Biomarker Analysis in a Phase II Study of Sunitinib in Patients with Advanced Melanoma.

Aim: To investigate the efficacy of sunitinib in patients with advanced melanoma and to correlate angiogenic biomarkers with response and survival.

Patients And Methods: We performed a phase II study in patients with advanced pre-treated melanoma. The primary endpoint was tumor response. Blood samples for biomarker analysis including vascular endothelial growth factor (VEGF), and its receptors VEGFR1 and -2, placental growth factor (PlGF) and circulating endothelial cells (CEC) were collected at baseline and during the first cycle.

Results: Four out of 39 patients (13%) achieved a partial response and eight (26%) stable disease. Time to progression was at least six months in seven patients. High baseline VEGFR1 levels and high baseline PlGF levels were both associated with a non-significant worse survival (p=0.08 for both).

Conclusion: Sunitinib demonstrates limited activity in unselected patients with refractory advanced melanoma, but a minority of patients experienced long-term disease control. Identification of these patients remains a challenge.