Format

Send to

Choose Destination
J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.

Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer.

Author information

1
Martin R. Stockler, Madeleine T. King, Chee Khoon Lee, The University of Sydney; Michael Friedlander, Prince of Wales Clinical School, University of New South Wales, Sydney, Australia; Felix Hilpert, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe, Kiel; Nikolaus de Gregorio, AGO and University of Ulm Medical Center, Ulm, Germany; Lari Wenzel, University of California Irvine, Irvine, CA; Florence Joly, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Centre François Baclesse, Caen; Eric Pujade-Lauraine, GINECO and Centre Hospitalier Universitaire Hotel Dieu, Paris, France; José Angel Arranz, Grupo Español de Investigación en Cáncer de Ovario and Hospital General Universitario Gregorio Marañón, Madrid, Spain; Mansoor Raza Mirza, Nordic Society of Gynaecological Oncology and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Roberto Sorio, Multicenter Italian Trials in Ovarian Cancer and Centro di Riferimento Oncologico-Istituto di Ricovero e Cura a Carattere Scientifico, Aviano, Italy; and Ulrich Freudensprung, Vesna Sneller, Gill Hales, F. Hoffmann-La Roche, Basel, Switzerland.

Abstract

PURPOSE:

To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial.

PATIENTS AND METHODS:

Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data.

RESULTS:

Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions.

CONCLUSION:

Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00976911.

PMID:
24687829
PMCID:
PMC4876313
DOI:
10.1200/JCO.2013.51.4240
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center