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Predictive Factors for the Benefit of Perioperative FOLFOX for Resectable Liver Metastasis in Colorectal Cancer Patients (EORTC Intergroup Trial 40983)

Identifieur interne : 004A99 ( PascalFrancis/Curation ); précédent : 004A98; suivant : 004B00

Predictive Factors for the Benefit of Perioperative FOLFOX for Resectable Liver Metastasis in Colorectal Cancer Patients (EORTC Intergroup Trial 40983)

Auteurs : Halfdan Sorbye [Norvège] ; Murielle Mauer [Belgique] ; Thomas Gruenberger [Autriche] ; Bengt Glimelius [Suède] ; Graeme J. Poston [Royaume-Uni] ; Peter M. Schlag [Allemagne] ; Philippe Rougier [France] ; Wolf O. Bechstein [Allemagne] ; John N. Primrose [Royaume-Uni] ; Euan T. Walpole [Australie] ; Meg Finch-Jones [Royaume-Uni] ; Daniel Jaeck [France] ; Darius Mirza [Royaume-Uni] ; Rowan W. Parks [Royaume-Uni] ; Laurence Collette [Belgique] ; Eric Van Cutsem [Belgique] ; Werner Scheithauer ; Manfred P. Lutz [Allemagne] ; Bernard Nordlinger [France]

Source :

