Long-term intravesical adjuvant chemotherapy further reduces recurrence rate compared with short-term intravesical chemotherapy and short-term therapy with Bacillus Calmette-Guérin (BCG) in patients with non-muscle-invasive bladder carcinoma.
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.
Friedrich
Martin G
MG
Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. friedric@uke.uni-hamburg.de
Pichlmeier
Uwe
U
Schwaibold
Hartwig
H
Conrad
Stefan
S
Huland
Hartwig
H
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000627:therapeutic use; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D009367:Neoplasm Staging; D012044:Regression Analysis; D016019:Survival Analysis; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
D000970:Antineoplastic Agents; D001500:BCG Vaccine; D016685:Mitomycin