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Originally published as JCO Early Release 10.1200/JCO.2004.09.046 on December 9 2003

Journal of Clinical Oncology, Vol 22, No 1 (January 1), 2004: pp. 23-30
© 2004 American Society of Clinical Oncology.
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A Randomized Controlled Trial of Fluorouracil Plus Leucovorin, Irinotecan, and Oxaliplatin Combinations in Patients With Previously Untreated Metastatic Colorectal Cancer

Richard M. Goldberg, Daniel J. Sargent, Roscoe F. Morton, Charles S. Fuchs, Ramesh K. Ramanathan, Stephen K. Williamson, Brian P. Findlay, Henry C. Pitot, Steven R. Alberts

From the North Central Cancer Treatment Group, Divisions of Hematology/Oncology and Medical Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC; North Central Cancer Treatment Group, Division of Biostatistics, Mayo Clinic, Rochester, MN; North Central Cancer Treatment Group, Iowa Oncology Research Association Community Clinical Oncology Program, Des Moines, IA; Cancer and Acute Leukemia Group B, Department of Oncology, Dana-Farber Cancer Institute, Boston, MA; Eastern Cooperative Oncology Group, Division of Medical Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Southwestern Oncology Group, Division of Hematology and Oncology, University of Kansas Medical Center, Kansas City, KS; National Cancer Institute of Canada, St Catharines, Ontario, Canada.

Address reprint requests to Richard M. Goldberg, MD, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, CB#7305, 3009 Old Clinic Building, Chapel Hill, NC 27599-7305; e-mail: goldberg{at}med.unc.edu

PURPOSE: Three agents with differing mechanisms of action are available for treatment of advanced colorectal cancer: fluorouracil, irinotecan, and oxaliplatin. In this study, we compared the activity and toxicity of three different two-drug combinations in patients with metastatic colorectal cancer who had not been treated previously for advanced disease.

PATIENTS AND METHODS: Patients were concurrently randomly assigned to receive irinotecan and bolus fluorouracil plus leucovorin (IFL, control combination), oxaliplatin and infused fluorouracil plus leucovorin (FOLFOX), or irinotecan and oxaliplatin (IROX). The primary end point was time to progression, with secondary end points of response rate, survival time, and toxicity.

RESULTS: A total of 795 patients were randomly assigned between May 1999 and April 2001. A median time to progression of 8.7 months, response rate of 45%, and median survival time of 19.5 months were observed for FOLFOX. These results were significantly superior to those observed for IFL for all end points (6.9 months, 31%, and 15.0 months, respectively) or for IROX (6.5 months, 35%, and 17.4 months, respectively) for time to progression and response. The FOLFOX regimen had significantly lower rates of severe nausea, vomiting, diarrhea, febrile neutropenia, and dehydration. Sensory neuropathy and neutropenia were more common with the regimens containing oxaliplatin.

CONCLUSION: The FOLFOX regimen of oxaliplatin and infused fluorouracil plus leucovorin was active and comparatively safe. It should be considered as a standard therapy for patients with advanced colorectal cancer.

Supported by National Institutes of Health grants CA25224, CA32102, CA38926, CA21115, and CA77202, Pharmacia Corp, and Sanofi-Synthelabo. Pharmacia and Sanofi-Synthelabo provided irinotecan and oxaliplatin, respectively, for this study, and both approved the study protocol.

Presented in part at the 2001 (May 12-15, 2001, San Francisco, CA), 2002 (May 18-21, 2002, Orlando, FL), and 2003 (May 31-June 3, 2003, Chicago, IL) Annual Meetings of the American Society of Clinical Oncology.

Nothing in this article implies endorsement of the products of Pharmacia (Pfizer) Corp or Sanofi-Synthelabo.

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


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Safety and Efficacy of Oxaliplatin and Fluoropyrimidine Regimens With or Without Bevacizumab As First-Line Treatment of Metastatic Colorectal Cancer: Results of the TREE Study
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Individual Fluorouracil Dose Adjustment Based on Pharmacokinetic Follow-Up Compared With Conventional Dosage: Results of a Multicenter Randomized Trial of Patients With Metastatic Colorectal Cancer
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Administration of Cetuximab Every 2 Weeks in the Treatment of Metastatic Colorectal Cancer: An Effective, More Convenient Alternative to Weekly Administration?
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