Researchers from Europe reported results from the AVEDO trial, which indicated that the addition of Avastin® (bevacizumab) to Taxotere® (docetaxel) improves progression-free survival compared with Taxotere alone in metastatic HER2-negative breast cancer. Furthermore, higher doses of Avastin resulted in improved progression-free survival. These results were recently reported as a late-breaking abstract at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO).

Avastin is currently approved for the treatment of HER2-negative, metastatic breast cancer in combination with Taxol® (paclitaxel), and has demonstrated improved progression-free survival with Taxol. The potential efficacy of Avastin in addition to Taxotere, however, has not yet been evaluated.

A multinational Phase III clinical trial was conducted to evaluate the addition of Avastin to Taxotere among 736 patients with locally recurrent or metastatic HER2-negative breast cancer who had not receive prior therapy for metastatic disease. All patients were treated with Taxotere (100 mg/m2) for nine cycles and were then randomized to Avastin (7.5 or 15 mg/kg) until progression or placebo. The trial was not intended to compare the different doses of Avastin, so statistical analysis between the two arms became “statistically difficult.” Median follow-up was approximately one year.

• Progression-free survival (PFS) was improved by 30- 40% among patients treated with Avastin/Taxotere compared with Taxotere alone.
• In stratified analysis, the hazard ratio was 0.69 (P=0.0035) for the lower-dose Avastin arm and 0.61 (P=0.0001) for the higher-dose Avastin arm in terms of PFS compared with the placebo arm.
• In unstratified analysis, the hazard ratio was 0.79 (P=0.0138) for the lower-dose Avastin arm and 0.72 (P=0.0099) for the higher-dose Avastin arm in terms of PFS compared with the placebo arm.
• In a preliminary analysis of overall survival, a secondary endpoint of the study, there was a nonsignificant improvement of 8% and 32%, respectively, among the lower-dose and higher-dose Avastin arms compared with placebo.
• There were no new or unexpected toxicity issues reported from any arm of the study.

Comments: The researchers concluded that the addition of Avastin to Taxotere improves progression-free survival in locally recurrent or metastatic HER2-negative breast cancer, particularly at a dose of 15 mg/m2, which is the approved dose in the United States to be used with Taxol in breast cancer.

Related News:

FDA Approves Avastin® (Bevacizumab) for Breast Cancer (02/25/2008)

Avastin® Evaluated in Patients with Advanced or Metastatic Breast Cancer (01/09/2008)

Avastin® (Bevacizumab) and Taxol® (Paclitaxel) Improves Progression-Free Survival in Metastatic Breast Cancer (01/07/2008)

Reference: Miles D, et al. Randomized, double-blind, placebo-controlled phase III study of bevacizumab (BV) with docetaxel (D) or docetaxel with placebo (PL) as first-line therapy for patients wit locally recurrent or metastatic breast cancer (mBC): AVADO. ASCO Meeting 2008; Abstract LBA1011.