Anticancer research · 2015
Biomarker Analysis in a Phase II Study of Sunitinib in Patients with Advanced Melanoma.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Decoster Lore, Vande Broek Isabelle, Neyns Bart, Majois Françoise, Baurain Jean François, Rottey Sylvie, Rorive Andrée, Anckaert Ellen, De Mey Johan, De Brakeleer Sylvia, De Grève Jacques
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorEndothelial CellsEndpoint DeterminationFemaleHumansIndolesMaleMelanomaMiddle AgedMutationNeovascularization, PathologicPlacenta Growth FactorPregnancy ProteinsProto-Oncogene Proteins c-kitPyrrolesSkin NeoplasmsSunitinibSurvival AnalysisVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-1Vascular Endothelial Growth Factor Receptor-2