Co-administration of intravesical bacillus Calmette-Guerin and interferon α-2B as first line in treating superficial transitional cell carcinoma of the urinary bladder

OBJECTIVE To evaluate the efficacy and toxicity of the combination of bacillus Calmette-Guerin (BCG) and interferon alpha-2B (IFN alpha-2B) in treating superficial bladder cancer (SBC). The mentioned combination has shown synergism in pre-clinical studies. PATIENTS AND METHODS The present study is a single-arm, open-label, single-institution prospective trial. Patients with Ta, T1 or in situ carcinoma and no previous intravesical therapy were included between July 2002 and June 2009. Patients were treated with weekly intravesical instillation of 27 mg of BCG mixed with 10 million units (MU) of IFN alpha-2B for six consecutive weeks followed by 3-weekly booster instillations at 3 months if there was no recurrence. The primary endpoint was disease recurrence. Secondary endpoints were disease progression and toxicity. Patients were followed-up with cystoscopy and urine cytology every 3 months. RESULTS In all, 50 patients were included. At a median follow-up of 55.8 months, 31 (62%) patients were recurrence-free. Progression to muscle invasion occurred in two (4%) and metastasis occurred in two (4%) patients. Treatment was well tolerated, with grade III dysuria and frequency occurring in 18 and 14% of patients, respectively, and with 74% of patients being able to complete the maintenance dosage. CONCLUSION The combination of BCG and IFN alpha-2B in the patient population with SBC has similar efficacy and toxicity to BCG monotherapy.