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Phase III study of nilotinib versus best supportive care with or without a TKI in patients with gastrointestinal stromal tumors resistant to or intolerant of imatinib and sunitinib.
Reichardt, P; Blay, J-Y; Gelderblom, H; Schlemmer, M; Demetri, G D; Bui-Nguyen, B; McArthur, G A; Yazji, S; Hsu, Y; Galetic, I; Rutkowski, P.
Afiliación
  • Reichardt P; HELIOS Klinikum Bad Saarow, Sarkomzentrum Berlin-Brandenburg, Bad Saarow, Germany. peter.reichardt@helios-kliniken.de
Ann Oncol ; 23(7): 1680-7, 2012 Jul.
Article en En | MEDLINE | ID: mdl-22357255
BACKGROUND: This phase III open-label trial investigated the efficacy of nilotinib in patients with advanced gastrointestinal stromal tumors following prior imatinib and sunitinib failure. PATIENTS AND METHODS: Patients were randomized 2:1 to nilotinib 400 mg b.i.d. or best supportive care (BSC; BSC without tyrosine kinase inhibitor, BSC+imatinib, or BSC+sunitinib). Primary efficacy end point was progression-free survival (PFS) based on blinded central radiology review (CRR). Patients progressing on BSC could cross over to nilotinib. RESULTS: Two hundred and forty-eight patients enrolled. Median PFS was similar between arms (nilotinib 109 days, BSC 111 days; P=0.56). Local investigator-based intent-to-treat (ITT) analysis showed a significantly longer median PFS with nilotinib (119 versus 70 days; P=0.0007). A trend in longer median overall survival (OS) was noted with nilotinib (332 versus 280 days; P=0.29). Post hoc subset analyses in patients with progression and only one prior regimen each of imatinib and sunitinib revealed a significant difference in median OS of >4 months in favor of nilotinib (405 versus 280 days; P=0.02). Nilotinib was well tolerated. CONCLUSION: In the ITT analysis, no significant difference in PFS was observed between treatment arms based on CRR. In the post hoc subset analyses, nilotinib provided significantly longer median OS.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperazinas / Pirimidinas / Pirroles / Tumores del Estroma Gastrointestinal / Inhibidores de Proteínas Quinasas / Neoplasias Gastrointestinales / Indoles / Antineoplásicos Tipo de estudio: Clinical_trials Límite: Aged80 Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2012 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperazinas / Pirimidinas / Pirroles / Tumores del Estroma Gastrointestinal / Inhibidores de Proteínas Quinasas / Neoplasias Gastrointestinales / Indoles / Antineoplásicos Tipo de estudio: Clinical_trials Límite: Aged80 Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2012 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido