A phase III randomised trial of LV5FU2 irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802)
Identifieur interne : 000B63 ( Main/Exploration ); précédent : 000B62; suivant : 000B64A phase III randomised trial of LV5FU2 irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802)
Auteurs : M. Ychou [France] ; J.-L. Raoul ; J.-Y. Douillard ; S. Gourgou-Bourgade ; R. Bugat [France] ; L. Mineur ; F. Viret ; Y. Becouarn ; O. Bouch ; E. Gamelin ; M. Ducreux ; T. Conroy ; J.-F. Seitz [France] ; L. Bedenne [France] ; A. KramarSource :
- Annals of Oncology [ 0923-7534 ] ; 2009-01-29.
Abstract
Background: This multicenter adjuvant phase III trial evaluated the addition of irinotecan to LV5FU2 in colon cancer patients at high risk of relapse. Patients and methods: A total of 400 patients with histologically proven primary colon cancer with postoperative N1 detected by occlusion/perforation or N2 were randomised to: ALV5FU2 [leucovorin 200 mg/m2, 2-h infusion, 5-fluorouracil (5-FU) 400 mg/m2 bolus, 600 mg/m2 22-h continuous infusion, days 1 and 2] or BLV5FU2 IRI (irinotecan 180 mg/m2 90-min infusion day 1 LV5FU2) fortnightly for 12 cycles. Primary end point was disease-free survival (DFS). Results: Median follow-up was 63 months. Significantly more T4 tumours and 15 or more positive lymph nodes were observed in arm B. 5-FU relative dose intensity (RDI) was >0.80 for 94% and 77% in arms A and B, respectively (P < 0.001). Irinotecan RDI was >0.80 for 70% patients. There were more grades 3 and 4 neutropenia in arm B (4% versus 28%, P < 0.001). The 3-year DFS was 60% [95% confidence interval (CI) 53% to 66%] and 51% (95% CI 44% to 58) in arms A and B, respectively. No difference was observed [hazard ratio (HR) 1.12, 95% CI 0.851.47, P 0.42] even when adjusted for prognostic factors (adjusted HR 0.98, 95% CI 0.741.31, P 0.92). The 5-year overall survival (OS) was 67% (95% CI 59% to 73%) and 61% (95% CI 53% to 67%) in arms A and B, respectively. Conclusion: Adjuvant LV5FU2 IRI compared with LV5FU2 alone in patients at high risk of relapse showed no improvement in DFS and OS.
Url:
DOI: 10.1093/annonc/mdn680
Affiliations:
- France
- Midi-Pyrénées, Occitanie (région administrative), Provence-Alpes-Côte d'Azur
- Dijon, Marseille, Toulouse
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Mineur</name></author><author><name sortKey="Viret, F" sort="Viret, F" uniqKey="Viret F" first="F." last="Viret">F. Viret</name></author><author><name sortKey="Becouarn, Y" sort="Becouarn, Y" uniqKey="Becouarn Y" first="Y." last="Becouarn">Y. Becouarn</name></author><author><name sortKey="Bouch, O" sort="Bouch, O" uniqKey="Bouch O" first="O." last="Bouch">O. Bouch</name></author><author><name sortKey="Gamelin, E" sort="Gamelin, E" uniqKey="Gamelin E" first="E." last="Gamelin">E. Gamelin</name></author><author><name sortKey="Ducreux, M" sort="Ducreux, M" uniqKey="Ducreux M" first="M." last="Ducreux">M. Ducreux</name></author><author><name sortKey="Conroy, T" sort="Conroy, T" uniqKey="Conroy T" first="T." last="Conroy">T. Conroy</name></author><author><name sortKey="Seitz, J F" sort="Seitz, J F" uniqKey="Seitz J" first="J.-F." last="Seitz">J.-F. Seitz</name></author><author><name sortKey="Bedenne, L" sort="Bedenne, L" uniqKey="Bedenne L" first="L." last="Bedenne">L. 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Ychou</name><affiliation></affiliation><affiliation wicri:level="1"><country wicri:rule="url">France</country></affiliation></author><author><name sortKey="Raoul, J L" sort="Raoul, J L" uniqKey="Raoul J" first="J.