Ghazaleh Ghandchi - Pediatric Infections Research Center, Research Institute for Children Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Mahdi Fallah - Azad Medical University, Tehran, Iran
Sadat Sajadi Nia - Shahid Beheshti University of Medical Sciences, Tehran, Iran

Background: The efficacy of intravesical thiotepa was evaluated compared with administration of Bacille Calmette-Guérin (BCG) in non-muscle invasive bladder cancer.Methods: The efficacy of intravesical thiotepa was evaluated compared with administration of Bacille Calmette-Guérin (BCG) in non-muscle invasive bladder cancer.Methods: In this multicenter, prospective, randomized study, eligible patients were those with proven non-muscle invasive bladder cancer. All patients were randomly allocated to Group A, receiving intravesical thiotepa (at a dose of 30 mg/30 ml) once weekly for 9 consecutive weeks and then monthly for 12 months or Group B, receiving intravesical Bacille Calmette-Guérin (Connaught strain, 80 mg/50 ml) over a 9-week induction course and each week for 3 weeks at 3, 6 and 12 months. Outcome measures were recurrence rate, time to first recurrence and progression rate. Treatment-related complications were also evaluated. In this multicenter, prospective, randomized study, eligible patients were those with proven non-muscle invasive bladder cancer. All patients were randomly allocated to Group A, receiving intravesical thiotepa (at a dose of 30 mg/30 ml) once weekly for 9 consecutive weeks and then monthly for 12 months or Group B, receiving intravesical Bacille Calmette-Guérin (Connaught strain, 80 mg/50 ml) over a 9-week induction course and each week for 3 weeks at 3, 6 and 12 months. Outcome measures were recurrence rate, time to first recurrence and progression rate. Treatment-related complications were also evaluated. Results: Seventy-two participants were enrolled, 36 for each group, 17 in Group A developed disease recurrence versus 25 of those in Group B (p < 0.05). There was no statistically significant difference in mean time to the first recurrence (Group A, 4.2 months; Group B, 4.1 months; p > 0.05). Seven of 17 (41%) patients in Group A and 16 of 25 (64%) patients in Group B had disease progression and underwent radical cystectomy (p < 0.05). Both intravesical administrations were generally well tolerated. Seventy-two participants were enrolled, 36 for each group, 17 in Group A developed disease recurrence versus 25 of those in Group B (p < 0.05). There was no statistically significant difference in mean time to the first recurrence (Group A, 4.2 months; Group B, 4.1 months; p > 0.05). Seven of 17 (41%) patients in Group A and 16 of 25 (64%) patients in Group B had disease progression and underwent radical cystectomy (p < 0.05). Both intravesical administrations were generally well tolerated. Conclusion: Thiotepa is a promising intravesical agent for treatment of non-muscle invasive bladder cancer.

Bacille Calmette-Guérin, Intravesical administration, Non-muscle invasive bladder cancer, Thiotepa