Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial

Roberto Sorio, Célia Roemer-Becuwe, Felix Hilpert, Emma Gibbs, Yolanda García, Janne Kaern, Manon Huizing, Petronella Witteveen, Flora Zagouri, David Coeffic, Hans Joachim Lück, Antonio González-Martín, Gunnar Kristensen, Charles Briac Levaché, Chee Khoon Lee, Val Gebski, Eric Pujade-Lauraine

Research output: Contribution to journalArticle

Abstract

Background The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC). Methods Patients with PROC were randomised to receive investigator-selected single-agent chemotherapy alone or with bevacizumab. Post-hoc exploratory analyses assessed efficacy, safety and patient-reported outcomes according to age < 65 versus ≥ 65 years. Results In the 133 patients (37%) aged ≥ 65 years, baseline hypertension was more frequent and ascites was less common than in patients < 65 years. The magnitude of PFS benefit from bevacizumab was similar in patients ≥ 65 versus < 65 years (hazard ratio 0.44 [95% CI, 0.31–0.64] versus 0.49 [95% CI, 0.37–0.64], respectively, treatment–age interaction p = 0.58), with similar improvements in response rates. Grade ≥ 3 hypertension was more common with bevacizumab than chemotherapy alone in both subgroups, and more common in older than younger patients irrespective of treatment. However, there was no excess of other adverse events of specific interest for bevacizumab, including venous thromboembolic events, in older patients. More patients receiving bevacizumab in the younger but not the older subgroup showed improved gastrointestinal/abdominal symptoms. Conclusion In exploratory analyses, PFS and response rate improvement with bevacizumab were consistent in older and younger patients. Grade ≥ 3 hypertension was more common in elderly bevacizumab-treated patients; careful monitoring is recommended. Overall, bevacizumab-containing therapy was well tolerated in a selected population aged ≥ 65 years, suggesting a favourable benefit:risk profile. However, geriatric assessments are needed to improve selection of elderly patients potentially gaining symptom and quality of life improvements from bevacizumab-containing therapy. Clinical trials registration ClinicalTrials.gov NCT00976911.

Original languageEnglish
Pages (from-to)65-71
Number of pages7
JournalGynecologic Oncology
Volume144
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

    Fingerprint

Keywords

  • Bevacizumab
  • Elderly
  • Ovarian cancer
  • Patient-reported outcomes
  • Platinum resistant

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

Cite this

Sorio, R., Roemer-Becuwe, C., Hilpert, F., Gibbs, E., García, Y., Kaern, J., Huizing, M., Witteveen, P., Zagouri, F., Coeffic, D., Lück, H. J., González-Martín, A., Kristensen, G., Levaché, C. B., Lee, C. K., Gebski, V., & Pujade-Lauraine, E. (2017). Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial. Gynecologic Oncology, 144(1), 65-71. https://doi.org/10.1016/j.ygyno.2016.11.006