Bacillus Calmette-Guerin With or Without Interferon α-2b and Megadose Versus Recommended Daily Allowance Vitamins During Induction and Maintenance Intravesical Treatment of Nonmuscle Invasive Bladder Cancer.

12:35 EDT 4th September 2015 | BioPortfolio

Summary of "Bacillus Calmette-Guerin With or Without Interferon α-2b and Megadose Versus Recommended Daily Allowance Vitamins During Induction and Maintenance Intravesical Treatment of Nonmuscle Invasive Bladder Cancer."


PURPOSE:
: In a multicenter, prospectively randomized study we evaluated bacillus Calmette-Guerin alone vs bacillus Calmette-Guerin plus interferon α-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 naïve with carcinoma in situ, Ta or T1 urothelial cancer were randomized to receive intravesical bacillus Calmette-Guerin or bacillus Calmette-Guerin plus interferon α-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 α-2b with recommended daily allowance vitamins and 61% in bacillus Calmette-Guerin/interferon α-2b with megadose vitamins (p >0.05). The addition of interferon α-2b was associated with a more frequent incidence of fever (11% vs 5%) and constitutional symptoms (18% vs 11%) vs bacillus Calmette-Guerin alone.
CONCLUSIONS:
: Interferon α-2b added to bacillus Calmette-Guerin induction and maintenance intravesical therapy did not decrease tumor recurrence in bacillus Calmette-Guerin naïve 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.

Affiliation

Department of Urology, University of Iowa, Iowa City, Iowa.

Journal Details

This article was published in the following journal.

Name: The Journal of urology
ISSN: 1527-3792
Pages:

Links

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Medical and Biotech [MESH] Definitions

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.

A family of transcription factors that share an N-terminal HELIX-TURN-HELIX MOTIF and bind INTERFERON-inducible promoters to control GENE expression. IRF proteins bind specific DNA sequences such as interferon-stimulated response elements, interferon regulatory elements, and the interferon consensus sequence.

A type II interferon produced by recombinant DNA technology. It is similar to the interferon secreted by lymphocytes and has antiviral and antineoplastic activity.

Viruses whose host is Bacillus. Frequently encountered Bacillus phages include bacteriophage phi 29 and bacteriophage phi 105.


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