Between May 2007 and June 2010, 944 patients were assigned chemotherapy treatment with epirubicin/cyclophosphamide followed by docetaxel; 945 patients were assigned this treatment plus bevacizumab.
After the first four cycles, the researchers performed an interim assessment; 24 percent of patients treated without bevacizumab and 17 percent of patients treated with bevacizumab showed no response and were discontinued from treatment.
Interim safety data from the trial, published earlier this year, indicated that treatment with bevacizumab was feasible. Patients assigned bevacizumab experienced more leukopenia, infections, mucositis and hypertension, but less edema. This safety profile is no different from that reported in first-line metastatic trials or Phase II adjuvant trials of bevacizumab, according to von Minckwitz.
Full results on the histological response and surgical outcome will be reported during the symposium.
"The results will provide an important signal as to whether bevacizumab will be effective as an adjuvant treatment," said von Minckwitz.
Source: American Association for Cancer Research