(HealthDay News) – For patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent/metastatic breast cancer (LR/mBC), the addition of bevacizumab to trastazumab and docetaxel is associated with an increase in progression-free survival (PFS), according to a study presented at the annual San Antonio Breast Cancer Symposium, held from December 6 to 10.
Luca Gianni, MD, PhD (of Ospedale San Raffaele in Milan, Italy) and colleagues investigated the efficacy of trastazumab + docetaxel compared with trastazumab+ docetaxel + bevacizumab, in the first randomized trial in HER2-positive LR/mBC. A total of 424 eligible patients, enrolled from 60 centers between September 2006 and February 2010, were randomly allocated to receive trastazumab + docetaxel (208 participants) or trastazumab + docetaxel + bevacizumab (216 participants). The primary end point measured was PFS. Patients from both treatment groups were followed for a median of 26 months.
The investigators found that there were 154 events in the trastazumab + docetaxel group and 153 in the trastazumab + docetaxel + bevacizumab group (74% and 71%, respectively; hazard ratio [HR] on unstratified analysis, 0.82; 95% CI, 0.65–1.02). The median PFS was significantly increased in the group with adjuvant bevacizumab (16.5 vs. 13.7 months; HR in stratified analysis, 0.76). In an Independent Review Committee assessment, stratified and censored for non-protocol therapy, PFS was 16.8 and 13.9 months, respectively; HR for PFS events, 0.72.
“The improvement as assessed by Independent Review Committee was statistically significant. Evaluation of biomarkers is ongoing to try to identify those patients who may benefit from first-line bevacizumab-containing therapy for HER2-positive LR/mBC,” the authors write.