A study to compare the efficacy and local toxicity of combining anticancer drugs immunotherapy and chemotherapy (Sequential BCG and mitomycin c) versus mitomycin alone in the treatment of superficial bladder cancer after complete transurethral resection.
The study was designed as a prospective study done in Al-hussain Teaching Hospital in Thiqar from July 2007 to August 2010. After transurethral resection and multiple biopsies, eighty-three patients (62m, 21f) from 38-75 years old, suffering from primary superficial (Ta-T1) TCC of the bladder, were randomly assigned to receive intravesical instillations of Mitomycin C (MMC) alone for 41 patients, and the sequential BCG and Mitomycin c, for 42 patients (81 mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg Mitomycin c once a week for four weeks.
The patients evaluated for complications and recurrence and progression rate, they have follow up cystoscope every 3 months for the 1st year then every 6 months for the 2nd year and then yearly . Mean follow-up time was 36 months. The main object of the study were evaluation of recurrence and progression rate and estimate the safety with evaluation of subjective and objective side effects and clinical complications.
Of the 83 randomly assigned patients, the analysis demonstrated a significant statistical difference in the recurrence rate. Patients assigned sequential BCG and Mitomycin c had lower recurrence rate 16.6 % (7 patients) versus 29.2% (12 patients) in those assigned for Mitomycin c alone, the difference between groups 12.6%; The progression rate in patients assigned sequential BCG and Mitomycin c about 7 % (3 patients) versus 17 % (7 patients) in those assigned for Mitomycin c alone, the difference between groups 10%. However the side-effects were mainly localized to the bladder, the complications after the treatment more common in patients receive sequential BCG and Mitomycin c than in those receive Mitomycin c alone.
Cystitis occur in about 35 patients (83%) in those receiving sequential BCG and Mitomycin c, and two patient 4.7 % developed fever and chills. While in patients receive Mitomycin alone the complications were less cystitis in 4 patients 10%, rash in about 3 patients (7%) and myelosuppression two patients 5%.
Conclusion: In this series, sequential BCG and Mitomycin c appears to be more effective than Mitomycin c alone in the treatment of superficial bladder tumors at 36-month follow-up, despite an increased but acceptable local toxicity.This probably because the BCG-induced inflammation might increase the permeability of the bladder mucosa such that Mitomycin c can reach the target tissue more easily and exert its anticancer effect.