Last Updated: June 09, 2005



NEW YORK (Reuters Health) - The combination of bevacizumab (Avastin),
fluorouracil, and leucovorin is effective in previously untreated
patients with metastatic colorectal cancer, according to a recent
report. "This is first direct test of the value of adding a
traditional cytotoxic versus adding a novel targeted agent on top of
a simplified platform of chemotherapy," Dr. Herbert I. Hurwitz told
Reuters Health.


Dr. Hurwitz from Duke University Medical Center in Durham, North
Carolina, and colleagues compared outcomes of 210 patients with
metastatic colorectal cancer treated either with the anti-VEGF
monoclonal antibody bevacizumab plus fluorouracil and leucovorin
(FU/LV/BV) or the combination of irinotecan, fluorouracil and
leucovorin (IFL).

The efficacy of the two regimens was similar, the investigators
report in the May 20th Journal of Clinical Oncology.

Median survival in patients treated with FU/LV/BV was 18.3 months,
the authors report, and in patients treated with IFL it was 15.1
months (p=0.25).

Median progression-free survival was also nonsignificantly higher in
patients treated with FU/LV/BV (8.8 months) than in patients treated
with IFL (6.8 months), the report indicates.

The percentage of patients with any grade 3 or 4 adverse event was
lower for FU/LV/BV (77.1%) than for IFL (81.6%), the results indicate.

A higher percentage of patients in the FU/LV/BV group had adverse
events causing withdrawal from the study and more FU/LV/BV patients
died from any cause within 60 days after randomization, the report
indicates, but adverse events leading to hospitalization occurred
with equal frequency in the two treatment arms.

"These data suggest modulating the targeted agents may be not only
less toxic, but may provide as much if not more anti-tumor activity
than adding cytotoxic agents," Dr. Hurwitz said. "This suggests one
approach to the development of new treatments will be to maximize
novel targeted agents upon a simplified chemotherapy platform."

This approach "needs clinical validation," Dr. Hurwitz
added. "Studies moving in this direction are now ongoing."





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