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Annals of Oncology Advance Access published online on July 27, 2006
Annals of Oncology, doi:10.1093/annonc/mdl161
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© 2006 European Society for Medical Oncology
Received June 5, 2006
Accepted June 7, 2006

original article

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

B. J. Giantonio 1 *, D. E. Levy 2, P. J. O'Dwyer 1, N. J. Meropol 3, P. J. Catalano 2, and A. B. Benson III 4

1 University of Pennsylvania, Philadelphia, PA, USA
2 Dana-Farber Cancer Institute, Boston, MA, USA
3 Fox Chase Cancer Center, Philadelphia, PA, USA
4 Northwestern University, Chicago, IL, USA

* To whom correspondence should be addressed.
B. J. Giantonio, E-mail: giantonio.bruce{at}jimmy.harvard.edu


  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.

Keywords: first-line therapy; high-dose bevacizumab; IFL; metastatic colorectal cancer.
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