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

- The PFS and response rate benefit from bevacizumab were similar regardless of age.
- Grade ≥ 3 hypertension was more common with bevacizumab in older vs younger patients.
- Thromboembolic events were not increased with bevacizumab in patients ≥ 65 vs < 65 years.
- In older patients, no PRO benefit was seen with bevacizumab versus chemotherapy alone.

BackgroundThe AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC).MethodsPatients 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.ResultsIn 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.ConclusionIn 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 registrationClinicalTrials.gov NCT00976911.