Sorafenib in metastatic uveal melanoma : A multicentric prospective phase II study

Abstract

Purpose: Uveal melanoma is the most common primary ocular malignancy in adults, accounting for 70 % of all eye malignancy. Despite adequate local treatment, about 30-50 % of patients develop metastasis and the survival rate is 50% after 10 years and the median survival time is 5-7 months after development of metastasis. There is no consensual and effective treatment in metastatic uveal melanoma. Preclinical data suggest that Sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis may be a potential treatment of metastatic uveal melanoma. The primary objective of this study was the non-progression rate at 6 months with 800 mg/day of Sorafenib in patient with metastatic uveal melanoma.

Methods: Multicenter, non-comparative, non-randomized, phase II study was conducted. The primary objective was to determine the non-progression rate at 6 months for patients receiving Sorafenib at dose of 400 mg twice per day orally according the RECIST criteria. Quality of Life and adverse events were evaluated. Secondary efficacy endpoints included progression-free survival, overall survival, quality of life and adverse events

Results: 32 patients were enrolled in this study and 29 patients were evaluable. Non-progression at 6 months was observed in 11 patients (38%). Non-progression at 12 months was observed in 4 patients (13%). The overall survival was 10 months. Fatigue was a frequent adverse event and limited the quality of life.

Conclusions: Sorafenib at dose of 400 mg twice per day orally showed non-progression rate at 6 months in some patients with metastatic uveal melanoma