Long-term follow-up of cytostatic intravesical instillation in patients with superficial bladder carcinoma. Is short-term, intensive instillation better than maintenance therapy?
OBJECTIVE
Comparisons of two 3-year protocols, one 20-week protocol of mitomycin C instillation and one 3-year protocol of doxorubicin instillation for the prevention of recurrent tumors and progression in patients whose superficial bladder tumors had been removed by transurethral resection.


METHODS
A prospective, randomized parallel group multicenter trial was conducted. 419 patients were evaluated after a median follow-up of 57 months. Cox proportional hazards analysis was performed.


RESULTS
An overall recurrence rate of 22.7% and an overall progression rate of 9.8% was found. For time to progression a significant overall treatment effect was detected dependent on the recurrence status before entry into the study (p = 0.0059). Pairwise comparisons showed the mitomycin protocol with short-term intensive (weekly) combined with long-term maintenance instillation to have a highly beneficial effect compared to long-term maintenance instillation only especially for patients entering the study with recurrent tumors (RR = 0.06, 95% CI: [0.008, 0.506].


CONCLUSIONS
These results show that intensive therapeutic instillation may have an advantage over less intensive, prophylactic regimens.
Schwaibold
H
H
Department of Urology, University of Hamburg-Eppendorf, Germany.
Pichlmeier
U
U
Klingenberger
H J
HJ
Huland
H
H
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003558:Cystoscopy; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000627:therapeutic use; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000517:prevention & control; D011446:Prospective Studies; D012044:Regression Analysis; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
D000903:Antibiotics, Antineoplastic; D016685:Mitomycin; D004317:Doxorubicin