• Timo Marttila, Riikka Järvinen, Tapani Liukkonen, Erkki Rintala, Peter Boström, Marjo Seppänen, Teuvo Tammela, Pekka Hellström, Sirpa Aaltomaa, Markku Leskinen, Mika Raitanen, Eero Kaasinen, and FinnBladder Group.
• Department of Urology, Seinäjoki Central Hospital, Seinäjoki, Finland. Electronic address: timo.marttila@epshp.fi.
• Eur. Urol. 2016 Aug 1; 70 (2): 341-7.

BackgroundPatients with non-muscle-invasive bladder cancer (NMIBC) belonging to the intermediate-risk group should be treated with intravesical instillations to prevent recurrence and progression.ObjectiveWe compared the outcome of a monthly maintenance bacillus Calmette-Guérin (BCG) regimen with that of epirubicin (EPI) and interferon-α2a (IFN) in patients with NMIBC.Design, Setting, And ParticipantsOur prospective randomized multicenter study comprised 229 eligible patients with frequently recurrent TaT1 grade 1-2 or low-grade NMIBC enrolled between 1997 and 2008.InterventionsThe 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 AnalysisTime 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 LimitationsThe 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).ConclusionsThe monthly maintenance BCG regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of EPI/IFN-α2a.Patient SummaryA monthly bacillus Calmette-Guérin (BCG) regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of epirubicin and interferon-α2a.Trial RegistrationRegistration was not considered necessary at this stage of the follow-up because the study was initiated as early as in 1997, before the current requirements concerning study registrations were implemented.Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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