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Bevacizumab Improves Survival Among All Colorectal Cancer Subgroups: Presented at CFS

By Charlene Laino

NEW YORK CITY -- November 15, 2004 -- The phase 3 clinical trial upon which the US Food and Drug Administration largely based its approval of bevacizumab for the treatment of colorectal cancer (CRC) shows that the humanized monoclonal antibody works equally well regardless of age, sex, performance status, or disease spread.

Heinz-Josef Lenz, MD, associate professor of medicine and preventive medicine, University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, said that the findings indicate "a unique mechanism in which increased efficacy is not dependent on any known clinical or pathological parameter."

Dr. Lenz presented the study here on November 10th at the Chemotherapy FOUNDATIONS Symposium XXII: Innovative Cancer Therapy for Tomorrow.

In the study, 813 patients with previously untreated metastatic colorectal cancer were randomized to receive the Saltz regimen (irinotecan, 5-fluorouracil, and leucovorin [IFL]) plus bevacizumab or placebo.

Overall, the 402 patients who received IFL plus bevacizumab survived a median of 20.3 months while the 411 patients on IFL plus placebo had a median survival of 15.6 months, corresponding to a hazard ratio (HR) of 0.66 (P <.001).

Among the 271 patients aged 65 years or older, those who received IFL plus bevacizumab survived a median of 24.2 months while those on IFL plus placebo had a median survival of 14.6 months (HR 0.60), Dr. Lenz reported. Among the 485 patients who were male, median survival times were 21.2 months and 15.4 months in the bevacizumab and control arms, respectively (HR 0.63), he said.

Similarly, among the 352 patients whose performance status was 1, median overall survival was 24.2 months in the bevacizumab arm, compared with 14.9 months in the placebo arm (HR 0.69). And among the 507 patients whose disease had metastasized to more than 1 site, median survival times were 19.9 months in the bevacizumab arm versus 14.6 months in the control arm (HR 0.62). All the values were statistically significant, Dr. Lenz said.

"[Vascular endothelial growth factor] and its receptors are very important targets for anticancer therapy," Dr. Lenz said. Agents, such as bevacizumab, which target this pathway, can be used safely in combination with other cytotoxic agents, he said.

Genentech and Roche helped fund the research.


[Presentation title: Angiogenesis Inhibitors in Colorectal Cancer. Abstract 23]

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