Comparative study of sequential intravesical chemotherapy using gemcitabine and mitomycin C with mitomycin C alone for non-muscle invasive bladder carcinoma- a randomized trial

Abstract

Background: This comparative study conducted to know the efficacy and safety of intravesical gemcitabine and mitomycinC with mitomycinC alone in refractory bladder cancer. Methods: A total of 219 patients with non-muscle invasive recurrent bladder cancer refractory to BCG therapy, were enrolled at tertiary centres b/w Feb 2009-Jan 2011 with f/u for 3 yrs. After documenting the tumor size and location on cystoscopy they were randomly assigned into: Gentamycin & mitomycin (group A), mitomycin (group B). They were given intravesical chemotherapy (2 g gemcitabine f/b 40 mg mitomycin) weekly for 6 weeks and in second group mitomycin alone was given for 6weeks f/b maintenance therapy monthly for next 1 year. F/u done by cystoscopy. Results: Of total of 219 patients fifteen not meeting inclusion criteria &four denied. So 98 in Gp A & 96 in Gp B completed the therapy. In group A i.e Gentamycin & MMC a total, 82 patients (83.67%) exhibited a complete response. Rest 16 (16.23%) patients exhibited partial response. These patients had biopsy proven recurrence within 22 ± 6.16 months months. Of the 96 evaluated patients in group MMC, 63 (65.60%) exhibited a complete response while 22 patients (22.9%) had partial response, 1 patient expired due to cor pulmonale. During follow-up, 16 patients (25.3%) developed recurrence, whereas the remaining patients 47 (48.9%) were recurrence-free within this period. Median time to recurrence seen in this group was 14.5 ± 8.26 months. Conclusions: Chemoresection with sequential intravesical gemcitabine and mitomycin C is better that mitomycin alone in refractory cases. (Table Presented ).