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Journal of Clinical Oncology, Vol 25, No 30 (October 20), 2007: pp. 4779-4786 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.11.3357 Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study
From the Dana-Farber Cancer Institute, Boston, MA; Georgetown University Lombardi Cancer Center, Washington, DC; Jefferson Medical College, Philadelphia, PA; US Oncology Network, Virginia Oncology Associates, Newport News, VA; US Oncology Network, Tyler Cancer Center, Tyler, TX; Pfizer Global Pharmaceuticals, New York, NY; Lakeridge Health Oshawa, Oshawa, Ontario, Canada; Frankston Hospital, Frankston, Australia; and Christchurch Hospital, Christchurch, New Zealand Address reprint requests to Charles S. Fuchs, MD, Dana-Farber Cancer Institute, 44 Binney St, Office Dana 1232, Boston, MA 02115; e-mail: charles_fuchs{at}dfci.harvard.edu Purpose: This phase III study compared the safety and efficacy of the following three different irinotecan-containing regimens in the first-line treatment of metastatic colorectal cancer: irinotecan plus infusional fluorouracil (FU)/leucovorin (LV) (FOLFIRI), irinotecan plus bolus FU/LV (mIFL), and irinotecan plus oral capecitabine (CapeIRI). Patients and Methods: A total of 430 previously untreated metastatic colorectal cancer patients were randomly assigned to receive FOLFIRI (n = 144), mIFL (n = 141), or CapeIRI (n = 145). Patients were concurrently randomly assigned to a double-blind treatment with celecoxib or placebo. After a protocol amendment, an additional 117 patients were randomly assigned to either FOLFIRI plus bevacizumab (FOLFIRI+Bev; n = 57) or mILF plus bevacizumab (mIFL+Bev; n = 60), whereas the CapeIRI arm was discontinued. The primary study end point was progression-free survival (PFS), with secondary end points of overall survival (OS), response rate, and toxicity.
Results: Median PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (P = .004 for the comparison with FOLFIRI), and 5.8 months for CapeIRI (P = .015). Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (P = .09), and 18.9 months for CapeIRI (P = .27). CapeIRI was associated with higher rates of severe vomiting, diarrhea, and dehydration. After the amendment to add bevacizumab, the median survival time has not yet been reached for FOLFIRI+Bev and was 19.2 months for mIFL+Bev (P = .007). FOLFIRI+Bev was associated with a higher rate of Conclusion: FOLFIRI and FOLFIRI+Bev offered superior activity to their comparators and were comparably safe. An infusional schedule of FU should be the preferred irinotecan-based regimen in first-line metastatic colorectal cancer. Supported by Pfizer Inc, New York, NY. Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006 Atlanta, GA. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. Related Correspondence
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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