AustralieFrV1, PascalFrancis, Curation, bibRecord, 001925

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 : 001925 ( PascalFrancis/Curation ); précédent : 001924; suivant : 001926

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 :

European journal of cancer : (1990) [ 0959-8049 ] ; 2005.

RBID : Pascal:05-0400757

Descripteurs français

Pascal (Inist)
- Imatinib, Pronostic, Homme, Intestin, Stroma, Crossing over, Dose journalière, Protein-tyrosine kinase, Inhibiteur enzyme, Cancérologie, Pharmacologie, Anticancéreux, Tumeur stromale gastrointestinale.
Wicri :
- topic : Homme, Pharmacologie.

English descriptors

KwdEn :
- Antineoplastic agent, Cancerology, Crossing over, Daily dose, Enzyme inhibitor, Gastrointestinal stromal tumor, Gut, Human, Imatinib, Pharmacology, Prognosis, Protein-tyrosine kinase, Stroma.

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.

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C01	`01`		`ENG`	@0 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.
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Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><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>
<term>Pharmacology</term>
<term>Prognosis</term>
<term>Protein-tyrosine kinase</term>
<term>Stroma</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Imatinib</term>
<term>Pronostic</term>
<term>Homme</term>
<term>Intestin</term>
<term>Stroma</term>
<term>Crossing over</term>
<term>Dose journalière</term>
<term>Protein-tyrosine kinase</term>
<term>Inhibiteur enzyme</term>
<term>Cancérologie</term>
<term>Pharmacologie</term>
<term>Anticancéreux</term>
<term>Tumeur stromale gastrointestinale</term>
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<front><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>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0959-8049</s0>
</fA01>
<fA03 i2="1"><s0>Eur. j. cancer : (1990)</s0>
</fA03>
<fA05><s2>41</s2>
</fA05>
<fA06><s2>12</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>ZALCBERG (John R.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>VERWEIJ (Jaap)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>CASALI (Paolo G.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>LE CESNE (Axel)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>REICHARDT (Peter)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>BLAY (Jean-Yves)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>SCHLEMMER (Marcus)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>VAN GLABBEKE (Martine)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>BROWN (Michelle)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>JUDSON (Ian R.)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Medical Oncology, Division of Haematology and Medical Oncology, Peter MacCullum Cancer Centre, Locked Bag 1, A'Beckett Street</s1>
<s2>Melbourne, Vic. 8006</s2>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Medical Oncology, Erasmus Medical Centre</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Medical Oncology, Istituto per lo Studio e la Cura die Tumori</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Department of Medical Oncology, Institut Guslare Roussy</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Haematology, Oncology and Tumorimmunology, HELlOS-Klinikum, Charité, Robert -Roessle -Klinik</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Department of Medical Oncology, Hopilal E. Herriot & Centre L. Berard</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Department of Medical Oncology, Klinikum Grosshadern</s1>
<s2>Munich</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>KKG Hyperthermie, GSF National Research Centre for Environment and Health</s1>
<s2>Munich</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>EORTC Data Centre</s1>
<s2>Brussels</s2>
<s3>BEL</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Sarcoma Unit, Royal Marsden Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>EORTC Soft Tissue and Bone Sarcoma Group</s1>
<s3>ITA</s3>
</fA17>
<fA17 i1="02" i2="1"><s1>Italian Sarcoma Group</s1>
<s3>ITA</s3>
</fA17>
<fA17 i1="03" i2="1"><s1>Australasian Gastrointestinal Trials Group</s1>
<s3>AUS</s3>
</fA17>
<fA20><s1>1751-1757</s1>
</fA20>
<fA21><s1>2005</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>12648</s2>
<s5>354000138637670130</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2005 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>14 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>05-0400757</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>European journal of cancer : (1990)</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Imatinib</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Imatinib</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Imatinib</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Pronostic</s0>
<s5>02</s5>
</fC03>
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<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Pronóstico</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Homme</s0>
<s5>03</s5>
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<fC03 i1="03" i2="X" l="ENG"><s0>Human</s0>
<s5>03</s5>
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<fC03 i1="03" i2="X" l="SPA"><s0>Hombre</s0>
<s5>03</s5>
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<fC03 i1="04" i2="X" l="FRE"><s0>Intestin</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Gut</s0>
<s5>05</s5>
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<fC03 i1="04" i2="X" l="SPA"><s0>Intestino</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Stroma</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Stroma</s0>
<s5>06</s5>
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<fC03 i1="05" i2="X" l="SPA"><s0>Estroma</s0>
<s5>06</s5>
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<fC03 i1="06" i2="X" l="FRE"><s0>Crossing over</s0>
<s5>08</s5>
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<fC03 i1="06" i2="X" l="ENG"><s0>Crossing over</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Cruce intercromosómico</s0>
<s5>08</s5>
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<fC03 i1="07" i2="X" l="FRE"><s0>Dose journalière</s0>
<s5>09</s5>
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<fC03 i1="07" i2="X" l="ENG"><s0>Daily dose</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Dosis diaria</s0>
<s5>09</s5>
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<fC03 i1="08" i2="X" l="FRE"><s0>Protein-tyrosine kinase</s0>
<s2>FE</s2>
<s5>11</s5>
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<fC03 i1="08" i2="X" l="ENG"><s0>Protein-tyrosine kinase</s0>
<s2>FE</s2>
<s5>11</s5>
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<fC03 i1="08" i2="X" l="SPA"><s0>Protein-tyrosine kinase</s0>
<s2>FE</s2>
<s5>11</s5>
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<fC03 i1="09" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0>
<s5>12</s5>
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<fC03 i1="09" i2="X" l="ENG"><s0>Enzyme inhibitor</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Inhibidor enzima</s0>
<s5>12</s5>
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<fC03 i1="10" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>17</s5>
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<fC03 i1="10" i2="X" l="ENG"><s0>Cancerology</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Pharmacologie</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Pharmacology</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Farmacología</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>25</s5>
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<fC03 i1="13" i2="X" l="FRE"><s0>Tumeur stromale gastrointestinale</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Gastrointestinal stromal tumor</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Tumor estromal gastrointestinal</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
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<fC07 i1="02" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
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<fC07 i1="03" i2="X" l="FRE"><s0>Appareil digestif</s0>
<s5>37</s5>
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<fC07 i1="03" i2="X" l="ENG"><s0>Digestive system</s0>
<s5>37</s5>
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<fC07 i1="03" i2="X" l="SPA"><s0>Aparato digestivo</s0>
<s5>37</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Appareil digestif pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Digestive diseases</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Aparato digestivo patología</s0>
<s5>38</s5>
</fC07>
<fN21><s1>276</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
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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

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

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