Independent radiologic review of AURELIA, a phase 3 trial of bevacizumab (BV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC).

5540^ Background: AURELIA is a phase 3, randomized, open-label trial in patients (pts) with PT-resistant, recurrent OC (NCT00976911). Based on investigator (INV) assessment of radiographic data, CT + BV showed significant improvement vs CT alone in the primary end point of progression-free survival (PFS) (Pujade-Lauraine, JCO in press). Median PFS was 3.4 months for CT vs 6.8 months for CT + BV (stratified hazard ratio [HR], 0.38; 95% confidence interval [CI], 0.30–0.49; P<.001). As this was an open-label trial, an independent review committee (IRC) assessment of radiologic data was conducted retrospectively to confirm these results. Methods: Radiologic images were provided to the IRC for 92.2% of randomized pts; 82.5% of pts were IRC-evaluable. Data were reviewed in a blinded manner according to a prespecified charter following modified RECIST v.1.0. PFS analysis was based on the intent-to-treat population. Results: IRC results were consistent with those from the INV, demonstrating a statistically signif...