Mp16-15 Intravesical Electromotive Mitomycin in Patients With Bacillus Calmette-Guérin-Unresponsive Primary High Risk Non-Muscle Invasive Bladder Cancer: An Open Label, Single Arm, Phase Ii Study

You have accessJournal of UrologyBladder Cancer: Non-invasive I (MP16)1 May 2024MP16-15 INTRAVESICAL ELECTROMOTIVE MITOMYCIN IN PATIENTS WITH BACILLUS CALMETTE-GUÉRIN-UNRESPONSIVE PRIMARY HIGH RISK NON-MUSCLE INVASIVE BLADDER CANCER: AN OPEN LABEL, SINGLE ARM, PHASE II STUDY Savino Mauro Di Stasi, Giuseppe Palermo, Giovanni Capelli, Francesco Pio Bizzarri, Elena Di Stasi, Angelo Totaro, Seyed Koosha Moosavi, and Marco Racioppi Savino Mauro Di StasiSavino Mauro Di Stasi , Giuseppe PalermoGiuseppe Palermo , Giovanni CapelliGiovanni Capelli , Francesco Pio BizzarriFrancesco Pio Bizzarri , Elena Di StasiElena Di Stasi , Angelo TotaroAngelo Totaro , Seyed Koosha MoosaviSeyed Koosha Moosavi , and Marco RacioppiMarco Racioppi View All Author Informationhttps://doi.org/10.1097/01.JU.0001008640.01272.9d.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We investigated the effects of intravesical electromotive mitomycin (EMDA/MMC) in patients with primary high risk urothelial non-muscle invasive bladder cancer (NMIBC) who failed BCG therapy and were unfit or unwilling for cystectomy. METHODS: From January 2006 to December 2018, patients with histologically confirmed BCG-unresponsive high risk NMIBC were enrolled. Following transurethral resection of bladder tumor (TURBT) and re-TURBT, patients were scheduled for an initial 6 weekly intravesical EMDA/MMC treatments, a further 6 weekly treatments for non-responders and 9 monthly treatments for responders. Patient follow-ups were done every 3 months for the first 2 years and every 6 months thereafter. Primary end-points were the complete response rate (absence of high-risk NMIBC or progressive disease) at 3 months for carcinoma in situ (Cis) and recurrence-free survival for fully resected papillary disease. Secondary end points include disease progression, overall survival and disease-specific survival. Analysis were done by intention-to-treat. Clinical-Trial.Gov, number NCT04311580. RESULTS: From January 2006 to December 2018, 191 patients were enrolled and 89 (48 with Cis and 41 with papillary disease alone), according to the US FDA definition of BCG-unresponsive NMIBC, were included in the efficacy and safety analyses. Median follow-up of 40 months (IQR 58-27). Of 48 patients with Cis, 23 (47.9% 95% CI: 33.3-62.8, 26 (54.2% 39.2-68.6), 19 (39.6% 25.8-54.7), 12 (25% 13.6-39.6), and 11 (22.9% 12.0-37.3), had a complete response at 3, 6, 12, 18 and 24 months respectively. Of 41 patients with papillary disease alone, 38 (92.7% 95% CI: 80.1-98.5), 32 (78.1% [62.4-89.4), 29 (70.7 [54.5-63.9), 20 (48.8% 32.9-54.9), and 17 (41.5% [26.3-57.9) were recurrence-free 3, 6, 12, 18 and 24 months. Overall, patients with papillary disease alone than those with Cis alone had lower high grade recurrence (24.4% 12.4-40.3 vs 64.6% 49.5-77.4; log-rank p=0.0002); progression (14.6% 5.6-29.2 vs 41.727.6-56.8; p=0.0554); overall mortality (39 % 24.2-55.5 vs 68.7% 53.7-81,3; p=0.9379); and disease-specific mortality (4.9% 0.6-16.5 vs 20.810.5-35; p=0.1465]. Treatment-related adverse events were localised to the lower urinary tract. CONCLUSIONS: Intravesical EMDA/MMC is a safe and therapeutic option for patients with high risk NMIBC who fail BCG treatment. As BCG may induces delayed and longer cell mediated immunity after immunization, the FDA guidelines for patients with BCG failure should be reviewed. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e246 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Savino Mauro Di Stasi More articles by this author Giuseppe Palermo More articles by this author Giovanni Capelli More articles by this author Francesco Pio Bizzarri More articles by this author Elena Di Stasi More articles by this author Angelo Totaro More articles by this author Seyed Koosha Moosavi More articles by this author Marco Racioppi More articles by this author Expand All Advertisement PDF downloadLoading ...