Low-dose thalidomide and interferon alpha-2b in patients with metastatic melanoma: The final results of a pilot study

Abstract

7571 Background Melanoma is a hypervascular tumor and angiogenesis plays a critical role in the development/progression of metastases. Since various pathways are involved in tumor angiogenesis, a combination of agents with different anti-angiogenesis activities is a reasonable approach. Methods Patients with stage IV melanoma who failed first-line treatments were treated with a combination of thalidomide [Celgene, Warren, NJ] (200 mg/day, p.o.) and interferon alpha-2b (3 MIU, 3x/week, s.c.). Patients were evaluated monthly for toxicity and every 2 months for clinical response. Stabilization or regression of metastases was the primary endpoint of the study. Overall survival (OS), progression free survival (PFS), time to progression (TTP) and toxicity were also evaluated as secondary endpoints. Results Fifteen patients were enrolled: 9 cutaneous, 6 uveal melanoma; 10 males, 5 females; median age, 56.7 years (42–70). One patient with adrenal, mediastinal and skin metastases achieved partial response (PR), 3 patients achieved stable disease (SD), and 9 patients progressed. Two patients were not evaluable due to discontinuation of treatment prior to initial evaluation for response at 2 month (neurotoxicity, n=1; withdrawal of consent, n=1). The overall response rates (PR+SD) of “intent to treat” patients and evaluable patients were 26.7% and 30.8%, respectively. TTP was 8 months for the patient with PR, and 4, 5.5 and 12 months for 3 patients with SD. With the median follow-up of 22.8 months (12–32 months), the median OS and PFS of “intent to treat” patients were 4.2 months (1–32 months) and 3.4 months (0.5–14 months), respectively. Grade 3 toxicities related to treatment included neutropenia (n=5), elevation of transaminases (n=2), and neuropathy (n=1). No treatment-related deaths were experienced. Conclusions These preliminary results suggest that combination treatment with thalidomide and interferon alpha would be an effective palliative treatment for previously treated, stage IV melanoma patients. No significant financial relationships to disclose.