-L." last="Raoul">J.-L. Raoul</name><affiliation><wicri:noCountry code="subField">Brittany</wicri:noCountry></affiliation></author><author><name sortKey="Douillard, J Y" sort="Douillard, J Y" uniqKey="Douillard J" first="J.-Y." last="Douillard">J.-Y. Douillard</name><affiliation><wicri:noCountry code="subField">Herblain</wicri:noCountry></affiliation></author><author><name sortKey="Gourgou Bourgade, S" sort="Gourgou Bourgade, S" uniqKey="Gourgou Bourgade S" first="S." last="Gourgou-Bourgade">S. Gourgou-Bourgade</name><affiliation><wicri:noCountry code="subField">Montpellier</wicri:noCountry></affiliation></author><author><name sortKey="Bugat, R" sort="Bugat, R" uniqKey="Bugat R" first="R." last="Bugat">R. Bugat</name><affiliation wicri:level="3"><country>France</country><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Midi-Pyrénées</region></placeName><wicri:orgArea>CRLC Claudius Rgaud</wicri:orgArea></affiliation></author><author><name sortKey="Mineur, L" sort="Mineur, L" uniqKey="Mineur L" first="L." last="Mineur">L. Mineur</name><affiliation><wicri:noCountry code="subField">Avignon</wicri:noCountry></affiliation></author><author><name sortKey="Viret, F" sort="Viret, F" uniqKey="Viret F" first="F." last="Viret">F. Viret</name><affiliation><wicri:noCountry code="subField">Nice</wicri:noCountry></affiliation></author><author><name sortKey="Becouarn, Y" sort="Becouarn, Y" uniqKey="Becouarn Y" first="Y." last="Becouarn">Y. Becouarn</name><affiliation><wicri:noCountry code="subField">Bordeaux</wicri:noCountry></affiliation></author><author><name sortKey="Bouch, O" sort="Bouch, O" uniqKey="Bouch O" first="O." last="Bouch">O. Bouch</name><affiliation><wicri:noCountry code="subField">Reims</wicri:noCountry></affiliation></author><author><name sortKey="Gamelin, E" sort="Gamelin, E" uniqKey="Gamelin E" first="E." last="Gamelin">E. Gamelin</name><affiliation><wicri:noCountry code="subField">Angers</wicri:noCountry></affiliation></author><author><name sortKey="Ducreux, M" sort="Ducreux, M" uniqKey="Ducreux M" first="M." last="Ducreux">M. Ducreux</name><affiliation><wicri:noCountry code="subField">Villejuif</wicri:noCountry></affiliation></author><author><name sortKey="Conroy, T" sort="Conroy, T" uniqKey="Conroy T" first="T." last="Conroy">T. Conroy</name><affiliation><wicri:noCountry code="subField">Vandoeuvre-les-Nancy</wicri:noCountry></affiliation></author><author><name sortKey="Seitz, J F" sort="Seitz, J F" uniqKey="Seitz J" first="J.-F." last="Seitz">J.-F. Seitz</name><affiliation wicri:level="3"><country>France</country><placeName><settlement type="city">Marseille</settlement><region type="région" nuts="2">Provence-Alpes-Côte d'Azur</region></placeName><wicri:orgArea>CH La Timone</wicri:orgArea></affiliation></author><author><name sortKey="Bedenne, L" sort="Bedenne, L" uniqKey="Bedenne L" first="L." last="Bedenne">L. Bedenne</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>CHU du Bocage, Dijon</wicri:regionArea><placeName><settlement type="city">Dijon</settlement></placeName></affiliation></author><author><name sortKey="Kramar, A" sort="Kramar, A" uniqKey="Kramar A" first="A." last="Kramar">A. Kramar</name><affiliation><wicri:noCountry code="subField">Montpellier</wicri:noCountry></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2009-01-29">2009-01-29</date><biblScope unit="volume">20</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="674">674</biblScope><biblScope unit="page" to="680">680</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">2CD7BD4F8368FE55C1F451AF43E8117EAFC0A73F</idno><idno