You have accessJournal of UrologyBladder Cancer: Non-invasive II1 Apr 2015PD17-02 IS INTRAVESICAL BCG ALONE STILL THE ONLY TRULY EFFECTIVE INTRAVESICAL THERAPY FOR NON-MUSCLE INVASIVE BLADDER CANCER? Savino Mauro Di Stasi, Claus Riedl, Antonella Giannantoni, Cristian Verri, Francesco Celestino, Francesco De Carlo, Francesco Masedu, and Marco Valenti Savino Mauro Di StasiSavino Mauro Di Stasi More articles by this author , Claus RiedlClaus Riedl More articles by this author , Antonella GiannantoniAntonella Giannantoni More articles by this author , Cristian VerriCristian Verri More articles by this author , Francesco CelestinoFrancesco Celestino More articles by this author , Francesco De CarloFrancesco De Carlo More articles by this author , Francesco MaseduFrancesco Masedu More articles by this author , and Marco ValentiMarco Valenti More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.659AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In a randomized prospective trial it has been shown that intravesical sequential bacillus Calmette-Guerin (BCG) and electro-osmotic delivery (IVED) of mitomycin (MMC) is superior to BCG alone in patients with stage pT1 bladder cancer. A 5-year and 10-year contemporary cost-effectiveness study of these 2 treatment strategies suggests that sequential therapy is also cost-effective in this indication. After an additional 6 years of follow-up, we report estimated 10-year results. METHODS From January 1994 through June 2002, we randomly assigned 212 patients with stage pT1 bladder cancer to either 81 mg BCG once a week for 6 weeks (n=105) or to 81 mg BCG once a week for 2 weeks, followed by IVED of 40 mg MMC (intravesical pulsed electric current 20 mA for 30 min) once a week, and this cycle was repeated 3 times (n=107). Complete responders underwent maintenance treatment: those assigned to BCG alone had one instillation of 81 mg BCG once a month for 10 months, and those assigned to sequential therapy had 40 mg MMC once a month for 2 months, followed by 81 mg BCG once a month and this cycle again repeated three times. The primary endpoint was disease-free interval; secondary endpoints were time to progression; overall survival; and disease-specific survival. Analyses were done by intention to treat. RESULTS Median follow-up was 121 months (IQR 70.5–163.5). Patients assigned to sequential BCG and IVED of MMC had higher disease-free intervals than those assigned to BCG alone (79 months [95% CI 27–139] vs 26 months [11–113]; log-rank p=0.0002. Patients assigned to sequential BCG and IVED of MMC also had a lower recurrence rate (45% [35–55] vs 62% [50–72], log-rank p=0.0002; progression (12% [3–21] vs 28% [17.5–38.5], log-rank p=0.003); overall mortality (44% [33–55] vs 59% [43–75], log-rank p=0.01; and disease-specific mortality (9% [2.5– 15.5] vs 23% [11–34], log-rank p=0.0055. Side-effects were mainly localised to the lower urinary tract. MMC pharmacokinetics showed that plasma levels remained well below toxic concentrations. CONCLUSIONS These long-term data confirm former studies and suggest that intravesical sequential BCG and IVED of MMC is a superior and cost-effective treatment that has the potential to be integrated into hospital and health systems as a standard of care. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e381 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Savino Mauro Di Stasi More articles by this author Claus Riedl More articles by this author Antonella Giannantoni More articles by this author Cristian Verri More articles by this author Francesco Celestino More articles by this author Francesco De Carlo More articles by this author Francesco Masedu More articles by this author Marco Valenti More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...