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Higher Dose of Bevacizumab Safe and Effective as Addition to Colorectal Cancer Chemotherapy: Presented at ASCO-GI

By Roberta Friedman, PhD

SAN FRANCISCO, CA -- January 26, 2004 -- Independent confirmation of the safety and efficacy of bevacizumab as an addition to chemotherapy for advanced colorectal cancer, was reported here January 24^th at the First Annual Gastrointestinal Cancers Symposium, sponsored jointly by the American Society of Clinical Oncology and other societies.

The Phase II trial, which has enrolled 90 patients so far, is testing a 10-mg/kg dose of the agent in combination with irinotecan, 5-fluorouracil (5-FU), and leucovorin. Median survival has not yet been reached, said study investigator Bruce Giantonio, University of Pennsylvania, Philadelphia, who presented the poster.

After the trial started, investigators decided to lower the dose of chemotherapy due to reports of deaths on other trials, Dr. Giantonio said in an interview. Despite the lower chemotherapy dose, and the higher dose of antibody used compared to the Genentech-sponsored Phase III study, survival appears to be good, and toxicities manageable, he said.

All but four of 47 bleeding events were Grade 1. Rates of Grades 3 and 4 toxicities did not differ between the two chemotherapy doses. Thrombosis occurred 11 times during the trials so far (87 patients provide toxicity results for the report). The dose of antibody is twice that reported earlier, Dr. Giantonio noted.

Median follow up of 16.7 months has yielded five complete responses and 35 partial responses.

The first 20 patients received 125 mg/m² CPT-11, 500 mg/m² 5-FU, and 20 mg/m² of leucovorin. Starting doses of the first two chemotherapy agents were then reduced to 100 mg/m² and 400 mg/m², respectively.

Genentech did not fund the study, carried out by the Eastern Cooperative Oncology Group. Dr. Giantonio has served as an advisor to the company and received honoraria.


[Study title: Bevacizumab (anti-VEGF) plus irinotecan, fluorouracil, leucovorin) as front-line therapy for advanced colorectal cancer (advCRC): Updated results from the Eastern Cooperative Oncology Group (ECOG) Study E2200. Abstract P289]

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