Avastin bevacizumab: Phase III data

Researchers at the German Breast Group and colleagues reported data from 1,948 previously untreated HER2-negative breast cancer patients in the open-label, German Phase III GeparQuinto showing that a significantly greater proportion of patients receiving Avastin plus chemotherapy (epirubicin plus cyclophosphamide and docetaxel) achieved a pCR, the primary endpoint, vs. chemotherapy alone (18.4% vs. 14.9%, p=0.04). Furthermore, a subgroup analysis showed that pCRs were primarily restricted to patients with hormone-receptor-negative tumors. Specifically, in patients with triple-negative tumors, Avastin plus chemotherapy led to a pCR rate of 39.3% vs. 27.9% for chemotherapy alone (n=663; p=0.003), while there was no significant difference in pCR rate between treatment arms in patients with hormone-receptor-positive tumors (n=1,262; 7.7% vs. 7.8%, p=1.0). Data were published in the New England Journal of Medicine.

The GeparQuinto trial evaluated neoadjuvant chemotherapy in combination with Avastin, Afinitor everolimus or Herceptin trastuzumab/ Tykerb lapatinib in 3 distinct populations of breast cancer patients. Last month, data from 615 evaluable previously untreated HER2-positive advanced breast cancer patients showed that a significantly greater proportion of patients receiving Herceptin plus chemotherapy achieved a pCR vs. Tykerb plus chemotherapy (30.3% vs. 22.7%, p=0.04) (see BioCentury, Jan. 23). The Afinitor arm enrolled patients with HER2-negative breast cancer who showed no sonographic response to 4 cycles of chemotherapy. ...