Single instillation of mitomycin C plus bacillus Calmette-Guérin (BCG) versus BCG alone in high grade non-muscle invasive bladder cancer.

INTRODUCTION: This study sought to determine if the addition of perioperative mitomycin C (MMC) to treatment with bacillus Calmette-Guérin (BCG) after transurethral resection (TURBT) is superior to TURBT plus BCG alone in high grade non-muscle invasive bladder cancer (NMIBC).

MATERIALS AND METHODS: Data for 719 patients diagnosed with NMIBC at the University of Pennsylvania Health System between 1977 and 2009 was reviewed retrospectively. Of these patients, 120 had high grade disease and were treated with either BCG alone or with a single instillation of 40 mg of MMC perioperatively in addition to BCG and were thus included in our study. The primary endpoints of this study included recurrence-free survival, overall and disease-free survival as assessed via Kaplan-Meier analysis.

RESULTS: Of the 120 patients identified who received treatment for high grade NMIBC, 97 were treated with BCG alone and 23 received a single instillation of perioperative MMC in addition to BCG. There were no statistically significant differences noted in demographic or pathologic variables. Patients were followed for a median of 4.5 years and a maximum of 21.8 years, with no differences demonstrated in recurrence-free survival (p = 0.75), overall survival (p = 0.93) or disease-free survival (p = 0.76). Both lack of lymphovascular invasion and BCG maintenance therapy reached significance as independent predictors of recurrence-free survival (p = 0.19 and p = 0.28).

CONCLUSIONS: While our study indicates that perioperative MMC likely offers little benefit in regards to recurrence or survival in high grade NMIBC, at this point in time, a larger scale, randomized, controlled trial is needed to adequately address this question.