title: Independent radiologic review of AURELIA, a phase 3 trial of bevacizumab plus chemotherapy for platinum-resistant recurrent ovarian cancer.
abstract: 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.
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA. Electronic address: ahusain@stanford.edu.
authors.forename: Amreen
authors.initials: A
authors.lastname: Husain
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: AGO, Universitätsklinikum Schleswig-Holstein, Luebeck, Germany.
authors.forename: Lars C
authors.initials: LC
authors.lastname: Hanker
authors.affiliation: GEICO, Hospital de Sant Pau, Barcelona, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Ojeda
authors.affiliation: NSGO, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Maarit
authors.initials: M
authors.lastname: Anttila
authors.affiliation: MITO, Ospedale San Giovanni Calibita - Fatebenefratelli, Rome, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Breda
authors.affiliation: BGOG, Clinique et Maternité Sainte Elisabeth, Namur, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: Vuylsteke
authors.affiliation: GINECO, Université Paris Descartes, AP-HP, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D009375:Neoplasms, Glandular and Epithelial / Q000000981:diagnostic imaging / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D019772:Topotecan / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D009944:Organoplatinum Compounds; C506643:liposomal doxorubicin; D000068258:Bevacizumab; D011092:Polyethylene Glycols; D019772:Topotecan; D004317:Doxorubicin; D017239:Paclitaxel
keywords: AURELIA; Bevacizumab; Independent radiologic review; Ovarian cancer