Journal article
Final results from a national multicenter phase II trial of combination bacillus Calmette-Guérin plus interferon α-2B for reducing recurrence of superficial bladder cancer
Urologic oncology, Vol.24(4), pp.344-348
2006
DOI: 10.1016/j.urolonc.2005.11.026
PMID: 16818189
Abstract
Both bacillus Calmette-Guérin (BCG) and interferon-alpha (IFN-α) express activity against superficial bladder cancer. The results of a national multicenter phase II trial of a combination of these 2 agents used in a wide range of patients are reported.
Patients previously having BCG failure received IFN-α (50 million units) plus reduced dose BCG, while patients naïve to BCG received the same IFN-α dose with standard dose BCG. All patients who were relapse free received an additional 3 series of 3-week reduced dose BCG plus IFN-α treatments at 3, 9, and 15 months after completing induction. Any relapse during the 3-month evaluation was counted as a failure of therapy for Kaplan-Meier analysis. Multivariate analysis was performed to identify factors associated with recurrence.
Of 1,007 valuable patients, 59% and 45% of patients naïve to BCG and those having BCG failure, respectively, remained disease free at 24-month median follow-up. Stage T1, tumor size >5 cm, prior BCG failure more than once, and multifocality were all statistically significant risk factors for recurrence.
Although BCG plus IFN-α can be effectively applied to both patients naïve to BCG and those having BCG failure, certain patient and tumor characteristics influence durable response.
Details
- Title: Subtitle
- Final results from a national multicenter phase II trial of combination bacillus Calmette-Guérin plus interferon α-2B for reducing recurrence of superficial bladder cancer
- Creators
- Fadi N Joudi - Department of Urology, University of Iowa, Iowa City, IA 52242-1089, USABrian J Smith - Department of Biostatistics, University of Iowa, Iowa City, IA 52242-1089, USAMichael A O’Donnell - Department of Urology, University of Iowa, Iowa City, IA 52242-1089, USANational BCG-Interferon Phase 2 Investigator Group
- Resource Type
- Journal article
- Publication Details
- Urologic oncology, Vol.24(4), pp.344-348
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.urolonc.2005.11.026
- PMID
- 16818189
- ISSN
- 1078-1439
- eISSN
- 1873-2496
- Language
- English
- Date published
- 2006
- Academic Unit
- Biostatistics; Urology; Holden Comprehensive Cancer Center
- Record Identifier
- 9983997455002771
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