The evidence from this protocol comes from the Bladder Cancer 2001 study, a multicentre randomised phase 3 trial supported by Cancer Research UK and The National Cancer Research Network, reported by James et alr While there is no comparison to cystectomy alone the results are comparable to historical series for treatment with cystectomy.
The trial compared radiation therapy alone or with synchronous chemotherapy, a combination of Mitomycin and 5FU (fluorouracil) in patients with muscle invasive bladder cancer. Mitomycin 12mg/m2 was administered on day one and fluorouracil 500mg/m2/day was administered over 5 days starting on days 1 and 16 of radiation therapy. Patients were also randomly assigned to undergo whole bladder radiation therapy or modified volume radiation therapy.
A total of 360 patients were enrolled into the study, over 7 years in 43 UK centres. 118 patients had received neo-adjuvant chemotherapy. The primary endpoint was locoregional disease free survival. Secondary endpoints were disease free survival, metastases-free survival and toxic effects.
After a median follow up of 69.9 months the addition of chemotherapy to standard dose radiation therapy was associated with a relative reduction of 33% in the risk of locoregional recurrence.r There was a non-significant trend to improved overall survival. There was also a non-significant trend towards reduction in rate of cystectomy at 2 yr 11.4% vs 16.8% (p=0.07)
© New England Journal of Medicine 2012
|2 year Locoregional DFS
||67% (95%CI, 59 to 74)
||54% (95%CI, 46 to 62)
||0.68; (95%CI, 0.48 to 0.96) p=0.03
|5 year Overall Survival
||48% (95%CI 40 to 55)
||35% (95%CI, 28-43)
||0.82 (95%CI, 0.63 to 1.09) p=0.16
The following table outlines the toxicities reported in Bladder Cancer 2001 study.r
Chemoradiation therapy (n= 178)
|Radiation therapy (n=182)
|Any event Grade 3-5
|Genitourinary Grade 3-5
|Gastrointestinal Grade 3-5
Other toxicities and Quality of Life data were not reported
© The New England Journal of Medicine 2012