Introduction and Objectives: Intravesical chemotherapy is recognized aseffective immediately after transurethral resection of bladder tumor/biopsy,whereas bacillus Calmette-Guérin (BCG) is contraindicated for ≤2 weekspostsurgery. Mycobacterial cell wall-DNA complex (MCC), exhibits a dualmechanism of action (chemotherapeutic and immunostimulatory effects)and shown to reduce non-muscle-invasive bladder cancer (NMIBC) recurrencesafter BCG failure. Clinical trial data in patients with BCG-refractoryNMIBC were analyzed to determine whether MCC could be safely instilledimmediately postsurgery.Methods: Retrospective analysis identified patients who received an MCCdose immediately postsurgery. Patients received 6 weekly MCC instillations,followed by 3 instillations at 3, 6, 12, 18, and 24 months. At their discretion,some investigators instilled MCC ≤1 day postsurgery.Results: 18 of 129 patients (14%) received a total of 32 instillations ofMCC within one day of surgery. Adverse events (AEs) were experiencedby 28% (5/18) of patients following 16% (5/32) of instillations (all in differentpatients and when MCC given on the day of surgery). In 4 of these5 instillations, AEs consisted of hematuria, urinary frequency, dysuria, andsuprapubic cramps. All were mild to moderate in severity and not treatmentrelated. 1 patient experienced rigor, nausea, and headache with moderateseverity after 1 instillation (possibly related to MCC). No AEs resulted intreatment discontinuation. 3 of the 5 patients received an instillation onthe 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 immediatelypostsurgery in this group of patients. Further investigation is neededto determine if MCC can be administered in the immediate postoperativesetting to prevent reimplantation of circulating tumor cells and potentiallyimpact the rate of recurrence.
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