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Annals of Oncology Advance Access originally published online on January 19, 2009
Annals of Oncology 2009 20(6):1042-1047; doi:10.1093/annonc/mdn730
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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

Efficacy of FOLFIRI-3 (irinotecan D1,D3 combined with LV5-FU) or other irinotecan-based regimens in oxaliplatin-pretreated metastatic colorectal cancer in the GERCOR OPTIMOX1 study

F.-C. Bidard1, C. Tournigand1, T. André2, M. Mabro3, A. Figer4, A. Cervantes5, G. Lledo6, L. Bengrine-Lefevre1, F. Maindrault-Goebel1, C. Louvet1 and A. de Gramont1,*

1 Department of Medical Oncology, Hospital Saint Antoine, Paris
2 Department of Gastro-Enterology, Hospital Pitié-Salpêtrière, Paris
3 Department of Medical Oncology, Hospital Foch, Suresnes, France
4 Department of Medical Oncology, Sourasky Medical Center, Tel Aviv, Israël
5 Department of Medical Oncology, Hospital Clinic, University of Valencia, Valencia, Spain
6 Department of Medical Oncology, Clinic Saint Jean, Lyon, France

* Correspondence to: Prof. A. de Gramont, Department of Medical Oncology, Hôpital Saint Antoine, Paris, France. Tel: +33-1-49-28-23-36; Fax: +33-1-49-28-23-44; E-mail: aimery.de-gramont{at}sat.aphp.fr

Background: Second-line irinotecan-based chemotherapy is commonly used in metastatic colorectal cancers after first-line oxaliplatin-based chemotherapy. No standard schedule of irinotecan has been established in this situation.

Patients and methods: Metastatic colorectal cancer patients included in the OPTIMOX1 phase III study received first-line oxaliplatin-based chemotherapy (FOLFOX). No second line was defined in the protocol, but data concerning second line were prospectively registered. Inclusion criterion was patients receiving an irinotecan-based second-line chemotherapy. Second-line progression-free survival (PFS) and tumor response were evaluated according to type of irinotecan-based regimen administered.

Results: A total of 342 patients received irinotecan-based chemotherapy as second-line chemotherapy: FOLFIRI-3 [n = 109, irinotecan 100 mg/m2 days 1 and 3 combined with leucovorin (LV) 400 mg/m2 day 1 and 46-h continuous 5-fluorouracil (5-FU) 2000 mg/m2], FOLFIRI-1 (n = 112, irinotecan 180 mg/m2 day 1 combined with LV 400 mg/m2 day 1, 5-FU bolus 400 mg/m2 and 46-h continuous 5-FU 2400 mg/m2) and other various irinotecan-based regimens (n = 121). Median second-line PFS was 3.0 months (FOLFIRI-3: 3.7 months; FOLFIRI-1: 3.0 months; other regimens: 2.3 months). In multivariate analysis, FOLFIRI-3 regimen (relative risk 0.43, 95% confidence interval 0.28–0.68, P = 0.0003) and lactate deshydrogenase level at inclusion (P = 0.0006) in OPTIMOX1 were associated with a longer second-line PFS.

Conclusion: In unselected patients pretreated with oxaliplatin, PFS in second line appeared to be improved by FOLFIRI-3 regimen.

Key words: FOLFIRI-3, FOLFIRI-1, irinotecan, metastatic colorectal cancer, second-line chemotherapy

Received for publication August 2, 2008. Revision received November 1, 2008. Accepted for publication November 3, 2008.


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