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.
We 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.
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.
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.
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.
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).
The monthly maintenance BCG regimen showed excellent efficacy and was significantly better in preventing recurrence than a similar regimen of EPI/IFN-α2a.
A 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.
Registration 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.
European urology. 2016 Apr 13 [Epub ahead of print]
Timo Marttila, Riikka Järvinen, Tapani Liukkonen, Erkki Rintala, Peter Boström, Marjo Seppänen, Teuvo Tammela, Pekka Hellström, Sirpa Aaltomaa, Markku Leskinen, Mika Raitanen, Eero Kaasinen, FinnBladder Group
Department of Urology, Seinäjoki Central Hospital, Seinäjoki, Finland. Electronic address: ., Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland., Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Department of Urology, Turku University Hospital, Turku, Finland., Department of Surgery, Satakunta Central Hospital, Pori, Finland., Department of Urology, Tampere University Hospital, Tampere, Finland., Department of Urology, Oulu University Hospital, Oulu, Finland., Department of Urology, Kuopio University Hospital, Kuopio, Finland., Department of Urology, Seinäjoki Central Hospital, Seinäjoki, Finland., Department of Urology, Seinäjoki Central Hospital, Seinäjoki, Finland., Department of Surgery, Hyvinkää Hospital and Helsinki University Hospital, Hyvinkää, Finland.