A phase II study of high-dose bevacizumab in combination with irinotecan, 5-fluorouracil, leucovorin, as initial therapy for advanced colorectal cancer: Results from the eastern cooperative oncology group study E2200

Bruce J. Giantonio, D. E. Levy, P. J. O'Dwyer, N. J. Meropol, P. J. Catalano, A. B. Benson

Research output: Contribution to journalArticlepeer-review

115 Scopus citations

Abstract

Aim: Patients with untreated advanced colorectal cancer were enrolled to this single arm phase II multi-center cooperative group trial of bevacizumab combined with IFL. The first 20 patients received irinotecan (125 mg/m2), 5-fluorouracil (500 mg/m2) and leucovorin (20 mg/m2) weekly for four of six weeks and high-dose bevacizumab (10 mg/kg) every other week. Following a toxicity review of other trials using IFL, subsequent patients were enrolled at reduced doses of irinotecan (100 mg/m2) and 5-fluorouracil (400 mg/m2). Results: Of the 92 patients accrued to the study, toxicity data are available for 87 patients and efficacy data for 81 patients. At a median follow-up of 37.5 months, median overall survival is 26.3 months, median progression free survival is 10.7 months and 1-year survival is 85%. The overall response rate is 49.4% (6.2% complete responses). A reduction in the starting doses of irinotecan and 5-fluorouracil decreased the occurrence of vomiting, diarrhea and neutropenia related complications. Bleeding occurred in 37 patients; all events but two were grade 1 or grade 2. There were nine reports of grade 3 or grade 4 thrombo-embolic events. Hypertension of any grade occurred in 13% of patients and proteinuria was infrequent. Conclusion: High-dose bevacizumab added to IFL is a well-tolerated and highly active regimen in patients with previously untreated metastatic colorectal cancer.

Original languageEnglish (US)
Pages (from-to)1399-1403
Number of pages5
JournalAnnals of Oncology
Volume17
Issue number9
DOIs
StatePublished - Sep 2006

Keywords

  • First-line therapy
  • High-dose bevacizumab
  • IFL
  • Metastatic colorectal cancer

ASJC Scopus subject areas

  • Hematology
  • Oncology

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