1783 SAFETY OF INTRAVESICAL MYCOBACTERIAL CELL WALL-DNA COMPLEX GIVEN IMMEDIATELY POSTSURGERY IN PATIENTS WITH NON-MUSCLE-INVASIVE BLADDER CANCER (2012)

You have accessJournal of UrologyBladder Cancer: Superficial II1 Apr 20121783 SAFETY OF INTRAVESICAL MYCOBACTERIAL CELL WALL-DNA COMPLEX GIVEN IMMEDIATELY POSTSURGERY IN PATIENTS WITH NON-MUSCLE-INVASIVE BLADDER CANCER Alvaro Morales, David Jablonski, Christine Lihou, Zhihui Lang, and Zvi Cohen Alvaro MoralesAlvaro Morales Kingston, Canada More articles by this author , David JablonskiDavid Jablonski Orlando, FL More articles by this author , Christine LihouChristine Lihou Chadds Ford, PA More articles by this author , Zhihui LangZhihui Lang Chadds Ford, PA More articles by this author , and Zvi CohenZvi Cohen Pointe Claire, Canada More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1800AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Intravesical chemotherapy is recognized as effective immediately after transurethral resection of bladder tumor (TURBT)/biopsy, whereas bacillus Calmette-Guerin (BCG) is contraindicated for ≤2 weeks postsurgery to allow for urothelial healing, due to risk of serious complications. Mycobacterial cell wall-DNA complex (MCC), derived from the nonpathogenic Mycobacterium phlei, exhibits a dual mechanism of action, with both direct chemotherapeutic effects and immunostimulatory effects. MCC is a sterile suspension which has been investigated in multiple clinical trials and shown to reduce non-muscle-invasive bladder cancer (NMIBC) recurrences after BCG failure. Phase III clinical trial data were analyzed to determine whether MCC could be safely instilled immediately after NMIBC-related surgery. METHODS Retrospective analysis identified patients who received their first MCC dose immediately postsurgery in a clinical trial in patients with BCG-refractory high-grade NMIBC. Patients received 6 weekly MCC instillations, followed by 3 once-weekly instillations at 3, 6, 12, 18, and 24 months. At their discretion, and considering their previous experience with MCC treatment, some investigators instilled MCC ≤1 day postsurgery. RESULTS 14% (18/129) of patients received MCC within 24 hours of surgery (32 instillations total); 12% (16/129) received MCC on the same day of surgery (28 instillations total). Adverse events (AEs) were experienced by 28% (5/18) of patients following 16% (5/32) of instillations (all in different patients and all when MCC was given on the day of surgery). In 4 of these 5 instillations, AEs consisted of hematuria, urinary frequency, dysuria, and suprapubic cramps. All were mild to moderate in severity and not considered treatment related. One patient experienced rigor, nausea, and headache with moderate severity after 1 instillation (possibly related to MCC). No AEs resulted in treatment discontinuation. 3 of the 5 patients received an instillation on the same day of surgery at another time without experiencing AEs. 39% (7/18) of the patients were disease free at 1 year. CONCLUSIONS MCC was well tolerated when instilled intravesically immediately after TURBT/biopsy in this group of patients. Further investigation is needed to determine if MCC, like cytotoxic agents, can be administered in the immediate postoperative setting to prevent reimplantation of circulating tumor cells and potentially impact the rate of recurrence. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byMorales A, Herr H, Steinberg G, Given R, Cohen Z, Amrhein J and Kamat A (2014) Efficacy and Safety of MCNA in Patients with Nonmuscle Invasive Bladder Cancer at High Risk for Recurrence and Progression after Failed Treatment with bacillus Calmette-GuérinJournal of Urology, VOL. 193, NO. 4, (1135-1143), Online publication date: 1-Apr-2015. Volume 187Issue 4SApril 2012Page: e719-e720 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alvaro Morales Kingston, Canada More articles by this author David Jablonski Orlando, FL More articles by this author Christine Lihou Chadds Ford, PA More articles by this author Zhihui Lang Chadds Ford, PA More articles by this author Zvi Cohen Pointe Claire, Canada More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...