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| |  Bevacizumab Plus Docetaxel Improves Progression-Free Survival, but Not Overall Survival in Metastatic Breast Cancer: Presented at SABCS By Wayne Kuznar SAN ANTONIO, Tex -- December 14, 2009 -- Bevacizumab combined with docetaxel as first-line therapy for locally recurrent or metastatic breast cancer is superior to docetaxel alone in progression-free survival (PFS) and overall recurrence rate, but overall survival is not changed by adding bevacizumab. The final analysis of the double-blind, placebo-controlled, phase 3 Bevacizumab Plus Docetaxel in Metastatic Breast Cancer (AVADO) trial was announced here on December 11 at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). In the study, 736 patients with human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer, and no central nervous system metastases, were randomised to first-line treatment with docetaxel 100 mg/m2 once every 3 weeks for up to 9 cycles plus placebo or docetaxel plus either bevacizumab 7.5 mg/kg or 15 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. Patients randomised to placebo were given the option to cross over to bevacizumab with second-line chemotherapy if they experienced disease progression. The data cutoff for the final analysis was April 2009, for a median follow-up of 25 months. In the stratified PFS endpoint, patients were censored if they had started nonprotocol therapy before disease progression. This endpoint was improved by 20% (P = .0450) with the 7.5-mg/kg dose of bevacizumab (from 8.1 to 9.0 months) and by 33% (P = .0002) with the 15-mg/kg dose (from 8.1 to 10 months). The overall response rates were 46.4% in the placebo plus docetaxel group; 55.2% with bevacizumab, 7.5 mg/kg plus docetaxel (P = .0739); and 64.1% with bevacizumab 15 mg/kg, with docetaxel (P = .0003). “There was no impact on survival with either of the bevacizumab dosages,” said David W. Miles, MD, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom. The median overall survival was 31.9 months in the placebo plus docetaxel group; 30.8 months with bevacizumab 7.5 mg/kg plus docetaxel; and 30.2 months with bevacizumab, 15 mg/kg plus docetaxel. The lack of an observable effect of bevacizumab on overall survival reflects a multitude of treatment options beyond bevacizumab, in addition to the large number of patients who crossed over to bevacizumab, noted Dr. Mills. About 50% of patients had crossed over due to disease progression. “In clinical trials of first-line treatment of metastatic breast cancer, it is relatively unusual to demonstrate a survival difference,” he said. “The principal reason for that is we’re modifying the disease course in a relatively short time. Thankfully, these women in this trial were seeing median survivals above 30 months. That’s really reflecting that there are a lot of other treatment options beyond that first progression.” Bevacizumab had limited impact on the known safety profile of docetaxel. [Presentation title: Final Overall Survival (OS) Results From the Randomised, Double-Blind, Placebo-Controlled, Phase III AVADO Study of Bevacizumab (BV) Plus Docetaxel (D) Compared With Placebo (PL) Plus D for the First-Line Treatment of Locally Recurrent (LC) or Metastatic Breast Cancer (mBC). Abstract 41]
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