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Bevacizumab (Avastin) Demonstrates Trend Toward Survival in Metastatic Colorectal Cancer: Presented at AACR

By Peggy Peck

WASHINGTON, DC -- July 15, 2003 -- The second chapter in the bevacizumab (Avastin™) "good news" story is not as robust as the first installment: Third-arm results suggest a "trend toward improved survival" rather than demonstrated benefit in treatment-naïve patients with metastatic colorectal cancer.

Judah Folkman, MD, director of surgical research at Children's Hospital and Andrus Professor of Pediatric Surgery and Professor of Cell Biology, Harvard Medical School, in Boston, Massachusetts, United States, chaired a press briefing here July 14^th during the 94^th Annual Meeting of the American Association for Cancer Research.

"The primary experimental arms of the study compared the addition of the antiangiogenesis agent Avastin to the standard of care chemotherapy (Saltz regimen), irinotecan/5-fluorouracil/leucovorin (IFL). 403 patients were randomized to receive Avastin vs 412 who received the Saltz regimen plus placebo. Initially, 110 patients were randomized to a third arm of the study in which they received Avastin plus 5FU/leucovorin (5FU/LV). This third arm was discontinued at a prespecified safety analysis when it was demonstrated that the addition of Avastin to IFL did not significantly increase toxicity compared to IFL plus placebo.

The latest results presented by Dr. Hurwitz at AACR were based on the results obtained in the 110 patients who received Avastin plus 5-FU/LV, which were compared to previous results in 101 patients randomized to IFL plus Avastin and a further 101 patients randomized to IFL plus placebo "during the time that the third arm was recruiting patients." (The third arm was dropped, as prespecified, once safety of the IFL regimen was established.)

Median survival for Avastin plus 5-FU/LV patients was 18.3 months compared to 15.6 months for patients treated with IFL and placebo. Median survival for patients randomized to IFL plus Avastin was 20.3 months, a statistically significant increase over IFL plus placebo."

Results from the IFL/placebo and IFL/BV arms were reported June 1^st at the American Society of Clinical Oncology (ASCO) meeting in Chicago, where principal investigator Herbert I. Hurwitz of Duke University, Durham, North Carolina, United States, said that, taken together, the results of the multicenter study "suggest a proof of principal for the use of antiangiogenesis therapy in this disease."

Dr. Folkman concurred, saying in an interview that the Avastin results "are clearly a proof of principle." He added that he expects more positive results to follow quickly. Within days of the ASCO presentation, the National Cancer Institute in Maryland, United States, announced plans for an open-label trial to evaluate Avastin in patients with metastatic colorectal cancer.

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