RBID : Pascal:12-0199128

Descripteurs français

English descriptors

Abstract

Objective: In EORTC study 40983, perioperative FOLFOX increased progression-free survival (PFS) compared with surgery alone for patients with initially 1 to 4 resectable liver metastases from colorectal cancer (CRC). We conducted an exploratory retrospective analysis to identify baseline factors possibly predictive for a benefit of perioperative FOLFOX on PFS. Methods: The analysis was based on 237 events from 342 eligible patients. Cox proportional hazards regression models with a significance level of 0.1 were used to build up univariate and multivariate models. Results: After adjustment for identified prognostic factors, moderately (5.1- 30 ng/mL) and highly (> 30 ng/mL) elevated carcinoembryonic antigen (CEA) serum levels were both predictive for the benefit of perioperative chemotherapy (interaction P = 0.07; hazard ratio [HR] = 0.58 and HR = 0.52 for treatment benefit). For patients with moderately or highly elevated CEA (>5 ng/mL), the 3-year PFS was 35% with perioperative chemotherapy compared to 20% with surgery alone. Performance status (PS) 0 and BMI lower than 30 were also predictive for the benefit of perioperative chemotherapy (interaction P = 0.04 and P = 0.02). However, the number of patients with PS1 and BMI 30 or higher were limited. The benefit of perioperative therapy was not influenced by the number of metastatic lesions (1 vs 2-4, interaction HR = 0.98). Conclusions: Perioperative FOLFOX seems to benefit in particular patients with resectable liver metastases from CRC when CEA is elevated and when PS is unaffected, regardless of the number of metastatic lesions.
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A08 01  1  ENG  @1 Predictive Factors for the Benefit of Perioperative FOLFOX for Resectable Liver Metastasis in Colorectal Cancer Patients (EORTC Intergroup Trial 40983)
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A11 03  1    @1 GRUENBERGER (Thomas)
A11 04  1    @1 GLIMELIUS (Bengt)
A11 05  1    @1 POSTON (Graeme J.)
A11 06  1    @1 SCHLAG (Peter M.)
A11 07  1    @1 ROUGIER (Philippe)
A11 08  1    @1 BECHSTEIN (Wolf O.)
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A11 10  1    @1 WALPOLE (Euan T.)
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A11 12  1    @1 JAECK (Daniel)
A11 13  1    @1 MIRZA (Darius)
A11 14  1    @1 PARKS (Rowan W.)
A11 15  1    @1 COLLETTE (Laurence)
A11 16  1    @1 VAN CUTSEM (Eric)
A11 17  1    @1 SCHEITHAUER (Werner)
A11 18  1    @1 LUTZ (Manfred P.)
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C01 01    ENG  @0 Objective: In EORTC study 40983, perioperative FOLFOX increased progression-free survival (PFS) compared with surgery alone for patients with initially 1 to 4 resectable liver metastases from colorectal cancer (CRC). We conducted an exploratory retrospective analysis to identify baseline factors possibly predictive for a benefit of perioperative FOLFOX on PFS. Methods: The analysis was based on 237 events from 342 eligible patients. Cox proportional hazards regression models with a significance level of 0.1 were used to build up univariate and multivariate models. Results: After adjustment for identified prognostic factors, moderately (5.1- 30 ng/mL) and highly (> 30 ng/mL) elevated carcinoembryonic antigen (CEA) serum levels were both predictive for the benefit of perioperative chemotherapy (interaction P = 0.07; hazard ratio [HR] = 0.58 and HR = 0.52 for treatment benefit). For patients with moderately or highly elevated CEA (>5 ng/mL), the 3-year PFS was 35% with perioperative chemotherapy compared to 20% with surgery alone. Performance status (PS) 0 and BMI lower than 30 were also predictive for the benefit of perioperative chemotherapy (interaction P = 0.04 and P = 0.02). However, the number of patients with PS1 and BMI 30 or higher were limited. The benefit of perioperative therapy was not influenced by the number of metastatic lesions (1 vs 2-4, interaction HR = 0.98). Conclusions: Perioperative FOLFOX seems to benefit in particular patients with resectable liver metastases from CRC when CEA is elevated and when PS is unaffected, regardless of the number of metastatic lesions.
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Werner Scheithauer
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</inist:fA14>
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<name sortKey="Poston, Graeme J" sort="Poston, Graeme J" uniqKey="Poston G" first="Graeme J." last="Poston">Graeme J. Poston</name>
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<inist:fA14 i1="11">
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<s1>Hopital Universitaire Hautepierre</s1>
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<s1>University Hospital Birmingham</s1>
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<sZ>16 aut.</sZ>
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<s1>Department of Internal Medicine I & Comprehensive Cancer Center</s1>
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<sZ>17 aut.</sZ>
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<wicri:noCountry>INC</wicri:noCountry>
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<s1>Caritasklinik St Theresa, Medical Department</s1>
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<sZ>18 aut.</sZ>
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<sZ>19 aut.</sZ>
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<title level="j" type="main">Annals of surgery</title>
<title level="j" type="abbreviated">Ann. surg.</title>
<idno type="ISSN">0003-4932</idno>
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<title level="j" type="main">Annals of surgery</title>
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<term>Clinical trial</term>
<term>Colorectal cancer</term>
<term>Efficiency</term>
<term>European Organization for Research and Treatment of Cancer</term>
<term>Human</term>
<term>Liver cancer</term>
<term>Liver metastasis</term>
<term>Medicine</term>
<term>Patient</term>
<term>Perioperative</term>
<term>Predictive factor</term>
<term>Surgery</term>
<term>Treatment</term>
</keywords>
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<term>Cancer du foie</term>
<term>Facteur prédictif</term>
<term>Efficacité</term>
<term>Métastase foie</term>
<term>Périopératoire</term>
<term>Homme</term>
<term>Cancer colorectal</term>
<term>Malade</term>
<term>Essai clinique</term>
<term>Médecine</term>
<term>Chirurgie</term>
<term>Traitement</term>
<term>EORTC</term>
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<div type="abstract" xml:lang="en">Objective: In EORTC study 40983, perioperative FOLFOX increased progression-free survival (PFS) compared with surgery alone for patients with initially 1 to 4 resectable liver metastases from colorectal cancer (CRC). We conducted an exploratory retrospective analysis to identify baseline factors possibly predictive for a benefit of perioperative FOLFOX on PFS. Methods: The analysis was based on 237 events from 342 eligible patients. Cox proportional hazards regression models with a significance level of 0.1 were used to build up univariate and multivariate models. Results: After adjustment for identified prognostic factors, moderately (5.1- 30 ng/mL) and highly (> 30 ng/mL) elevated carcinoembryonic antigen (CEA) serum levels were both predictive for the benefit of perioperative chemotherapy (interaction P = 0.07; hazard ratio [HR] = 0.58 and HR = 0.52 for treatment benefit). For patients with moderately or highly elevated CEA (>5 ng/mL), the 3-year PFS was 35% with perioperative chemotherapy compared to 20% with surgery alone. Performance status (PS) 0 and BMI lower than 30 were also predictive for the benefit of perioperative chemotherapy (interaction P = 0.04 and P = 0.02). However, the number of patients with PS1 and BMI 30 or higher were limited. The benefit of perioperative therapy was not influenced by the number of metastatic lesions (1 vs 2-4, interaction HR = 0.98). Conclusions: Perioperative FOLFOX seems to benefit in particular patients with resectable liver metastases from CRC when CEA is elevated and when PS is unaffected, regardless of the number of metastatic lesions.</div>
