Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged & GE;65 years from the PAOLA-1/ENGOT-ov25 trial

Background: The phase III PAOLA-1/ENGOT-ov25 study (NCT02477644) showed that addition of olaparib to bevacizumab maintenance improved progression-free sur-vival (PFS) in patients with newly diagnosed advanced ovarian cancer. We evaluated mainte-nance olaparib plus bevacizumab in older patients in PAOLA-1.Methods: Baseline clinical and molecular data, and PFS, were compared between older (aged >65 years) and younger patients (<65 years). Factors associated with olaparib efficacy, and safety in age subgroups, were also assessed.Results: Of 806 randomised patients, 292 (36.2%) were >65 years. A lower proportion of older versus younger patients had an Eastern Cooperative Oncology Group performance status of 0 (61.0% versus 76.2%) and upfront surgery (42.0% versus 55.7%). Older patients were less likely to have a BRCA1/2 mutation (17.1% versus 36.7%) or homologous recombination defi-ciency-positive status (34.1% versus 55.7%). After median follow-up of 22.1 months, median PFS was 21.6 months with olaparib versus 16.6 months with placebo in the older population (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.41-0.75 ), comparable with the younger population (median 22.9 versus 16.9 months; HR 0.61, 95% CI 0.49-0.77). PFS ben-efits were observed in patients with a BRCA mutation or homologous recombination defi-ciency-positive tumours. Incidence of olaparib-related grade >3 adverse events in older patients was comparable with that of younger patients (36.8% versus 31.7%) although hyper-tension and anaemia were more common in older patients. No treatment-related deaths occurred in older patients receiving olaparib.Conclusion: Older patients enrolled in PAOLA-1 achieved similar PFS benefits compared with younger patients, with a similar safety profile. 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

In the PAOLA-1 study, maintenance olaparib plus bevacizumab was found to improve progression-free survival in older patients with advanced ovarian cancer, with similar efficacy and safety to younger patients.