1474 SEQUENTIAL CHEMO-IMMUNOTHERAPY WITH MITOMYCIN C (MMC) AND BACILLUS CALMETTE-GUERIN (BCG) VERSUS BCG ALONE IN PATIENTS WITH CARCINOMA IN SITU (CIS) OF THE URINARY BLADDER. RESULTS OF EORTC GU GROUP RANDOMIZED PHASE II STUDY 30993

Abstract

You have accessJournal of UrologyBladder Cancer: Superficial II1 Apr 20101474 SEQUENTIAL CHEMO-IMMUNOTHERAPY WITH MITOMYCIN C (MMC) AND BACILLUS CALMETTE-GUERIN (BCG) VERSUS BCG ALONE IN PATIENTS WITH CARCINOMA IN SITU (CIS) OF THE URINARY BLADDER. RESULTS OF EORTC GU GROUP RANDOMIZED PHASE II STUDY 30993 Ziya Kirkali, Willem Oosterlinck, Richard Sylvester, Fernando Calais Da Silva, Christer Busch, Ferran Algaba, Sandra Collette, and Aldo Bono Ziya KirkaliZiya Kirkali Izmir, Turkey More articles by this author , Willem OosterlinckWillem Oosterlinck Ghent, Belgium More articles by this author , Richard SylvesterRichard Sylvester Brussels, Belgium More articles by this author , Fernando Calais Da SilvaFernando Calais Da Silva Lisbon, Portugal More articles by this author , Christer BuschChrister Busch Uppsala, Sweden More articles by this author , Ferran AlgabaFerran Algaba Barcelona, Spain More articles by this author , Sandra ColletteSandra Collette Brussels, Belgium More articles by this author , and Aldo BonoAldo Bono Varese, Italy More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1189AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES BCG is the intravesical treatment of choice according to American and European guidelines for the treatment of non muscle invasive bladder cancer (NMIBC) patients with CIS. Complete response (CR) rates of 65 to 70% can be expected on BCG. MMC is widely used in the chemotherapeutic treatment of NMIBC, especially in patients with only papillary disease. As a possible synergistic effect between MMC and BCG may be expected, this study was undertaken to assess the activity of sequential MMC-BCG versus BCG alone in the post transurethral resection (TUR) treatment of NMIBC patients with CIS. METHODS NMIBC patients with biopsy proven primary, secondary or concurrent CIS were randomized within 28 days after TUR of all visible tumor to either weekly MMC (6 instillations) followed by weekly BCG (6 instillations) or weekly BCG (6 instillations, 3 weeks rest, 3 instillations). Complete responders also received 3 weekly maintenance instillations at 6, 12, 18, 24, 30 and 36 months in accordance with the initial randomisation. Patients with muscle invasive tumors or tumors in the upper urinary tract were ineligible. The primary endpoint was the CR rate at the first control cystoscopy 16 to 18 weeks after start of treatment. RESULTS From June 2001 to February 2005, 96 patients were randomized, 48 to each treatment. 10 of 96 patients were ineligible: CIS was not confirmed by central pathology review in 8 patients. 3 patients did not start treatment. In the intent to treat population of all randomized patients, the CR rates on MMC + BCG and BCG alone were 70.8% and 66.7%, respectively. In the 83 eligible patients who started treatment, the CR rates were 75.6% and 73.8%, respectively. Based on a median follow up of 4.7 years, 23 patients (47.9%) on MMC + BCG and 26 patients (54.2%) on BCG alone have failed treatment, including 9 and 10 of the CRs, respectively. Seven patients (7.3%) progressed to muscle invasive disease, 6 (6.3%) developed distant metastases, 13 (13.5%) had a cystectomy and 18 (18.8%) died, 6 (6.3%) due to bladder cancer. Treatment was relatively well tolerated, 12 patients stopped treatment due to toxicity: 3 during induction (2 MMC + BCG, 1 BCG) and 9 during maintenance (3 MMC + BCG, 6 BCG). CONCLUSIONS Sequential chemo-immunotherapy with MMC + BCG is feasible, but there was no suggestion of a possible synergistic effect. Both treatment groups had acceptable toxicity and yielded similar complete response rates in the treatment of patients with CIS of the urinary bladder. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e568 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ziya Kirkali Izmir, Turkey More articles by this author Willem Oosterlinck Ghent, Belgium More articles by this author Richard Sylvester Brussels, Belgium More articles by this author Fernando Calais Da Silva Lisbon, Portugal More articles by this author Christer Busch Uppsala, Sweden More articles by this author Ferran Algaba Barcelona, Spain More articles by this author Sandra Collette Brussels, Belgium More articles by this author Aldo Bono Varese, Italy More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...