OBJECTIVE: To assess the efficacy of 60 MU intravesical alpha-2b interferon (IFN) in preventing recurrence of transitional cell carcinoma of the bladder. METHODS: A prospective, randomized double-blind study was conducted to assess the efficacy of 60 MU intravesical alpha-2b IFN compared to a control group. T1G2-G3 and the G1 recurrent tumors were included in the study (30 in each group). Instillation was started 2-3 weeks after complete TUR and administered once weekly for 12 weeks and once monthly thereafter for one year. RESULTS: The distribution according to sex and age of the patient, tumor size, grade and classification as primary or secondary was the same for both groups. Multiple tumors were prevalent in the IFN-treated group. During the first year of follow up, the tumor recurrence rate was 23.3% for the IFN-treated group and 36.6% for the control group. At 22.4 months mean follow up, the rate of recurrence was 40% for the IFN-treated group and 46.6% for the control group. Of these recurrences, 8.3% of tumors in the IFN group showed progression in grade and/or stage versus 35.7% for the control group. The disease-free interval averaged 8.5 months; 10.5 for the treated group and 6.9 months for the control group. Local or systemic toxicity was negligible. CONCLUSIONS:Alpha-2b IFN is well-tolerated at a dose of 60 MU. It prolongs the disease-free interval and while throughout the follow up period the recurrence rate is similar to that of the control group, it does seem to markedly slow progression in the grade and/or stage of the tumor.
RCT Entities:
OBJECTIVE: To assess the efficacy of 60 MU intravesical alpha-2b interferon (IFN) in preventing recurrence of transitional cell carcinoma of the bladder. METHODS: A prospective, randomized double-blind study was conducted to assess the efficacy of 60 MU intravesical alpha-2b IFN compared to a control group. T1G2-G3 and the G1 recurrent tumors were included in the study (30 in each group). Instillation was started 2-3 weeks after complete TUR and administered once weekly for 12 weeks and once monthly thereafter for one year. RESULTS: The distribution according to sex and age of the patient, tumor size, grade and classification as primary or secondary was the same for both groups. Multiple tumors were prevalent in the IFN-treated group. During the first year of follow up, the tumor recurrence rate was 23.3% for the IFN-treated group and 36.6% for the control group. At 22.4 months mean follow up, the rate of recurrence was 40% for the IFN-treated group and 46.6% for the control group. Of these recurrences, 8.3% of tumors in the IFN group showed progression in grade and/or stage versus 35.7% for the control group. The disease-free interval averaged 8.5 months; 10.5 for the treated group and 6.9 months for the control group. Local or systemic toxicity was negligible. CONCLUSIONS: Alpha-2b IFN is well-tolerated at a dose of 60 MU. It prolongs the disease-free interval and while throughout the follow up period the recurrence rate is similar to that of the control group, it does seem to markedly slow progression in the grade and/or stage of the tumor.