Results at 43 months' follow-up of a double-blind, randomized, prospective clinical trial using intravesical interferon alpha-2b in the prophylaxis of stage pT1 transitional cell carcinoma of the bladder.
OBJECTIVE
To assess the intravesical efficacy of 60 million units of interferon (IFN) alpha-2b in preventing recurrences of Stage pT1 transitional cell carcinoma of the bladder, as well as to assess its local and systemic toxicity.


METHODS
A total of 90 patients were included in a double-blind, randomized, prospective clinical trial and divided into two groups of 45 patients. After complete transurethral resection, 60 million units IFN alpha-2b was instilled in one group; in the other, double-distilled water was used. The therapeutic regimen consisted of weekly instillation for 12 weeks, followed by once-monthly instillation until patients had completed 1 year of treatment.


RESULTS
Only 78 patients were evaluable. After 12 months of follow-up, the relapse rate was 28.2% (11 of 39) for the IFN group and 35.8% (14 of 39) for the control group (P = NS). After 43 months (range 9 to 67), relapse rates were 53.8% (21 of 39) and 51.2% (20 of 39), respectively (P = NS). Progression, mortality, and local or systemic toxicity were similar in both groups. Flu-like syndrome was not reported.


CONCLUSIONS
At the dose used in this study, IFN alpha-2b proved ineffective in the prophylaxis of Stage pT1 transitional cell carcinoma of the bladder compared with a control group. Toxicity was virtually absent.
Portillo
J
J
Urology Department, Valdecilla University Hospital, Medical School, University of Cantabria, Santander, Spain.
Martin
B
B
Hernandez
R
R
Correas
M
M
Gutierrez
J
J
Del Valle
J
J
Roca
A
A
Vega
A
A
Villanueva
A
A
Gutierrez
R
R
D000283:Administration, Intravesical; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009367:Neoplasm Staging; D011446:Prospective Studies; D011994:Recombinant Proteins; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000517:prevention & control*
D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins