OBJECTIVE: We present a randomised, parallel group, multicentre phase 4 trial comparing short- and long-term chemoprophylaxis with Mitomycin C (MMC) with short-term immunoprophylaxis with Bacillus Calmette-Guérin (BCG) after transurethral resection of the bladder for non-muscle-invasive bladder carcinoma. METHODS:Four hundred ninety-five patients with intermediate- to high-risk non-muscle-invasive bladder cancer (recurrent and/or multifocal pTaG1, TaG2-3, and T1G1-3) were randomised to BCG RIVM 2 x 10(8) CFU weekly for 6 wk, MMC 20 mg weekly for 6 wk, or MMC 20 mg weekly for 6 wk followed by monthly instillations for 3 yr. RESULTS: The 3-yr recurrence-free rates were 65.5% (95%CI, 55.9-73.5%) for short-term BCG, and 68.6% (59.9-75.7%) for short-term MMC, whereas recurrence-free rates were significantly increased to 86.1% (77.9-91.4%) in patients with MMC long-term therapy (log-rank test, p=0.001). CONCLUSIONS: Long-term MMC significantly reduced the risk of tumour recurrence without enhanced toxicity compared with both short-term BCG and MMC in patients with intermediate- and high-risk non-muscle-invasive bladder carcinoma. Our data provide a rationale for maintenance intravesical chemotherapy in this population.
RCT Entities:
OBJECTIVE: We present a randomised, parallel group, multicentre phase 4 trial comparing short- and long-term chemoprophylaxis with Mitomycin C (MMC) with short-term immunoprophylaxis with Bacillus Calmette-Guérin (BCG) after transurethral resection of the bladder for non-muscle-invasive bladder carcinoma. METHODS: Four hundred ninety-five patients with intermediate- to high-risk non-muscle-invasive bladder cancer (recurrent and/or multifocal pTaG1, TaG2-3, and T1G1-3) were randomised to BCG RIVM 2 x 10(8) CFU weekly for 6 wk, MMC 20 mg weekly for 6 wk, or MMC 20 mg weekly for 6 wk followed by monthly instillations for 3 yr. RESULTS: The 3-yr recurrence-free rates were 65.5% (95%CI, 55.9-73.5%) for short-term BCG, and 68.6% (59.9-75.7%) for short-term MMC, whereas recurrence-free rates were significantly increased to 86.1% (77.9-91.4%) in patients with MMC long-term therapy (log-rank test, p=0.001). CONCLUSIONS: Long-term MMC significantly reduced the risk of tumour recurrence without enhanced toxicity compared with both short-term BCG and MMC in patients with intermediate- and high-risk non-muscle-invasive bladder carcinoma. Our data provide a rationale for maintenance intravesical chemotherapy in this population.
Authors: Maha H A Hussain; David P Wood; Dean F Bajorin; Bernard H Bochner; Robert Dreicer; Donald L Lamm; Michael A O'Donnell; Arlene O Siefker-Radtke; Dan Theodorescu; Colin P Dinney Journal: J Clin Oncol Date: 2009-10-26 Impact factor: 44.544
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Authors: Wassim Kassouf; Armen Aprikian; Peter Black; Girish Kulkarni; Jonathan Izawa; Libni Eapen; Adrian Fairey; Alan So; Scott North; Ricardo Rendon; Srikala S Sridhar; Tarik Alam; Fadi Brimo; Normand Blais; Chris Booth; Joseph Chin; Peter Chung; Darrel Drachenberg; Yves Fradet; Michael Jewett; Ron Moore; Chris Morash; Bobby Shayegan; Geoffrey Gotto; Neil Fleshner; Fred Saad; D Robert Siemens Journal: Can Urol Assoc J Date: 2016-02-08 Impact factor: 1.862