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Originally published as JCO Early Release 10.1200/JCO.2004.05.113 on December 2 2003

Journal of Clinical Oncology, Vol 22, No 2 (January 15), 2004: pp. 229-237
© 2004 American Society of Clinical Oncology.
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FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study

Christophe Tournigand, Thierry André, Emmanuel Achille, Gérard Lledo, Michel Flesh, Dominique Mery-Mignard, Emmanuel Quinaux, Corinne Couteau, Marc Buyse, Gérard Ganem, Bruno Landi, Philippe Colin, Christophe Louvet, Aimery de Gramont

From the GERCOR; Hôpital Saint-Antoine; Hôpital Tenon; Hôpital Georges Pompidou; Aventis; International Drug Development Institute, Paris; Clinique de l'Orangerie, Strasbourg; Clinique Saint-Jean, Lyon; Clinique Drevon, Dijon; Centre Jean Bernard, Le Mans; Clinique Courlancy, Reims, France; International Drug Development Institute, Brussels, Belgium

Address reprint requests to A. de Gramont, MD, Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75571 Paris, Cedex 12, France; e-mail: aimery.de-gramont{at}sat.ap-hop-paris.fr.

PURPOSE: In metastatic colorectal cancer, phase III studies have demonstrated the superiority of fluorouracil (FU) with leucovorin (LV) in combination with irinotecan or oxaliplatin over FU + LV alone. This phase III study investigated two sequences: folinic acid, FU, and irinotecan (FOLFIRI) followed by folinic acid, FU, and oxaliplatin (FOLFOX6; arm A), and FOLFOX6 followed by FOLFIRI (arm B).

PATIENTS AND METHODS: Previously untreated patients with assessable disease were randomly assigned to receive a 2-hour infusion of l-LV 200 mg/m2 or dl-LV 400 mg/m2 followed by a FU bolus 400 mg/m2 and 46-hour infusion 2,400 to 3,000 mg/m2 every 46 hours every 2 weeks, either with irinotecan 180 mg/m2 or with oxaliplatin 100 mg/m2 as a 2-hour infusion on day 1. At progression, irinotecan was replaced by oxaliplatin (arm A), or oxaliplatin by irinotecan (arm B).

RESULTS: Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI (P = .99). Median second progression-free survival (PFS) was 14.2 months in arm A versus 10.9 in arm B (P = .64). In first-line therapy, FOLFIRI achieved 56% response rate (RR) and 8.5 months median PFS, versus FOLFOX6 which achieved 54% RR and 8.0 months median PFS (P = .26). Second-line FOLFIRI achieved 4% RR and 2.5 months median PFS, versus FOLFOX6 which achieved 15% RR and 4.2 months PFS. In first-line therapy, National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis, nausea/vomiting, and grade 2 alopecia were more frequent with FOLFIRI, and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6.

CONCLUSION: Both sequences achieved a prolonged survival and similar efficacy. The toxicity profiles were different.

Sponsored by Aventis, Paris, France.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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M. L. Rothenberg, J. V. Cox, C. Butts, M. Navarro, Y.-J. Bang, R. Goel, S. Gollins, L. L. Siu, S. Laguerre, and D. Cunningham
Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: a randomized phase III noninferiority study
Ann. Onc., October 1, 2008; 19(10): 1720 - 1726.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
S. R. Alberts and L. D. Wagman
Chemotherapy for Colorectal Cancer Liver Metastases
Oncologist, October 1, 2008; 13(10): 1063 - 1073.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
B. H. O'Neil and R. M. Goldberg
Innovations in Chemotherapy for Metastatic Colorectal Cancer: An Update of Recent Clinical Trials
Oncologist, October 1, 2008; 13(10): 1074 - 1083.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Ward, J. A. Guthrie, M. B. Sheridan, S. Boyes, J. T. Smith, D. Wilson, J. I. Wyatt, D. Treanor, and P. J. Robinson
Sinusoidal Obstructive Syndrome Diagnosed With Superparamagnetic Iron Oxide-Enhanced Magnetic Resonance Imaging in Patients With Chemotherapy-Treated Colorectal Liver Metastases
J. Clin. Oncol., September 10, 2008; 26(26): 4304 - 4310.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
P. M. Wilson, W. Fazzone, M. J. LaBonte, J. Deng, N. Neamati, and R. D. Ladner
Novel opportunities for thymidylate metabolism as a therapeutic target
Mol. Cancer Ther., September 1, 2008; 7(9): 3029 - 3037.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
W. Cacheux, T. Boisserie, L. Staudacher, O. Vignaux, B. Dousset, O. Soubrane, B. Terris, C. Mateus, S. Chaussade, and F. Goldwasser
Reversible tumor growth acceleration following bevacizumab interruption in metastatic colorectal cancer patients scheduled for surgery
Ann. Onc., September 1, 2008; 19(9): 1659 - 1661.
[Full Text] [PDF]

