Safety of surgery in patients (pts) with locally recurrent (LR) or metastatic breast cancer (mBC) treated with docetaxel (D) plus bevacizumab (BV) or placebo (PL) in the AVADO phase III study

Abstract #1030 Background: The monoclonal antibody BV (Avastin®) specifically inhibits the biological activity of VEGF to disrupt tumour angiogenesis. The addition of BV to first-line taxane chemotherapy (CTx) increased clinical benefit in two randomised phase III studies of pts with LR or mBC, E2100 and AVADO. It is hypothesised that VEGF is essential for wound-healing, so it is recommended that BV therapy is interrupted prior to surgery and not restarted until the wound is fully healed. Incidence of wound-healing complications and bleeding events was investigated in pts undergoing surgery during the AVADO study. Methods: Pts with HER2-negative, inoperable LR or mBC, no CTx 6 months prior to randomisation (12 months if taxane-based), ECOG PS 0–1, adequate LVEF were randomised to BV (7.5 or 15mg/kg q3w) + D (100mg/m2 q3w for ≤9 cycles) or PL + D until disease progression or unacceptable toxicity. Safety of BV was evaluated in pts undergoing surgery. Major surgery was defined as any surgery requiring opening of a body cavity or more than local anaesthesia. Results: 42 surgical procedures were performed on the ITT population of 736 pts; ranging from minimally invasive procedures to major operations. The number of surgical events was similar in each study arm (PL: 17, BV 7.5mg/kg: 17, BV 15mg/kg: 8). Bleeding and wound-healing events reported in these pts after the date of surgery are presented below. Conclusions: This is the first analysis of the safety of surgery in pts with LR or mBC receiving BV. Treatment with BV + D did not affect the number of pts undergoing surgery. No effect of BV therapy was seen on the frequency of grade 3–5 bleeding and wound-healing adverse events in these pts. BV therapy was interrupted for longer periods pre- and post-major surgery, which may explain why bleeding and wound-healing adverse events are not increased in pts undergoing these procedures. Larger studies are required to obtain a more accurate picture of the safety of surgery in advanced breast cancer pts treated with BV. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1030.