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Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance.
Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance.
- Source :
-
European urology [Eur Urol] 2013 Mar; Vol. 63 (3), pp. 462-72. Date of Electronic Publication: 2012 Nov 02. - Publication Year :
- 2013
-
Abstract
- Background: The optimal dose and duration of intravesical bacillus Calmette-Guérin (BCG) in the treatment of non-muscle-invasive bladder cancer (NMIBC) are controversial.<br />Objective: To determine if a one-third dose (1/3D) is not inferior to the full dose (FD), if 1 yr of maintenance is not inferior to 3 yr of maintenance, and if 1/3D and 1 yr of maintenance are associated with less toxicity.<br />Design, Setting, and Participants: After transurethral resection, intermediate- and high-risk NMIBC patients were randomized to one of four BCG groups: 1/3D-1 yr, 1/3D-3 yr, FD-1 yr, and FD-3 yr.<br />Outcome Measurements and Statistical Analysis: The trial was designed as a noninferiority study with the null hypothesis of a 10% decrease in the disease-free rate at 5 yr. Times to events were estimated using cumulative incidence functions and compared using the Cox proportional hazards regression model.<br />Results and Limitations: In an intention-to-treat analysis of 1355 patients with a median follow-up of 7.1 yr, there were no significant differences in toxicity between 1/3D and FD. The null hypotheses of inferiority of the disease-free interval for both 1/3D and 1 yr could not be rejected. We found that 1/3D-1 yr is suboptimal compared with FD-3 yr (hazard ratio [HR]: 0.75; 95% confidence interval [CI], 0.59-0.94; p=0.01). Intermediate-risk patients treated with FD do not benefit from an additional 2 yr of BCG. In high-risk patients, 3 yr is associated with a reduction in recurrence (HR: 1.61; 95% CI, 1.13-2.30; p=0.009) but only when given at FD. There were no differences in progression or survival.<br />Conclusions: There were no differences in toxicity between 1/3D and FD. Intermediate-risk patients should be treated with FD-1 yr. In high-risk patients, FD-3 yr reduces recurrences as compared with FD-1 yr but not progressions or deaths. The benefit of the two additional years of maintenance should be weighed against its added costs and inconvenience.<br />Trial Registration: This study was registered at ClinicalTrials.gov, number NCT00002990; http://clinicaltrials.gov/ct2/show/record/NCT00002990.<br /> (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
BCG Vaccine adverse effects
Carcinoma, Papillary mortality
Carcinoma, Papillary pathology
Carcinoma, Papillary surgery
Disease Progression
Dose-Response Relationship, Immunologic
Female
Follow-Up Studies
Humans
Male
Middle Aged
Neoplasm Invasiveness
Neoplasm Recurrence, Local mortality
Neoplasm Recurrence, Local prevention & control
Patient Dropouts
Proportional Hazards Models
Risk Factors
Treatment Outcome
Urinary Bladder Neoplasms mortality
Urinary Bladder Neoplasms pathology
Urinary Bladder Neoplasms surgery
BCG Vaccine administration & dosage
Carcinoma, Papillary therapy
Urinary Bladder Neoplasms therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1873-7560
- Volume :
- 63
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- European urology
- Publication Type :
- Academic Journal
- Accession number :
- 23141049
- Full Text :
- https://doi.org/10.1016/j.eururo.2012.10.039