An interim analysis of a Phase III study of Bevacizumab ( Avastin ) plus Paclitaxel chemotherapy in first-line metastatic breast cancer showed an improvement in progression-free survival, compared to chemotherapy alone.

This Phase III study was a randomized, controlled, multicenter trial that enrolled 722 women with previously untreated metastatic breast cancer.
The patients enrolled in this trial were randomized to receive treatment with Paclitaxel with or without Bevacizumab.

Patients with HER2-positive metastatic breast cancer were not enrolled in the study unless they had received prior treatment with Trastuzumab ( Herceptin ) or were unable to receive treatment with Trastuzumab.
Patients who had received adjuvant Paclitaxel within the previous 12 months and patients with a prior history of blood clots or who were receiving blood thinners were also excluded from the study.

Adverse events in this study appeared to be similar to those observed in previous clinical trials with Bevacizumab in combination with chemotherapy in metastatic breast cancer.

Adverse events that occurred more often in the Bevacizumab arm included neuropathy, hypertension and proteinuria.
Serious bleeding and blood clots were rare in this study.
Additional adverse events were similar between the two treatment arms.

The trial was sponsored by the National Cancer Institute ( NCI ), part of the National Institutes of Health, under a Cooperative Research and Development Agreement between NCI and Genentech, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group ( ECOG ).

Bevacizumab is a therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor ( VEGF ), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels.
By binding to VEGF, Bevacizumab is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis.

Source: Genentech, 2005


XagenaMedicine2005