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Medline ® Abstract for Reference 97

of 'Adjuvant therapy for resected stage III (node-positive) colon cancer'

97
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A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802).
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Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, BouchéO, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A
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Ann Oncol. 2009;20(4):674. Epub 2009 Jan 29.
 
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/m(2), 2-h infusion, 5-fluorouracil (5-FU) 400 mg/m(2) bolus, 600 mg/m(2) 22-h continuous infusion, days 1 and 2]or B-LV5FU2 + IRI (irinotecan 180 mg/m(2) 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.
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Centre de Recherche et de Lutte contre le Cancer Val d'Aurelle, Montpellier, France. marc.ychou@valdorel.fnclcc.fr
PMID