Amreen Husain1, Yan Wang2, Lars C Hanker3, Belén Ojeda4, Maarit Anttila5, Enrico Breda6, Peter Vuylsteke7, Eric Pujade-Lauraine8. 1. Genentech, Inc., South San Francisco, CA, USA. Electronic address: ahusain@stanford.edu. 2. Genentech, Inc., South San Francisco, CA, USA. 3. AGO, Universitätsklinikum Schleswig-Holstein, Luebeck, Germany. 4. GEICO, Hospital de Sant Pau, Barcelona, Spain. 5. NSGO, Kuopio University Hospital, Kuopio, Finland. 6. MITO, Ospedale San Giovanni Calibita - Fatebenefratelli, Rome, Italy. 7. BGOG, Clinique et Maternité Sainte Elisabeth, Namur, Belgium. 8. GINECO, Université Paris Descartes, AP-HP, Paris, France.
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 withbevacizumab 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 withCT+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 withCT+bevacizumab compared with CT alone in the AURELIA study.
RCT Entities:
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: Gerald Falchook; Robert L Coleman; Andrzej Roszak; Kian Behbakht; Ursula Matulonis; Isabelle Ray-Coquard; Piotr Sawrycki; Linda R Duska; William Tew; Sharad Ghamande; Anne Lesoin; Peter E Schwartz; Joseph Buscema; Michel Fabbro; Alain Lortholary; Barbara Goff; Razelle Kurzrock; Lainie P Martin; Heidi J Gray; Siqing Fu; Emily Sheldon-Waniga; Huamao Mark Lin; Karthik Venkatakrishnan; Xiaofei Zhou; E Jane Leonard; Russell J Schilder Journal: JAMA Oncol Date: 2019-01-10 Impact factor: 31.777
Authors: Andrew Embleton-Thirsk; Elizabeth Deane; Stephen Townsend; Laura Farrelly; Babasola Popoola; Judith Parker; Gordon Rustin; Matthew Sydes; Mahesh Parmar; Jonathan Ledermann; Richard Kaplan Journal: Clin Trials Date: 2019-07-26 Impact factor: 2.486