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Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Updated Results From the BICC-C Study

Dana-Farber Cancer Institute, Boston, MA

John Marshall

Georgetown University Lombardi Cancer Center, Washington, DC

José Barrueco

Pfizer Global Pharmaceuticals, New York, NY

To the Editor:

We recently published in the October 20, 2007, issue of the Journal of Clinical Oncology, results from a phase III study that compared the safety and efficacy of three different irinotecan-containing regimens in the first-line treatment of metastatic colorectal cancer (mCRC): irinotecan plus infusional florouracil and leucovorin (FU/LV; FOLFIRI), irinotecan plus bolus FU/LV (mIFL), and irinotecan plus oral capecitabine (CapeIRI).¹ The study therefore initially randomly assigned patients to one of three open-label chemotherapy arms (designated as period 1). In April 2004, following US Food and Drug Administration approval of bevacizumab (Bev), the trial was amended to compare FOLFIRI with bevacizumab (FOLFIRI+Bev) with mIFL with bevacizumab (mIFL+Bev), whereas, due to toxicity concerns, further enrollment to CapeIRI was discontinued (designated as period 2). The results for both periods 1 and 2 demonstrated that FOLFIRI and FOLFIRI+Bev offered superior activity to their comparators and were comparably safe.¹ However, at that time, median survival had not yet been reached for FOLFIRI+Bev. Herein, we report updated overall survival data for all patients enrolled in period 2 of this trial.

In period 2, 117 patients were randomly assigned to either FOLFIRI+bevacizumab (Bev; n = 57) or mIFL+Bev (n = 60). With a median follow-up of 34.4 months, overall survival was significantly greater for patients who received FOLFIRI+Bev (median 28.0 months) when compared with mIFL+Bev (median, 19.2 months; P = .037; HR for death = 1.79; 95% CI, 1.12 to 2.88; Fig 1). The proportion of patients alive at 1-year was 87% for the FOLFIRI+Bev–treated group and 61% for mIFL+Bev.

View larger version (11K): [in this window] [in a new window] [PowerPoint Slide for Teaching]   Fig 1. Overall survival for period 2. FOLFIRI, infusional fluorouracil/leucovorin/irinotecan; mIFL, modified bolus irinotecan/fluorouracil/leucovorin.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: José Barrueco, Pfizer Inc (C) Consultant or Advisory Role: None Stock Ownership: None Honoraria: Charles S. Fuchs, Pfizer Oncology, Sanofi-aventis, Genentech, Bristol-Myers Squibb Co, Amgen, Imclone Systems Inc, Roche, AstraZeneca; John Marshall, Pfizer, Genentech, Bristol-Myers Squibb Co, Sanofi-aventis, Roche, Amgen, Boerhinger Ingelheim Research Funding: Charles S. Fuchs, Pfizer Expert Testimony: None Other Remuneration: None

REFERENCE

1. Fuchs CS, Marshall J, Mitchell E, et al: 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. J Clin Oncol 25:4779-4786, 2007[Abstract/Free Full Text]

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