Health-related quality of life (HRQoL) results from the AURELIA trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum-resistant recurrent ovarian cancer (OC).

Authors

Martin Stockler

Martin R. Stockler

The University of Sydney, Sydney, Australia

Martin R. Stockler , Felix Hilpert , Michael Friedlander , Madeleine King , Lari B. Wenzel , Chee Lee , Florence Joly , Nikolaus De Gregorio , Jose Angel Arranz Arija , Mansoor Raza Mirza , Roberto Sorio , Ulrich Freudensprung , Vesna Sneller , Gill Hales , Eric Pujade Lauraine

Organizations

The University of Sydney, Sydney, Australia, AGO and Klinik für Gynäkologie und Geburtshilfe, Kiel, Germany, Prince of Wales Hospital, Sydney, Australia, University of California, Irvine, Irvine, CA, GINECO/Centre François Baclesse, Caen, France, AGO and University of Ulm Medical Center, Ulm, Germany, Hospital General Universitario Gregorio Marañón, Madrid, Spain, NSGO and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, MITO and Centro di Riferimento Oncologico-IRCCS, Aviano, Italy, F. Hoffmann-La Roche Ltd, Basel, Switzerland, GINECO/CHU Hotel Dieu, Paris, France

Research Funding

Pharmaceutical/Biotech Company

Background: Adding BEV to CT significantly improved PFS in platinum-resistant OC in the open-label phase III AURELIA trial. As symptom improvement is a major goal of treatment, determining effects on HRQoL was a key secondary aim of AURELIA. Methods: After investigator selection of single-agent CT (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel), patients (pts) with measurable/assessable platinum-resistant OC were randomized to CT ± BEV. HRQoL and symptoms were assessed at baseline and every 2 or 3 cycles (8/9 wks) until PD using the EORTC OC Module (OV28) and FOSI. The primary HRQoL endpoint was an absolute improvement of ≥15% (≥15 points) on the 100-point OV28 subscale for abdominal (abdo)/GI symptoms (items 1–6) at wk 8/9. Pts with missing questionnaires (Qs) were included and considered not to have improved. A sensitivity analysis excluded pts with Qs missing for reasons other than PD/death or switch from CT to BEV. Subgroup analyses of symptomatic pts included only those with a baseline score ≥15 (sufficient to show ≥15-point improvement). Mixed-model repeated measures (MMRM) analysis was used to compare Qs from all time points until PD/death, not just wk 8/9. The FOSI was analyzed similarly. Results: Baseline Qs were available from 89% of 361 randomized pts. At wk 8/9, 81% of BEV–CT vs 68% of CT pts who were alive and PD-free returned OV28 Qs. For the primary HRQoL endpoint, more BEV–CT than CT pts had a ≥15% improvement in the OV28 abdo/GI symptom subscale at wk 8/9 (21.9% vs 9.3%, 12.7% difference [95% CI 4.4–20.9]; p = 0.002). The sensitivity analysis described above showed a 13.3% difference [95% CI 4.5–22.1]. In the subgroup of 233 pts with a baseline score ≥15, there was a 16.9% difference (95% CI 6.1–27.6) favoring BEV–CT (29.6% vs 12.7%). MMRM analysis of OV28 abdo/GI symptom subscale scores also favored BEV–CT (6.4-point difference [95% CI 1.28–11.6]). More BEV–CT than CT pts had a ≥15% improvement in FOSI score at wk 8/9 (12.2% vs 3.1%, 9.0% difference [95% CI 2.9–15.2]). Conclusions: Adding BEV to CT resulted in more frequent ≥15% improvements in patient-reported abdo/GI symptoms in platinum-resistant OC. Clinical trial information: NCT00976911.

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Abstract Details

Meeting

2013 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 31, 2013 (suppl; abstr 5542)

DOI

10.1200/jco.2013.31.15_suppl.5542

Abstract #

5542

Poster Bd #

44F

Abstract Disclosures