TY - JOUR
T1 - Independent radiologic review of AURELIA, a phase 3 trial of bevacizumab plus chemotherapy for platinum-resistant recurrent ovarian cancer
AU - Husain, Amreen
AU - Wang, Yan
AU - Hanker, Lars C.
AU - Ojeda, Belén
AU - Anttila, Maarit
AU - Breda, Enrico
AU - Vuylsteke, Peter
AU - Pujade-Lauraine, Eric
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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. 3.9 months; 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. 3.4 months; 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.
AB - 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. 3.9 months; 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. 3.4 months; 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.
UR - http://www.scopus.com/inward/record.url?scp=84977530161&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2016.05.011
DO - 10.1016/j.ygyno.2016.05.011
M3 - Journal articles
C2 - 27184721
AN - SCOPUS:84977530161
SN - 0090-8258
VL - 142
SP - 465
EP - 470
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 3
ER -