PURPOSE: We attempted to prove if alternating chemoprophylactic and immunoprophylactic instillations improved efficacy and decreased toxicity in patients with recurrent superficial bladder cancer. MATERIALS AND METHODS: A total of 188 patients with rapidly recurring stage Ta or T1 cancer was randomly treated with mitomycin C (group 1) or alternating mitomycin C and Pasteurstrain bacillusCalmette-Guerin (BCG) instillations (group 2) for 2 years. Mean followup was 34 months. RESULTS:Median times to initial recurrence were 12 months in group 1 and 7 months in group 2 (p = 0.976), and treatment failed in 21.5% and 18.9%, respectively. Recurrence rates during the instillation period were 1.01 in group 1 and 0.86 in group 2 (p = 0.376). There was no difference in the disease-free interval between the 2 groups (p = 0.976). Instillations were discontinued because of adverse effects in 6 cases (6%) in both groups. CONCLUSIONS: Efficacy of alternating mitomycin C and BCG was equal to mitomycin C monotherapy, and both methods were effective in prophylaxis of recurrent papillary bladder cancer. Less toxicity occurred in the alternating treatment group compared to earlier BCG monotherapy results.
RCT Entities:
PURPOSE: We attempted to prove if alternating chemoprophylactic and immunoprophylactic instillations improved efficacy and decreased toxicity in patients with recurrent superficial bladder cancer. MATERIALS AND METHODS: A total of 188 patients with rapidly recurring stage Ta or T1 cancer was randomly treated with mitomycin C (group 1) or alternating mitomycin C and Pasteur strain bacillus Calmette-Guerin (BCG) instillations (group 2) for 2 years. Mean followup was 34 months. RESULTS: Median times to initial recurrence were 12 months in group 1 and 7 months in group 2 (p = 0.976), and treatment failed in 21.5% and 18.9%, respectively. Recurrence rates during the instillation period were 1.01 in group 1 and 0.86 in group 2 (p = 0.376). There was no difference in the disease-free interval between the 2 groups (p = 0.976). Instillations were discontinued because of adverse effects in 6 cases (6%) in both groups. CONCLUSIONS: Efficacy of alternating mitomycin C and BCG was equal to mitomycin C monotherapy, and both methods were effective in prophylaxis of recurrent papillary bladder cancer. Less toxicity occurred in the alternating treatment group compared to earlier BCG monotherapy results.
Authors: Maha H A Hussain; David P Wood; Dean F Bajorin; Bernard H Bochner; Robert Dreicer; Donald L Lamm; Michael A O'Donnell; Arlene O Siefker-Radtke; Dan Theodorescu; Colin P Dinney Journal: J Clin Oncol Date: 2009-10-26 Impact factor: 44.544
Authors: Stefanie Schmidt; Frank Kunath; Bernadette Coles; Desiree Louise Draeger; Laura-Maria Krabbe; Rick Dersch; Samuel Kilian; Katrin Jensen; Philipp Dahm; Joerg J Meerpohl Journal: Cochrane Database Syst Rev Date: 2020-01-08