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Annals of Oncology Advance Access originally published online on January 29, 2009
Annals of Oncology 2009 20(4):674-680; doi:10.1093/annonc/mdn680
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802)

M. Ychou1,*, J.-L. Raoul2, J.-Y. Douillard3, S. Gourgou-Bourgade1, R. Bugat4, L. Mineur5, F. Viret6, Y. Becouarn7, O. Bouché8, E. Gamelin9, M. Ducreux10, T. Conroy11, J.-F. Seitz12, L. Bedenne13 and A. Kramar1

1 CRLC Val d'Aurelle, Montpellier
2 CRLC Eugène Marquis, Rennes, France and European University in Brittany
3 CRLC René Gauducheau, St Herblain
4 CRLC Claudius Régaud, Toulouse
5 Clinique Sainte Catherine, Avignon
6 CRLC Antoine Lacassagne, Nice
7 Institut Bergonié, Bordeaux
8 CH R. Debré, Reims
9 CRLC Paul Papin, Angers
10 Institut Gustave Roussy, Villejuif
11 CRLC Alexis Vautrin, Vandoeuvre-les-Nancy
12 CH La Timone, Marseille
13 CHU du Bocage, Dijon, France

* Correspondence to: Prof. M. Ychou, Centre de Recherche et de Lutte contre le Cancer Val d'Aurelle, 208 rue des apothicaires, 34298 Montpellier Cedex 05, France. Tel: +33-4-67-61-30-66; Fax: +33-4-67-61-30-22; E-mail: marc.ychou{at}valdorel.fnclcc.fr

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: A—LV5FU2 [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 B—LV5FU2 + 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 0.85–1.47, P = 0.42] even when adjusted for prognostic factors (adjusted HR = 0.98, 95% CI 0.74–1.31, 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.

Key words: adjuvant chemotherapy, colon cancer, irinotecan

Received for publication April 14, 2008. Revision received September 22, 2008. Accepted for publication September 23, 2008.


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