A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27 mg) versus very low-dose bacillus Calmette-Guerin (13.5 mg) versus mitomycin C.
OBJECTIVE
The primary aim was to search for lower doses of Bacillus Calmette-Guerin (BCG) that are effective and have lower toxicity.


METHODS
A low dose of BCG 27 mg was compared with BCG 13.5mg, using mitomycin C (MMC) 30 mg as the third arm of comparison. A total of 430 patients with intermediate-risk superficial bladder cancer were randomised into three groups. Instillations were repeated once a week for 6 wk followed by another six instillations given once every 2 wk during 12 wk.


RESULTS
There was a significantly longer disease-free interval for BCG 27 mg versus MMC 30 mg (p=0.006). There were no statistically significant differences between BCG 27 mg and BCG 13.5mg (p=0.165) or between BCG 13.5mg and MMC 30 mg (p=0.183). Cox proportional hazards regression showed that disease-free interval in the multivariate analysis was significantly better for primary disease and treatment with BCG 27 mg. There were no significant differences among the three groups with regards to time to progression and cancer-specific survival time. Local and systemic toxicity were higher in both BCG treatment groups.


CONCLUSIONS
One third of the standard dose, BCG 27 mg, seems to be the minimum effective dose as adjuvant treatment for intermediate-risk superficial bladder cancer, being more effective than MMC 30 mg. One sixth of the standard dose, BCG 13.5mg, has the same efficacy as MMC 30 mg but it is more toxic.
Ojea
Antonio
A
Complejo Hospitalario Universitario de Vigo, Vigo, Spain. aojea@retegal.es
Nogueira
José Luís
JL
Solsona
Eduardo
E
Flores
Nicolás
N
Gómez
Jesús María Fernández
JM
Molina
Jesús Rodríguez
JR
Chantada
Venancio
V
Camacho
José Emilio
JE
Piñeiro
Luís Martínez
LM
Rodríguez
Rafael Hernandez
RH
Isorna
Santiago
S
Blas
Miguel
M
Martínez-Piñeiro
José A
JA
Madero
Rosario
R
D000283:Administration, Intravesical; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage*; D001706:Biopsy; D017024:Chemotherapy, Adjuvant / Q000379:methods; D015653:Cystectomy / Q000379:methods*; D003558:Cystoscopy; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D016685:Mitomycin / Q000008:administration & dosage*; D009367:Neoplasm Staging; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*
D001500:BCG Vaccine; D016685:Mitomycin