Bacillus calmette-Guérin plus intravesical interferon alpha-2b in patients with superficial bladder cancer

Bacillus Calmette-Guérin (BCG) and interferon alpha-2b (IFN α2b) have been used individually for the treatment of bladder cancer. We used a low dose of BCG combined with IFN α2b to determine the safety and to assess the efficacy of this combination therapy. A study of 12 patients with superficial bladder cancer evaluated the safety and efficacy of a combination of low-dose BCG and IFN α2b, given weekly for 6 weeks. Three patients were assigned to each of four groups in which 60 mg of BCG was combined with 10, 30, 60, or 100 × 10 6 ILJ of IFN α2b. The combination BCG/IFN α2b therapy was well tolerated, with adverse effects being mild to moderate and resolved at the end of treatment. At 12 months post-treatment there has been no tumor progression. Two patients with previous multifocal transitional cell carcinoma have had solitary recurrences. One patient has had recurrent carcinoma in situ. This preliminary study found combination BCG/IFN α2b induction therapy to be safe and well tolerated. These early results show a high response rate, but efficacy can only be determined with Phase II and III studies.