AURELIA A randomized phase III trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC)

SUMMARY: AURELIA is a multicenter, randomized, open-label, two-arm Phase III study in which 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer were enrolled. These patients had disease progression within six months of their platinum based chemotherapy. Patients were randomly assigned to receive AVASTIN® (Bevacizumab) in combination with chemotherapy which included weekly paclitaxel, topotecan or pegylated liposomal doxorubicin or chemotherapy alone. The primary end point was Progression Free Survival. There was a 52% reduction in the risk of progression in those who received AVASTIN® plus chemotherapy compared to those who received chemotherapy alone (HR=0.48, P<0.001). Further, there was a significantly higher objective response rate in the AVASTIN® group compared to those who received chemotherapy alone (30.9 percent vs. 12.6 percent, p=0.001). Pujade-Lauraine E, Hilpert F, Weber B, et al. J Clin Oncol 30, 2012 (suppl; abstr LBA5002)