Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
9905692 | European Journal of Cancer | 2005 | 7 Pages |
Abstract
In the EORTC-ISG-AGITG trial 946 patients with advanced gastro-intestinal stromal tumours (GIST) were randomised to receive 400 or 800Â 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.
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Authors
John R. Zalcberg, Jaap Verweij, Paolo G. Casali, Axel Le Cesne, Peter Reichardt, Jean-Yves Blay, Marcus Schlemmer, Martine Van Glabbeke, Michelle Brown, Ian R. Judson, for the EORTC Soft Tissue and Bone Sarcoma Group,