Independent radiologic review of AURELIA, a phase 3 trial of bevacizumab plus chemotherapy for platinum-resistant recurrent ovarian cancer.

Objective: The randomized, open-label, phase 3 Avastin® Use in Platinum-Resistant Epithelial Ovarian Cancer (AURELIA) trial achieved its primary efficacy end point of significantly improved progression-free survival (PFS) in patients treated with bevacizumab in combination with chemotherapy (CT) compared with CT alone for platinum-resistant, recurrent ovarian cancer. Primary analyses were conducted via investigator assessment of PFS; to confirm primary results, an independent review committee (IRC) retrospectively assessed radiographic data.

Methods: Per an amendment to the original study protocol, the IRC reviewed radiographic data from 298 (82.5%) patients in a blinded manner using the Response Evaluation Criteria in Solid Tumors (modified version 1.0). IRC-assessed PFS and concordance between the two assessments were evaluated.

Results: IRC assessment demonstrated that PFS was significantly prolonged for patients treated with CT+bevacizumab compared with CT alone (median, 8.1 vs. 3.9months; hazard ratio, 0.484; 95% confidence interval, 0.370-0.632; P<0.0001). Results were similar to the primary PFS analysis from investigator assessment (median, 6.8 vs. 3.4months; hazard ratio, 0.384; 95% confidence interval, 0.300-0.491; P<0.0001). Concordance rates for progressive disease status (CT+bevacizumab, 68.2%; CT, 69.9%) and date (CT+bevacizumab, 67.2%; CT, 69.1%) were similar across treatment arms. Among 161 IRC-evaluable patients declared to have progressive disease by investigator and IRC assessment, 68.3% progressed on the same date as determined by both investigator and IRC.

Conclusions: IRC assessment of PFS confirmed the investigator-assessed PFS improvement for patients treated with CT+bevacizumab compared with CT alone in the AURELIA study.