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| |  Adding Bevacizumab to Second-Line Chemo Improves Progression-Free Survival in Metastatic Breast Cancer: Presented at SABCS By Wayne Kuznar SAN ANTONIO, Tex -- December 12, 2009 -- Adding bevacizumab to second-line chemotherapy improves progression-free survival (PFS) in patients with human epidermal growth factor receptor 2 (HER 2)-negative metastatic breast cancer, researchers reported here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Bevacizumab has already been shown to improve progression-free survival when combined with first-line chemotherapies in the treatment of metastatic breast disease, but studies on its effect when combined with second-line chemotherapy regimens are lacking, explained Adam Brufsky, MD, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, on December 11. The international, double-blind, phase 3 study of Chemotherapy With or Without Bevacizumab for Second-Line Treatment of HER2-Negative Locally-Recurrent or Metastatic Breast Cancer (RIBBON 2) included 684 patients with histologically confirmed metastatic breast cancer. Patients had either HER 2-negative tumours (approximately 85% of the study population) or the HER-2 status was unknown. The effect of adding bevacizumab to either paclitaxel plus docetaxel, gemcitabine or vinorelbine, as chosen by the investigator, was assessed and compared with the addition of a placebo to these second-line chemotherapy agents. There was a 28% improvement in the primary endpoint of median PFS in patients randomised to bevacizumab compared with placebo (P =.0072). Median PFS was 7.2 months in the bevacizumab group compared with 5.1 months in the placebo group. The objective response rates were 39.5% in the patients assigned to bevacizumab compared with 29.6% in those assigned to placebo (P =.0193). Overall survival did not differ significantly between the 2 groups. Median overall survival was 18.0 months in the bevacizumab group and 16.4 months in the placebo group. The difference in survival is a “mean across the population -- certain people do far better and others do far worse,” explained Dr. Brufsky. “The bottom line is that there is a detectable benefit [with bevacizumab] but we don’t know about individual patients.” He emphasised that women in RIBBON 2 were heavily pretreated and in need of further treatment options when first-line therapies fail to control their disease. Use of bevacizumab throughout the entire course of metastatic disease should be assessed, he noted. No new safety signals with bevacizumab were observed in RIBBON 2, and adverse events were similar to those previously reported in studies of bevacizumab in advanced breast cancer and other indications. [Presentation title: RIBBON-2: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial Evaluating the Efficacy and Safety of Bevacizumab In Combination with Chemotherapy for Second-Line Treatment of HER2-Negative Metastatic Breast Cancer. Abstract #42]
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