT alone, according to a study presented at the 52nd Annual Meeting of the American Society for Radiation Oncology (ASTRO).
“The trial shows that this treatment offers improved control of cancer within the bladder with acceptable long-term side effects and is therefore a viable alternative to radical surgery in patients with muscle-invasive bladder cancer,” said Nicholas James, MD, of the University of Birmingham, England, United Kingdom, who jointly led the study with Robert Huddart, MD, from the Institute of Cancer Research in the United Kingdom. “This may shift the balance from surgery to chemo-radiotherapy as the primary treatment for many patients with invasive bladder cancer.”
The 458 patients enrolled in the multicenter trial were randomly assigned to treatment with chemotherapy (mitomycin C and 5-fluorouracil) plus radiotherapy (CRT) or RT alone and/or to standard RT (sRT) versus reduced high-dose volume RT (rvRT).
With 40 months median follow-up, LRDFS was significantly better in patients who received CRT compared with RT alone. Two-year event-free rates were 71% with CRT and 58% with RT. Two-year overall survival (OS) was 63% and 58% in the CRT and RT groups, respectively. Neither LRDFS nor OS was significantly different between groups receiving sRT or rvRT. The overall cystectomy rate was 10% with no differences between treatment groups.
Overall, 49 (11.2%) patients experienced grade 3/4 toxicity during follow-up.