Prospective phase II trial of alternating intravesical Bacillus Calmette-Guérin (BCG) and interferon alpha IIB in the treatment and prevention of superficial transitional cell carcinoma of the urinary bladder: preliminary results.

Background and Objective Evaluate the efficacy and toxicity of alternating intravesical instillation of Bacillus Calmette-Guerin(BCG) and Interferon alpha2-b (IFN) in the treatment and prevention of recurrence of superficial transitional cell carcinoma (TCC) of the urinary bladder. Methods Patients with Ta, T1 tumors and carcinoma in situ, either recurrent (TaG1, T1G1) or primary/recurrent TaG2 TaG3, T1G2, T1G3 and Tis (T: Tumor stage, G: grade) are eligible. All patients received intravesical BCG 81 mg on Weeks 1, 3, 5 and 7 and IFN 100 million units on Weeks 2, 4, 6 and 8. Cystoscopy performed 4 weeks after completion of therapy, and every 3 months thereafter. Results There was a total of 37 patients. Thirteen had TaG2, 13 T1G2, 1 T1G1, 4 TaG1, 1 TaG3, 3 T1G3 and 7 Tis (5 concurrent with other above tumors). Index lesion cleared in 7/10 patients. With a median follow-up of 26.2 month, 22 patients (59%) failed above therapy. Median time to treatment failure was 7 months. Seven, 6 and 9 patients recurred at a higher, lower and same stage or grade respectively. No grade 3 or 4 toxicity was encountered. Conclusions Alternating intravesical BCG and IFN is effective and well tolerated therapy for superficial TCC of urinary bladder. J. Surg. Oncol. 2000;74:181–184. © 2000 Wiley-Liss, Inc.