A Pilot Study of Bevacizumab and Interferon-α2b in Ocular Melanoma:

Objectives: We hypothesized that administration of bevacizumab, a monoclonal antibody that neutralizes vascular endothelial growth factor, in combination with high-dose interferon-alpha2b (IFN-alpha 2b), an inhibitor of basic fibroblast growth factor, would have clinical activity in patients with metastatic ocular melanoma. Methods: Patients with metastatic ocular melanoma received bevacizumab (15 mg/kg intravenously every 2 weeks) plus IFN-alpha 2b (5 MU/m(2) subcutaneously 3 times weekly for 2 weeks followed by a dose of 10 MU/m(2) subcutaneously thereafter). Patients exhibiting a clinical response or stabilization of disease were treated until disease progression. Results: In this pilot study, 5 patients were treated (3 men, 2 women) with a mean age of 63.8 years (range, 53-71 years). Overall, the regimen was well-tolerated. The following adverse events were noted: grade 3 dyspnea (2 patients), grade 3 and 4 fatigue (2), grade 3 muscle weakness (1), grade 3 anorexia (1), grade 1 and 2 proteinuria (2), and grade 3 diarrhea (1). All adverse events resolved with a treatment holiday or dose reduction. One patient had reduction in tumor burden of 23% by Response Evaluation Criteria in Solid Tumors criteria and 2 patients had stabilization of disease lasting 28 and 36 weeks, respectively. Two patients failed to respond and progressed after 6 and 7 weeks of therapy. Conclusion: Bevacizumab and IFN-alpha 2b were well tolerated in this patient population, and clinical activity was observed. Further study of high-dose IFN-alpha 2b in combination with bevacizumab in this setting is warranted.