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Thiotepa versus Bacille Calmette-Guérin in Non-Muscle Invasive Bladder Cancer
Fatemeh Fallah1, Mahdi Fallah2, Raheleh Sadat Sajadi Nia1
1Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Objective:
The efficacy of intravesical thiotepa was evaluated compared with administration of Bacille Calmette-Guérin (BCG) in non-muscle invasive bladder cancer.
Patients:
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.
Conclusion:
Thiotepa is a promising intravesical agent for treatment of non-muscle invasive bladder cancer.
