Randomized noninferiority trial of reduced high-dose volume versus standard volume radiation therapy for muscle-invasive bladder cancer: results of the BC2001 trial (CRUK/01/004).
Bottom Line: The difference in 2-year locoregional recurrence free rate (RHDVRT - sRT) was 6.4% (95% confidence interval -7.3%, 16.8%) under an intention to treat analysis and 2.6% (-12.8%, 14.6%) in the "per-protocol" population.In this study RHDVRT did not result in a statistically significant reduction in late side effects compared with sRT, and noninferiority of locoregional control could not be concluded formally.However, overall low rates of clinically significant toxicity combined with low rates of invasive bladder cancer relapse confirm that (chemo)radiation therapy is a valid option for the treatment of muscle-invasive bladder cancer.
Affiliation: Institute of Cancer Research. email@example.comShow MeSH
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Mentions: The overall cumulative G3/4 RTOG toxicity rate was 13% (95% CI 8%, 20%) at 2 years (Fig. 2a), whereas the percentage of patients with G3/4 toxicity at any specific point was <8% throughout (Fig. 3) in both groups. Genitourinary toxicity was more prevalent than gastrointestinal; the most common G3/4 toxicities reported were hematuria (7 patients), urethral stricture (6 patients), and cystitis (5 patients).
Affiliation: Institute of Cancer Research. firstname.lastname@example.org