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 JCOHome page
R. Adam, R. J. de Haas, D. A. Wicherts, T. A. Aloia, V. Delvart, D. Azoulay, H. Bismuth, and D. Castaing
Is Hepatic Resection Justified After Chemotherapy in Patients With Colorectal Liver Metastases and Lymph Node Involvement?
J. Clin. Oncol., August 1, 2008; 26(22): 3672 - 3680.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
D. Arnold, T. Hohler, C. Dittrich, F. Lordick, T. Seufferlein, J. Riemann, E. Woll, T. Herrmann, A. Zubel, and H.-J. Schmoll
Cetuximab in combination with weekly 5-fluorouracil/folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: a phase Ib/II study of the AIO GI Group
Ann. Onc., August 1, 2008; 19(8): 1442 - 1449.
[Abstract] [Full Text] [PDF]

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 JNMHome page
R. I. Sharma and T. A.D. Smith
Colorectal Tumor Cells Treated with 5-FU, Oxaliplatin, Irinotecan, and Cetuximab Exhibit Changes in 18F-FDG Incorporation Corresponding to Hexokinase Activity and Glucose Transport
J. Nucl. Med., August 1, 2008; 49(8): 1386 - 1394.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. McKibbin, C. R. Frei, R. E. Greene, P. Kwan, J. Simon, and J. M. Koeller
Disparities in the Use of Chemotherapy and Monoclonal Antibody Therapy for Elderly Advanced Colorectal Cancer Patients in the Community Oncology Setting
Oncologist, August 1, 2008; 13(8): 876 - 885.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
K. Shitara, M. Munakata, O. Muto, and Y. Sakata
Metastatic Rectal Cancer Responding to Third-line Therapy Employing Bevacizumab After Failure of Oxaliplatin and Irinotecan: Case Report
Jpn. J. Clin. Oncol., July 1, 2008; 38(7): 493 - 496.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
P. Pfeiffer, D. Nielsen, J. Bjerregaard, C. Qvortrup, M. Yilmaz, and B. Jensen
Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil
Ann. Onc., June 1, 2008; 19(6): 1141 - 1145.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
L. B. J. van Iersel, H. Gelderblom, A. L. Vahrmeijer, E. L. van Persijn van Meerten, F. G. J. Tijl, H. Putter, H. H. Hartgrink, P. J. K. Kuppen, J. W. R. Nortier, R. A. E. M. Tollenaar, et al.
Isolated hepatic melphalan perfusion of colorectal liver metastases: outcome and prognostic factors in 154 patients
Ann. Onc., June 1, 2008; 19(6): 1127 - 1134.
[Abstract] [Full Text] [PDF]

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 Am J Health Syst PharmHome page
R. N. Schwartz
Management of early and advanced colorectal cancer: Therapeutic issues
Am. J. Health Syst. Pharm., June 1, 2008; 65(11_Supplement_4): S8 - S14.
[Abstract] [Full Text] [PDF]

