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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.

In: Annals of Oncology, 2012, vol. 23, no. 7, p. 1680-1687

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    Titre
    • 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
    Auteur
    • Reichardt, P.. HELIOS Klinikum Bad Saarow, Sarkomzentrum Berlin-Brandenburg, Bad Saarow, Germany
    • Blay, J.-Y. Léon Bérar Comprehensive Cancer Centre, Université Claude Bernard Lyon I, Lyon, France
    • Gelderblom, H.. Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands
    • Schlemmer, M.. Department of Internal Medicine III, University Hospitals Grosshadern, Ludwig Maximilians University Munich, Munich, Germany
    • Demetri, G. D.. Center for Sarcoma and Bone Oncology, Ludwig Center at Dana-Farber/Harvard Cancer Center, Dana-Farber Cancer Institute, Boston, USA
    • Bui-Nguyen, B.. Institut Bergonié, Bordeaux, France
    • McArthur, G. A.. Division of Cancer Medicine, Peter MacCallum Cancer Center, Melbourne, Australia
    • Yazji, S.. Novartis Pharmaceuticals Corporation, Florham Park, USA
    • Hsu, Y.. Novartis Pharmaceuticals Corporation, Florham Park, USA
    • Galetic, I.. Novartis Pharma AG, Basel, Switzerland
    • Rutkowski, P.. Department of Soft Tissue/Bone Sarcoma and Melanoma, M. Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2012, vol. 23, no. 7, p. 1680-1687. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:303589
    Summary
    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