There is a great deal of interest in the adjuvant use of Avastin for breast cancer. Avastin is FDA approved with paclitaxel for metastatic breast cancer. FDA approved Avastin on 2/27/08 for first line treatment of metastatic cancer only. It is in several adjuvant studies; a phase II study ECOG 5103 has recently been suspended. This randomized phase III trial was studying doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer. It was suspended for review because there were 6 cases of CHF from the first 200 patients.
There are indications that adjuvant Avastin may not be effective in colon cancer where it is also being studied for adjuvant therapy. According to the results of a Phase III clinical trial, the addition of the targeted therapy Avastin® (bevacizumab) to post-surgery chemotherapy does not reduce the risk of cancer recurrence among patients with early-stage colon cancer. The current results are from a Phase III trial known as NSABP C-08. The study enrolled patients with Stage II or Stage III colon cancer. After surgical removal of the cancer, patients were assigned to receive adjuvant chemotherapy alone (mFOLFOX6) or adjuvant chemotherapy plus Avastin.
The results of the study indicate that the addition of Avastin to chemotherapy did not reduce the risk of cancer recurrence. The same may turn out to be the case for breast cancer.
nccn.org, Breast Cancer
Roche Media Release. Phase III C-08 study of Avastin in early-stage colon cancer does not meet primary endpoint. Available at: http://www.roche.com/media/media_releases/med-cor-2009-04-22.htm.