Comparison of two doses of interferon-alpha-2b in intravesical prophylaxis of superficial bladder tumors. Portuguese Genito-Urinary Group.

Abstract

The purpose of the study was to compare two doses of interferon-alpha 2b (60 and 100 million units, MU) and to define the recurrence rate per year, tumor rate per year and the toxicity for both treatment arms. 127 patients were admitted to the study and randomized between the two treatments: 64 patients in the 60-MU regimen (28 single primary, 8 multiple primary, 28 recurrent), and 63 patients (22 single primary, 10 multiple primary, 31 recurrent) in the 100-MU regimen. Of the 64 patients receiving 60 MU, 26 patients had recurrences (33 recurrences with a follow-up of 2,478 months). Of the 63 patients receiving 100 MU, 21 patients had recurrences (26 recurrences with a follow-up of 2,329 months). The recurrence rate per year for 60 MU is 0.13 and 0.11 for 100 MU and the tumor rate per year is 0.34 and 0.36, respectively. In conclusion the quality of life of the patients is very good with no side effects, and, using Fisher's exact test for statistical comparison, there was no difference in the recurrence rate per year and the tumor rate per year between the 2 groups.