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<s1>Predictive Factors for the Benefit of Perioperative FOLFOX for Resectable Liver Metastasis in Colorectal Cancer Patients (EORTC Intergroup Trial 40983)</s1>
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<sZ>4 aut.</sZ>
</fA14>
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<sZ>4 aut.</sZ>
</fA14>
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<s1>University Hospital Aintree</s1>
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<s1>Robert-Roessle-Klinik, Humboldt-Universitat Berlin, Surgery Department</s1>
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<s1>Centre Hospitalier Universitaire Ambroise Pare, Assistance Publique Hôpitaux de Paris, Departments of Surgery and Oncology</s1>
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<sZ>19 aut.</sZ>
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<s1>Klinikum der Johann-Wolfgang-Goethe-Universität, Department of General and Vascular Surgery</s1>
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<sZ>8 aut.</sZ>
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<s1>University Department of Surgery, Southampton General Hospital</s1>
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<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="11">
<s1>Princess Alexandra Hospital-University of Queensland, Woolloongabba, Brisbane</s1>
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<sZ>10 aut.</sZ>
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<fA14 i1="12">
<s1>Bristol Royal Infirmary</s1>
<s2>Bristol</s2>
<s3>GBR</s3>
<sZ>11 aut.</sZ>
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<fA14 i1="13">
<s1>Hopital Universitaire Hautepierre</s1>
<s2>Strasbourg</s2>
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<sZ>12 aut.</sZ>
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<s1>University Hospital Birmingham</s1>
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<s1>The Royal Infirmary of Edinburgh</s1>
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<sZ>14 aut.</sZ>
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<s1>University Hospital Gasthuisberg, Digestive Oncology Unit</s1>
<s2>Leuven</s2>
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<sZ>16 aut.</sZ>
</fA14>
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<s1>Department of Internal Medicine I & Comprehensive Cancer Center</s1>
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<sZ>17 aut.</sZ>
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<s1>Caritasklinik St Theresa, Medical Department</s1>
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<s3>DEU</s3>
<sZ>18 aut.</sZ>
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<fA17 i1="01" i2="1">
<s1>EORTC Gastro-Intestinal Tract Cancer Group, Cancer Research UK (CRUK), Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO)</s1>
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<s0>Objective: In EORTC study 40983, perioperative FOLFOX increased progression-free survival (PFS) compared with surgery alone for patients with initially 1 to 4 resectable liver metastases from colorectal cancer (CRC). We conducted an exploratory retrospective analysis to identify baseline factors possibly predictive for a benefit of perioperative FOLFOX on PFS. Methods: The analysis was based on 237 events from 342 eligible patients. Cox proportional hazards regression models with a significance level of 0.1 were used to build up univariate and multivariate models. Results: After adjustment for identified prognostic factors, moderately (5.1- 30 ng/mL) and highly (> 30 ng/mL) elevated carcinoembryonic antigen (CEA) serum levels were both predictive for the benefit of perioperative chemotherapy (interaction P = 0.07; hazard ratio [HR] = 0.58 and HR = 0.52 for treatment benefit). For patients with moderately or highly elevated CEA (>5 ng/mL), the 3-year PFS was 35% with perioperative chemotherapy compared to 20% with surgery alone. Performance status (PS) 0 and BMI lower than 30 were also predictive for the benefit of perioperative chemotherapy (interaction P = 0.04 and P = 0.02). However, the number of patients with PS1 and BMI 30 or higher were limited. The benefit of perioperative therapy was not influenced by the number of metastatic lesions (1 vs 2-4, interaction HR = 0.98). Conclusions: Perioperative FOLFOX seems to benefit in particular patients with resectable liver metastases from CRC when CEA is elevated and when PS is unaffected, regardless of the number of metastatic lesions.</s0>
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</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Metástasis hígado</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Périopératoire</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Perioperative</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Perioperatorio</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Homme</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Human</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Cancer colorectal</s0>
<s2>NM</s2>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Colorectal cancer</s0>
<s2>NM</s2>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Cancer de colon y recto</s0>
<s2>NM</s2>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Malade</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Patient</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Enfermo</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Ensayo clínico</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Médecine</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Medicine</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Medicina</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Chirurgie</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Surgery</s0>
<s5>12</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Cirugía</s0>
<s5>12</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>25</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>25</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>EORTC</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>European Organization for Research and Treatment of Cancer</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Pathologie de l'appareil digestif</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Digestive diseases</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Aparato digestivo patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Pathologie du foie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Hepatic disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Hígado patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Pathologie du côlon</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Colonic disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Colón patología</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Pathologie de l'intestin</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Intestinal disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Intestino patología</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Pathologie du rectum</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Rectal disease</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Recto patología</s0>
<s5>42</s5>
</fC07>
<fN21>
<s1>156</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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