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

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

Research output: Contribution to journalArticle

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 patientreported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.

Original languageEnglish
Pages (from-to)1309-1316
Number of pages8
JournalJournal of Clinical Oncology
Volume32
Issue number13
DOIs
Publication statusPublished - May 1 2014

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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    Stockler, M. R., Hilpert, F., Friedlander, M., King, M. T., Wenzel, L., Lee, C. K., Joly, F., De Gregorio, N., Arranz, J. A., Mirza, M. R., Sorio, R., Freudensprung, U., Sneller, V., Hales, G., & Pujade-Lauraine, E. (2014). Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. Journal of Clinical Oncology, 32(13), 1309-1316. https://doi.org/10.1200/JCO.2013.51.4240