Statistically significant improvement seen in Independent Review Committee assessment
THURSDAY, Dec. 8 (HealthDay News) -- For patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent/metastatic breast cancer (LR/mBC), the addition of bevacizumab (BEV) to trastazumab (H) and docetaxel (DOC) 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 Dec. 6 to 10.
Luca Gianni, M.D., Ph.D., from Ospedale San Raffaele in Milan, Italy, and colleagues investigated the efficacy of H + DOC compared with H + DOC + BEV, 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 H + DOC (208 participants) or H + DOC + BEV (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 H + DOC group and 153 in the H + DOC + BEV group (74 and 71 percent, respectively; hazard ratio [HR] on unstratified analysis, 0.82; 95 percent confidence interval, 0.65 to 1.02). The median PFS was significantly increased in the group with adjuvant BEV (16.5 versus 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 BEV-containing therapy for HER2-positive LR/mBC," the authors write.