type="DOI">10.1093/annonc/mdn680</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background: This multicenter adjuvant phase III trial evaluated the addition of irinotecan to LV5FU2 in colon cancer patients at high risk of relapse. Patients and methods: A total of 400 patients with histologically proven primary colon cancer with postoperative N1 detected by occlusion/perforation or N2 were randomised to: ALV5FU2 [leucovorin 200 mg/m2, 2-h infusion, 5-fluorouracil (5-FU) 400 mg/m2 bolus, 600 mg/m2 22-h continuous infusion, days 1 and 2] or BLV5FU2 IRI (irinotecan 180 mg/m2 90-min infusion day 1 LV5FU2) fortnightly for 12 cycles. Primary end point was disease-free survival (DFS). Results: Median follow-up was 63 months. Significantly more T4 tumours and 15 or more positive lymph nodes were observed in arm B. 5-FU relative dose intensity (RDI) was >0.80 for 94% and 77% in arms A and B, respectively (P < 0.001). Irinotecan RDI was >0.80 for 70% patients. There were more grades 3 and 4 neutropenia in arm B (4% versus 28%, P < 0.001). The 3-year DFS was 60% [95% confidence interval (CI) 53% to 66%] and 51% (95% CI 44% to 58) in arms A and B, respectively. No difference was observed [hazard ratio (HR) 1.12, 95% CI 0.851.47, P 0.42] even when adjusted for prognostic factors (adjusted HR 0.98, 95% CI 0.741.31, P 0.92). The 5-year overall survival (OS) was 67% (95% CI 59% to 73%) and 61% (95% CI 53% to 67%) in arms A and B, respectively. Conclusion: Adjuvant LV5FU2 IRI compared with LV5FU2 alone in patients at high risk of relapse showed no improvement in DFS and OS.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Provence-Alpes-Côte d'Azur</li></region><settlement><li>Dijon</li><li>Marseille</li><li>Toulouse</li></settlement></list><tree><noCountry><name sortKey="Becouarn, Y" sort="Becouarn, Y" uniqKey="Becouarn Y" first="Y." last="Becouarn">Y. Becouarn</name><name sortKey="Bouch, O" sort="Bouch, O" uniqKey="Bouch O" first="O." last="Bouch">O. Bouch</name><name sortKey="Conroy, T" sort="Conroy, T" uniqKey="Conroy T" first="T." last="Conroy">T. Conroy</name><name sortKey="Douillard, J Y" sort="Douillard, J Y" uniqKey="Douillard J" first="J.-Y." last="Douillard">J.-Y. Douillard</name><name sortKey="Ducreux, M" sort="Ducreux, M" uniqKey="Ducreux M" first="M." last="Ducreux">M. Ducreux</name><name sortKey="Gamelin, E" sort="Gamelin, E" uniqKey="Gamelin E" first="E." last="Gamelin">E. Gamelin</name><name sortKey="Gourgou Bourgade, S" sort="Gourgou Bourgade, S" uniqKey="Gourgou Bourgade S" first="S." last="Gourgou-Bourgade">S. Gourgou-Bourgade</name><name sortKey="Kramar, A" sort="Kramar, A" uniqKey="Kramar A" first="A." last="Kramar">A. Kramar</name><name sortKey="Mineur, L" sort="Mineur, L" uniqKey="Mineur L" first="L." last="Mineur">L. Mineur</name><name sortKey="Raoul, J L" sort="Raoul, J L" uniqKey="Raoul J" first="J.-L." last="Raoul">J.-L. Raoul</name><name sortKey="Viret, F" sort="Viret, F" uniqKey="Viret F" first="F." last="Viret">F. Viret</name></noCountry><country name="France"><noRegion><name sortKey="Ychou, M" sort="Ychou, M" uniqKey="Ychou M" first="M." last="Ychou">M. Ychou</name></noRegion><name sortKey="Bedenne, L" sort="Bedenne, L" uniqKey="Bedenne L" first="L." last="Bedenne">L. Bedenne</name><name sortKey="Bugat, R" sort="Bugat, R" uniqKey="Bugat R" first="R." last="Bugat">R. Bugat</name><name sortKey="Seitz, J F" sort="Seitz, J F" uniqKey="Seitz J" first="J.-F." last="Seitz">J.-F. Seitz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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