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 Am J Health Syst PharmHome page
J. R. Hecht
Current and emerging therapies for metastatic colorectal cancer: Applying research findings to clinical practice
Am. J. Health Syst. Pharm., June 1, 2008; 65(11_Supplement_4): S15 - S21.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. F. Sobrero, J. Maurel, L. Fehrenbacher, W. Scheithauer, Y. A. Abubakr, M. P. Lutz, M. E. Vega-Villegas, C. Eng, E. U. Steinhauer, J. Prausova, et al.
EPIC: Phase III Trial of Cetuximab Plus Irinotecan After Fluoropyrimidine and Oxaliplatin Failure in Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., May 10, 2008; 26(14): 2311 - 2319.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
C.-H. Kohne, J. De Greve, J. T. Hartmann, I. Lang, P. Vergauwe, K. Becker, D. Braumann, E. Joosens, L. Muller, J. Janssens, et al.
Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015
Ann. Onc., May 1, 2008; 19(5): 920 - 926.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
B. Glimelius, H. Sorbye, L. Balteskard, P. Bystrom, P. Pfeiffer, K. Tveit, R. Heikkila, N. Keldsen, M. Albertsson, H. Starkhammar, et al.
A randomized phase III multicenter trial comparing irinotecan in combination with the Nordic bolus 5-FU and folinic acid schedule or the bolus/infused de Gramont schedule (Lv5FU2) in patients with metastatic colorectal cancer
Ann. Onc., May 1, 2008; 19(5): 909 - 914.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. Pessino, S. Artale, S. Sciallero, A. Guglielmi, G. Fornarini, I.C. Andreotti, S. Mammoliti, D. Comandini, F. Caprioni, E. Bennicelli, et al.
First-line single-agent cetuximab in patients with advanced colorectal cancer
Ann. Onc., April 1, 2008; 19(4): 711 - 716.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
C.-H. Kohne, G. Folprecht, R. M. Goldberg, E. Mitry, and P. Rougier
Chemotherapy in Elderly Patients with Colorectal Cancer
Oncologist, April 1, 2008; 13(4): 390 - 402.
[Abstract] [Full Text] [PDF]

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 JCOHome page
G. Folprecht, M. T. Seymour, L. Saltz, J.-Y. Douillard, H. Hecker, R. J. Stephens, T. S. Maughan, E. Van Cutsem, P. Rougier, E. Mitry, et al.
Irinotecan/Fluorouracil Combination in First-Line Therapy of Older and Younger Patients With Metastatic Colorectal Cancer: Combined Analysis of 2,691 Patients in Randomized Controlled Trials
J. Clin. Oncol., March 20, 2008; 26(9): 1443 - 1451.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. Folprecht, J. Tabernero, C.-H. Kohne, C. Zacharchuk, L. Paz-Ares, F. Rojo, S. Quinn, E. Casado, R. Salazar, R. Abbas, et al.
Phase I Pharmacokinetic/Pharmacodynamic Study of EKB-569, an Irreversible Inhibitor of the Epidermal Growth Factor Receptor Tyrosine Kinase, in Combination with Irinotecan, 5-Fluorouracil, and Leucovorin (FOLFIRI) in First-Line Treatment of Patients with Metastatic Colorectal Cancer
Clin. Cancer Res., January 1, 2008; 14(1): 215 - 223.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. M. Pawlik, R. D. Schulick, and M. A. Choti
Expanding Criteria for Resectability of Colorectal Liver Metastases
Oncologist, January 1, 2008; 13(1): 51 - 64.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
Y. Inaba, H. Yamaura, Y. Sato, M. Najima, H. Shimamoto, H. Nishiofuku, T. Ura, and K. Muro
Central Venous Access Port-related Complications in Outpatient Chemotherapy for Colorectal Cancer
Jpn. J. Clin. Oncol., December 4, 2007; (2007) hym118v1.
[Abstract] [Full Text] [PDF]


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