A phase III trial demonstrated efficacy and safety of adding bevacizumab (Avastin) to standard neoadjuvant chemotherapy in patients with HER2-negative breast cancer.
A phase III trial demonstrated efficacy and safety of adding bevacizumab (Avastin) to standard neoadjuvant chemotherapy in patients with HER2-negative breast cancer. The ARTemis trial was developed in the United Kingdom (UK) and tested in 781 women who were recently diagnosed with breast cancer at an early stage.
Results of this trial were published in the June 2015 edition of The Lancet Oncology.1
Neoadjuvant bevacizumab, a monoclonal antibody, was added to docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (D-FEC) in the trial. Eight hundred women were recruited, but some additional diagnostic characteristics, such as metastasis or abnormal liver function levels, made several ineligible for this trial.
Patients at 66 centers in the UK were randomly assigned to 3 cycles of docetaxel (100 mg/m2 once every 21 days) followed by 3 cycles of fluorouracil (500 mg/m2), epirubicin (100 mg/m2), and cyclophosphamide (500 mg/m2) once every 21 days (D-FEC), with or without 4 cycles of bevacizumab (15 mg/kg, Bev+D-FEC).
Because of the risk of cardiac toxicity, researchers assessed left ventricular ejection fraction before treatment started and after 4 cycles of chemotherapy, with or without bevacizumab. If patients developed treatment-induced congestive heart failure (CHF), bevacizumab and epirubicin were discontinued and other chemotherapy was given at the discretion of the treating clinician.
Fewer patients with estrogen receptor (ER) strongly-positive breast cancer experienced pathological complete response (pCR) with 4 cycles Bev+D-FEC when compared to ER-negative and ER weakly-positive patients. In other words, ER-negative patients experienced an absence of invasive breast cancer in the breast and axillary lymph nodes.
Besides CR as a primary endpoint, secondary endpoints will be analyzed in early 2016 when it is anticipated that median follow-up will be at least 36 months or 120 disease-free survival events will have occurred.
Researchers expect that a meta-analysis of available neoadjuvant trials will help to define subgroups of early breast cancer that would have clinically significant long-term benefit from bevacizumab treatment.