Serveur d'exploration sur les relations entre la France et l'Australie

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Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg

Identifieur interne : 00A513 ( Main/Exploration ); précédent : 00A512; suivant : 00A514

Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg

Auteurs : John R. Zalcberg [Australie] ; Jaap Verweij [Pays-Bas] ; Paolo G. Casali [Italie] ; Axel Le Cesne [France] ; Peter Reichardt [Allemagne] ; Jean-Yves Blay [France] ; Marcus Schlemmer [Allemagne] ; Martine Van Glabbeke [Belgique] ; Michelle Brown [Belgique] ; Ian R. Judson [Royaume-Uni]

Source :

RBID : Pascal:05-0400757

Descripteurs français

English descriptors

Abstract

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.


Affiliations:


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Le document en format XML

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<term>Antineoplastic agent</term>
<term>Cancerology</term>
<term>Crossing over</term>
<term>Daily dose</term>
<term>Enzyme inhibitor</term>
<term>Gastrointestinal stromal tumor</term>
<term>Gut</term>
<term>Human</term>
<term>Imatinib</term>
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<term>Imatinib</term>
<term>Pronostic</term>
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<term>Crossing over</term>
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<term>Inhibiteur enzyme</term>
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<term>Tumeur stromale gastrointestinale</term>
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<div type="abstract" xml:lang="en">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.</div>
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