AURELIA: A randomized phase III trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC).

Gynecologic Cancer
Session Type and Session Title: 
Oral Abstract Session, Gynecologic Cancer
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr LBA5002^)
Eric Pujade-Lauraine, Felix Hilpert, Béatrice Weber, Alexander Reuss, Andres Poveda, Gunnar Kristensen, Roberto Sorio, Ignace B. Vergote, Petronella Witteveen, Aristotelis Bamias, Deolinda Pereira, Pauline Wimberger, Ana Oaknin, Mansoor Raza Mirza, Philippe Follana, David T. Bollag, Isabelle Ray-Coquard, AURELIA Investigators; GINECO and Université Paris Descartes, Paris, France; AGO and Klinik für Gynäkologie und Geburtshilfe, Kiel, Germany; GINECO and Centre Alexis Vautrin, Vandoeuvre-les-Nancy, France; AGO and Coordinating Center for Clinical Trials, Marburg, Germany; GEICO and Instituto Valenciano de Oncologia, Valencia, Spain; NSGO and Norwegian Radium Hospital, Oslo, Norway; MITO and Centro di Riferimento Oncologico-IRCCS, Aviano, Italy; BGOG and University Hospital Leuven, Leuven, Belgium; DGOG and University Medical Center Utrecht, Utrecht, Netherlands; HECOG and University of Athens, Athens, Greece; GINECO and IPO-Porto, Porto, Portugal; AGO and Department of Gynecology and Obstetrics, University of Duisburg-Essen, Essen, Germany; GEICO and Vall d'Hebron University Hospital, Barcelona, Spain; NSGO-Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; GINECO and Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France; F. Hoffmann-La Roche Ltd., Basel, Switzerland; GINECO and Centre Léon Bérard, Lyon, France

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Abstract Disclosures


Background: In three phase III trials in OC (2 front line, 1 PT-sensitive recurrent), BEV + CT → BEV significantly improved progression-free survival (PFS) vs CT alone. AURELIA is the first randomized trial of BEV in PT-resistant OC. Methods: Eligible patients (pts) had OC (measurable by RECIST 1.0 or assessable) that had progressed ≤6 mo after ≥4 cycles of PT-based therapy. Pts with refractory OC, history of bowel obstruction, or >2 prior anticancer regimens were ineligible. After CT selection by the investigator (pegylated liposomal doxorubicin [PLD], topotecan [TOP], or weekly paclitaxel [PAC]), pts were randomized to CT either alone or with BEV (10 mg/kg q2w or 15 mg/kg q3w depending on CT) until progression (PD), unacceptable toxicity, or withdrawal of consent. Pts in the CT-alone arm could cross over to BEV monotherapy at PD. The primary endpoint was PFS by RECIST. Secondary endpoints included objective response rate (ORR), overall survival, safety, and quality of life. The design provided 80% power to detect a PFS hazard ratio (HR) of 0.7 with 2-sided log-rank test and α=0.05 after 247 events, assuming median PFS of 4.0 mo with CT and 5.7 mo with CT + BEV. Results: Between Oct 2009 and Apr 2011, 361 pts were randomized to receive selected CT (PLD: 126; PAC: 115; TOP: 120) alone or with BEV. Median follow-up after 301 PFS events was 13.5 mo. Conclusions: In PT-resistant OC, BEV + CT provides statistically significant and clinically meaningful improvement in PFS and ORR vs CT alone. Strict inclusion criteria minimized the incidence of BEV AEs. This is the first phase III trial in PT-resistant OC to show benefit with a targeted therapy and improved outcome with a combination vs monotherapy.
PFS by RECIST (N=182) (N=179)
Events, n (%) 166 (91) 135 (75)
HR (95% CI) 0.48 (0.38–0.60)
Log-rank p<0.001
Median, mo (95% CI) 3.4
ORR, % (95% CI) 12.6 (8.0–18.4) 30.9 (24.1–38.3)
Selected adverse events, % (N=181) (N=179)
Grade ≥2
Hypertension 7 20
Proteinuria 1 11
GI perforation 0 2
Fistula/abscess 0 2
Grade ≥3
Bleeding 1 1
Thromboembolic event
Reversible posterior leukoencephalopathy 0 1
Febrile neutropenia 1 1
Congestive heart failure 1 1