A1 Refereed original research article in a scientific journal
Intravesical Bacillus Calmette-Guerin Versus Combination of Epirubicin and Interferon-alpha 2a in Reducing Recurrence of Non-Muscle-invasive Bladder Carcinoma: FinnBladder-6 Study
Authors: Timo Marttila, Riikka Järvinen, Tapani Liukkonen, Erkki Rintala, Peter Boström, Marjo Seppänen, Teuvo Tammela, Pekka Hellström, Sirpa Aaltomaa, Markku Leskinen, Mika Raitanen, Eero Kaasinen
Publisher: ELSEVIER SCIENCE BV
Publication year: 2016
Journal: European Urology
Journal name in source: EUROPEAN UROLOGY
Journal acronym: EUR UROL
Volume: 70
Issue: 2
First page : 341
Last page: 347
Number of pages: 7
ISSN: 0302-2838
DOI: https://doi.org/10.1016/j.eururo.2016.03.034
Abstract
Background: Patients with non-muscle-invasive bladder cancer (NMIBC) belonging to the intermediate-risk group should be treated with intravesical instillations to prevent recurrence and progression.Objective: We compared the outcome of a monthly maintenance bacillus Calmette-Guerin (BCG) regimen with that of epirubicin (EPI) and interferon-alpha 2a (IFN) in patients with NMIBC.Design, setting, and participants: Our prospective randomized multicenter study comprised 229 eligible patients with frequently recurrent TaT1 grade 1-2 or low-grade NMIBC enrolled between 1997 and 2008.Interventions: The four-arm study involved a single perioperative instillation of EPI plus five weekly instillations of BCG or EPI/IFN, followed by 11 monthly instillations in the 1-yr BCG or EPI/IFN maintenance arms, further followed by four additional quarterly instillations in the two 2-yr maintenance arms.Outcome measurements and statistical analysis: Time to recurrence, progression, disease-specific survival, and overall mortality were analyzed using the Kaplan-Meier and cumulative incidence analyses plus the Cox and proportional subdistribution hazards models.Results and limitations: The median follow-up time was 7.5 and 7.4 yr in the BCG and EPI/IFN groups, respectively. The probability of recurrence was significantly lower in the BCG group than in the EPI/IFN group. The probability was 39% versus 72% at 7.4 yr, respectively (hazard ratio [HR]: 0.41; 95% confidence interval [CI], 0.28-0.60; p < 0.001). There was no significant difference in the probability of progression or in overall survival. However, there was a significant difference in disease-specific mortality in favor of the BCG group (HR: 0.20; 95% CI, 0.04-0.91; p = 0.04).Conclusions: The monthly maintenance BCG regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of EPI/IFN-alpha 2a.Patient summary: A monthly bacillus Calmette-Guerin (BCG) regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of epirubicin and interferon-alpha 2a. (C) 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Background: Patients with non-muscle-invasive bladder cancer (NMIBC) belonging to the intermediate-risk group should be treated with intravesical instillations to prevent recurrence and progression.Objective: We compared the outcome of a monthly maintenance bacillus Calmette-Guerin (BCG) regimen with that of epirubicin (EPI) and interferon-alpha 2a (IFN) in patients with NMIBC.Design, setting, and participants: Our prospective randomized multicenter study comprised 229 eligible patients with frequently recurrent TaT1 grade 1-2 or low-grade NMIBC enrolled between 1997 and 2008.Interventions: The four-arm study involved a single perioperative instillation of EPI plus five weekly instillations of BCG or EPI/IFN, followed by 11 monthly instillations in the 1-yr BCG or EPI/IFN maintenance arms, further followed by four additional quarterly instillations in the two 2-yr maintenance arms.Outcome measurements and statistical analysis: Time to recurrence, progression, disease-specific survival, and overall mortality were analyzed using the Kaplan-Meier and cumulative incidence analyses plus the Cox and proportional subdistribution hazards models.Results and limitations: The median follow-up time was 7.5 and 7.4 yr in the BCG and EPI/IFN groups, respectively. The probability of recurrence was significantly lower in the BCG group than in the EPI/IFN group. The probability was 39% versus 72% at 7.4 yr, respectively (hazard ratio [HR]: 0.41; 95% confidence interval [CI], 0.28-0.60; p < 0.001). There was no significant difference in the probability of progression or in overall survival. However, there was a significant difference in disease-specific mortality in favor of the BCG group (HR: 0.20; 95% CI, 0.04-0.91; p = 0.04).Conclusions: The monthly maintenance BCG regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of EPI/IFN-alpha 2a.Patient summary: A monthly bacillus Calmette-Guerin (BCG) regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of epirubicin and interferon-alpha 2a. (C) 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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