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Annals of Oncology Advance Access originally published online on May 22, 2009
Annals of Oncology 2009 20(8):1383-1386; doi:10.1093/annonc/mdp012
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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

FOLFOX in patients with metastatic colorectal cancer and high alkaline phosphatase level: an exploratory cohort of the GERCOR OPTIMOX1 study

B. Chibaudel1, C. Tournigand1, P. Artru2, T. André3, A. Cervantes4, A. Figer5, G. Lledo2, M. Flesch6, M. Buyse7, L. Mineur8, E. Carola9, F. Rivera10, N. Perez-Staub1, C. Louvet11 and A. de Gramont11,*

1 Department of Medical Oncology, Saint Antoine Hospital, Assistance Publique Hôpitaux de Paris, Paris
2 Department of Medical Oncology and Gastroenterology, Jean Mermoz Hospital, Lyon
3 Department of Gastroenterology, La Pitié-Salpétrière Hospital, Assistance Publique Hôpitaux de Paris, Pierre et Marie Curie University, INSERM U893, Paris, France
4 Department of Medical Oncology, Hospital Clinic University, Valencia, Spain
5 Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
6 Department of Medical Oncology, Devron Hospital, Dijon, France
7 International Drug Development Institute, Brussels, Belgium
8 Department of Medical Oncology and Radiotherapy, Institut Sainte Catherine, Avignon
9 Department of Medical Oncology, Senlis Hospital, Senlis, France
10 Department of Medical Oncology, Hospital University Marques de Valdecilla, Santander, Spain
11 Department of Medical Oncology, Saint Antoine Hospital, Assistance Publique Hôpitaux de Paris, Pierre et Marie Curie University, INSERM U893, Paris, France

* Correspondence to: Prof. A. de Gramont, Hôpital Saint-Antoine, 184, rue du Faubourg Saint-Antoine, 75571 Paris Cedex 12, 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: Alkaline phosphatase (ALP) is a strong prognostic factor in patients with metastatic colorectal cancer (MCRC). Patients with ALP more than three times the upper limit of normal (ULN) were excluded from our previous studies evaluating chemotherapy. An exploratory cohort of patients with ALP >3 ULN was included in the OPTIMOX1 study.

Patients and methods: Previously untreated patients with MCRC were randomized to FOLFOX4 until progression (arm A) or FOLFOX7 for six cycles, maintenance without oxaliplatin for 12 cycles and reintroduction of FOLFOX7 (arm B). Patients were stratified according to ALP level ≤3 ULN versus 3–5 ULN.

Results: Among the 620 patients in OPTIMOX1 study, 63 had ALP 3–5 ULN; 33 in arm A and 30 in arm B. The response rate in these patients was 56% versus 59% in patients with ALP ≤3 ULN. Median progression-free survival and overall survival were, respectively, 6.4 and 11.5 months in patients with ALP 3–5 ULN and 9.0 and 21.1 months in patients with ALP ≤3 ULN. Thirty-three percent of the patients in the cohort experienced grade 3/4 toxicity.

Conclusion: Both FOLFOX regimens achieved high tumor response rates and offer good palliation in MCRC patients with a poor prognosis.

Key words: 5-fluorouracil, FOLFOX, leucovorin, metastatic colorectal cancer, oxaliplatin, poor prognosis patients

Received for publication November 17, 2008. Revision received December 29, 2008. Accepted for publication January 8, 2009.


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