Zalcberg, J. R., Verweij, J., Casali, P. G., Le Cesne, A., Reichardt, P., Blay, J. Y., Schlemmer, M., Van Glabbeke, M., Brown, M., Judson, I. R. (2005) Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg. EUROPEAN JOURNAL OF CANCER, 41 (12). pp. 1751-1757. ISSN 0959-8049

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Abstract

Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg In the EORTC-ISG-AGITG trial 946 patients with advanced gastro-intestinal stromal tumours (GIST) were randomised to receive 400 or 800 mg of imatinib daily. An increase in progression free survival (PFS) was demonstrated for patients randomised to the high-dose arm. Patients randomised to low-dose could cross-over to high-dose upon progression. We evaluated the feasibility, safety and efficacy of this policy. Of the 241 patients available for follow-up, 133 patients (55%) crossed over to high-dose imatinib according to the protocol. Of these patients, 92% had not had a prior dose reduction. The cumulative incidence of subsequent dose reductions after cross-over was 17% after six months with 51% discontinuing therapy without requiring a dose reduction. The extent of anaemia and fatigue increased significantly after cross-over, whilst neutropenia was less severe than during low-dose treatment. Objective responses after cross-over included three patients (2%) with a partial response and 36 (27%) with stable disease. The median PFS after cross-over was 81 days, although 18.1% of patients were still alive and progression free one year after cross-over. We conclude that a cross-over to high-dose imatinib is feasible and safe in GIST patients who progress on low-dose therapy. (C) 2005 Elsevier Ltd. All rights reserved.

Item Type:	Article
Authors (ICR Faculty only):	Judson, Ian
All Authors:	Zalcberg, J. R., Verweij, J., Casali, P. G., Le Cesne, A., Reichardt, P., Blay, J. Y., Schlemmer, M., Van Glabbeke, M., Brown, M., Judson, I. R.
Uncontrolled Keywords:	imatinib; GIST; dose effects; progression Anticancer agents; phase-ii; trial; efficacy; mesylate; safety
Research teams:	Clinical Units > Sarcoma Unit ICR divisions > Cancer Therapeutics > Signal Transduction & Molecular Pharmacology
Depositing User:	EPrints Services
Date Deposited:	10 Aug 2007 20:52
Last Modified:	23 Apr 2015 15:12
URI:	http://publications.icr.ac.uk/id/eprint/2299

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