Objectives: T1G3 superficial bladder cancer is considered to be at high risk for progression, and in some institutions early cystectomy is advocated. Other authors and personal experience suggest that conservative treatment, such as TURBT followed by intravesical prophylaxis, may be adequate in the majority of cases. The purpose of the present phase II study was to assess the tolerability and efficacy of sequential intravesical administration of a chemotherapeutic agent, epirubicin, followed by BCG, after TURBT.
Materials and methods: 81 patients with primary T1G3 superficial bladder cancer, without evidence of Tis or upper tract tumor, underwent TURBT and intravesical prophylaxis with weekly epirubicin 50 mg for 8 weeks followed by weekly BCG Connaught 120 mg for 6 weeks. A control cystoscopy with bladder mapping and/or TUR of suspicious areas was performed at 15-17 weeks. Then patients were followed-up with 3-month urinary cytology and cystoscopy.
Results: The sequential chemo-immunoprophylaxis was generally well tolerated. After a mean follow-up of 48 months recurrent tumors were found in 19 patients (23.4%) and progressive disease in 6 cases (7.4%). Of 6 progressions, 4 patients died (5%) of the disease.
Conclusion: Sequential chemo-immunoprophylaxis with epirubicin followed by BCG is well tolerated and seems to be efficacious in primary T1G3 bladder cancer. The recurrence progression and disease-specific mortality rates were acceptable so that this study seems to confirm previous data which show that TURBT and intravesical prophylaxis are appropriate treatment for the majority T1G3 tumors.