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

摘要

OBJECTIVE: * To evaluate the efficacy and toxicity of the combination of bacillus Calmette-Guerin (BCG) and interferon alpha-2B (IFNalpha-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 IFNalpha-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 IFNalpha-2B in the patient population with SBC has similar efficacy and toxicity to BCG monotherapy.