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AURELIA: A randomized phase III trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC).
Session Type and Session Title:
Oral Abstract Session, Gynecologic Cancer
J Clin Oncol 30, 2012 (suppl; abstr LBA5002^)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
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.
|CT||BEV + CT|
|PFS by RECIST||(N=182)||(N=179)|
|Events, n (%)||166 (91)||135 (75)|
|HR (95% CI)||0.48 (0.38–0.60)
|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)|
|Reversible posterior leukoencephalopathy||0||1|
|Congestive heart failure||1||1|
Abstracts by Eric Pujade-Lauraine:
Avelumab (MSB0010718C; anti-PD-L1) ± pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer: The phase III JAVELIN Ovarian 200 trial.Meeting: 2016 ASCO Annual Meeting | Abstract No: TPS5600
PAOLA-1: An ENGOT/GCIG phase III trial of olaparib versus placebo combined with bevacizumab as maintenance treatment in patients with advanced ovarian cancer following first-line platinum-based chemotherapy plus bevacizumab.Meeting: 2016 ASCO Annual Meeting | Abstract No: TPS5607
Phase I results of GANNET53: A multicenter phase I/II trial of the Hsp90 inhibitor ganetespib (G) combined with weekly paclitaxel (P) in women with high-grade serous, high-grade endometrioid, or undifferentiated, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.Meeting: 2016 ASCO Annual Meeting | Abstract No: e17038
Presentations by Eric Pujade-Lauraine:
CALYPSO Trial: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in relapsed platinum-sensitive ovarian cancerMeeting: 2009 ASCO Annual Meeting Abstract No: LBA5509Session: Gynecologic Cancer (Oral Abstract Session)