Bacillus Calmette-Guerin with or without interferon alpha-2b and megadose versus recommended daily allowance vitamins during induction and maintenance intravesical treatment of nonmuscle invasive bladder cancer.
Author(s): Nepple KG, Lightfoot AJ, Rosevear HM, O'Donnell MA, Lamm DL
Affiliation(s): Department of Urology, University of Iowa, Iowa City, Iowa 52242-1089, USA.
Publication date & source: 2010-11, J Urol., 184(5):1915-9. Epub 2010 Sep 17.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
PURPOSE: In a multicenter, prospectively randomized study we evaluated bacillus Calmette-Guerin alone vs bacillus Calmette-Guerin plus interferon alpha-2b and megadose vitamins vs recommended daily allowance vitamins during induction and maintenance intravesical therapy in the treatment of nonmuscle invasive bladder cancer. MATERIALS AND METHODS: Patients who were bacillus Calmette-Guerin naive with carcinoma in situ, Ta or T1 urothelial cancer were randomized to receive intravesical bacillus Calmette-Guerin or bacillus Calmette-Guerin plus interferon alpha-2b. Patients were further randomized to receive a recommended daily allowance or megadose vitamin preparation. Induction bacillus Calmette-Guerin treatment was given weekly for 6 weeks, and patients who were recurrence-free received maintenance treatment at 4, 7, 13, 19, 25 and 37 months. Patients were followed with quarterly cystoscopy for 2 years, then semiannually through year 4 and then annually. The primary end point was biopsy confirmed tumor recurrence or positive cytology. RESULTS: A total of 670 patients were accrued and randomized. At 24-month median followup recurrence-free survival was similar in all groups with 63% in the bacillus Calmette-Guerin with recommended daily allowance vitamins group, 59% in bacillus Calmette-Guerin with megadose vitamins, 55% in bacillus Calmette-Guerin/interferon alpha-2b with recommended daily allowance vitamins and 61% in bacillus Calmette-Guerin/interferon alpha-2b with megadose vitamins (p >0.05). The addition of interferon alpha-2b was associated with a more frequent incidence of fever (11% vs 5%) and constitutional symptoms (18% vs 11%) vs bacillus Calmette-Guerin alone (p <0.05). CONCLUSIONS: Interferon alpha-2b added to bacillus Calmette-Guerin induction and maintenance intravesical therapy did not decrease tumor recurrence in bacillus Calmette-Guerin naive cases, but was associated with increased fever and constitutional symptoms. No difference in time to recurrence was present in patients receiving recommended daily allowance vs high dose vitamins. Copyright (c) 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.