Bevacizumab (BEV) with or after chemotherapy (CT) for platinum-resistant recurrent ovarian cancer (PROC): Exploratory analyses of the AURELIA trial.

Authors

null

Aristotelis Bamias

HECOG, University of Athens, Medical School, Athens, Greece

Aristotelis Bamias , Meletios A. Dimopoulos , Flora Zagouri , Anne-Sophie Veillard , Jens Kosse , Ana Santaballa , Mansoor Raza Mirza , Gianna Tabaro , Ignace Vergote , Haiko Bloemendal , Maria Lykka , Anne Floquet , Chee Lee , Val Gebski , Eric Pujade-Lauraine

Organizations

HECOG, University of Athens, Medical School, Athens, Greece, HECOG, General Peripheral Hospital of Athens, Athens, Greece, ANZGOG, NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia, AGO, Sana Klinikum Offenbach, Offenbach, Germany, GEICO, Clinical Area Breast Cancer and Gynecologic Oncology, Valencia, Spain, NSGO, Copenhagen University Hospital, Copenhagen, Denmark, MITO, USCC/Dir. Scientifica, Centro di Riferimento Oncologico, CRO-IRCCS, Aviano, Italy, BGOG, University Hospital Leuven, Leuven, Belgium, DGOG, Meander Medical Center, Amersfoort, Netherlands, GINECO, Institut Bergonié, Bordeaux, France, ANZGOG, NHMRC Clinical Trials Centre, Sydney, Australia, GINECO, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu, Paris, France

Research Funding

Other

Background: In the open-label randomized phase III AURELIA trial, adding BEV to CT for PROC significantly improved progression-free survival (hazard ratio [HR] 0.48; p < 0.001) and response rate (27% vs 12%) vs CT alone, but not overall survival (OS). Methods: Eligible patients (pts) had measurable/assessable OC that had progressed < 6 mo after platinum CT. After CT selection, pts were randomized to CT ± BEV until progression (PD), unacceptable toxicity or consent withdrawal. Crossover to BEV at PD was optional in the CT arm but prohibited in the BEV–CT arm. Exploratory post hoc analyses assessed factors potentially affecting the decision to crossover to BEV, and efficacy and safety according to post-PD BEV. Results: 179 pts were randomized to BEV–CT and 182 to CT alone. 72 pts (40%) in the CT-alone arm crossed over to BEV after PD and 110 never had BEV. There were no significant differences in pt characteristics between these subgroups at baseline but at the time of PD, 51% vs 35%, respectively, had ECOG performance status (PS) 0 (p = 0.034). 3-month landmark analyses, excluding 28 pts who died or were lost to follow-up before this time, showed significantly longer OS in pts who received BEV either with CT (HR 0.72, 95% CI 0.54–0.97) or after PD (HR 0.69, 95% CI 0.48–0.99) vs those who never received BEV. These differences remained significant after adjusting for identified prognostic factors for OS (chosen CT, platinum-free interval, ECOG PS, baseline ascites, baseline CA-125). When analyzed from the time of PD, the OS HR vs never BEV was 0.84 (95% CI 0.62–1.14) for upfront (pre-PD) BEV–CT and 0.55 (95% CI 0.38–0.79) for BEV after PD. Tolerability was similar with pre- vs post-PD BEV. Conclusions: There appears to be no clear difference in OS between upfront vs post-PD BEV therapy. Pts who never received BEV had the worst OS. These analyses of a non-randomized phase of the study with no information on other post-PD therapies do not allow definitive conclusions about upfront vs post-PD BEV efficacy. Nevertheless, as 60% of pts randomized to CT alone never received BEV, upfront treatment with BEV–CT is important, as reserving BEV until after PD may deny some pts the opportunity to benefit from BEV. Clinical trial information: NCT00976911

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT00976911

Citation

J Clin Oncol 33, 2015 (suppl; abstr 5551)

DOI

10.1200/jco.2015.33.15_suppl.5551

Abstract #

5551

Poster Bd #

109

Abstract Disclosures

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