Introduction/Background*The Phase III PAOLA-1/ENGOT-ov25 study (NCT02477644) demonstrated that the addition of olaparib to bevacizumab maintenance following standard platinum-based therapy plus bevacizumab improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer (Ray-Coquard et al. NEJM 2019). We aimed to describe safety, quality of life (QoL), and efficacy with olaparib plus bevacizumab in patients ≥70 years old.
Methodology Safety (adverse events [AEs] graded according to CTCAE v5.0) and QoL (measured using EORTC QLQ-C30 global health status [GHS]) data were collected. We compared safety by age (older [≥70 years] and younger patients [<70 years]) in the olaparib arm. Geriatric features, including Geriatric Vulnerability Score (GVS; Falandry et al. Ann Oncol 2013) items, and QoL by treatment arm were assessed in older patients.
Result(s)*Of 806 patients enrolled, 142 (17.6%) were ≥70 years old; 104 of these were in the olaparib arm. There was no notable difference in baseline characteristics between olaparib and placebo arms (table 1). In evaluation of safety, moderately increased rates of grade ≥3 treatment-related AEs (TRAEs), dose reductions and interruptions, and treatment discontinuation due to TRAEs were reported in older than younger patients (table 2). Grade 3–4 any-cause anaemia (21.2% vs 16.5%) and neutropenia (9.7% vs 5.1%) were more frequent in older patients. The most common grade 3–4 non-haematological AE was hypertension (26.9% vs 16.7%). No acute myeloid leukaemia, myelodysplastic syndrome, or treatment-related death was reported among older patients. Interestingly, GHS during the first 2 years of maintenance was similar between arms. Median PFS was 21.1 months with olaparib vs 14.3 months with placebo. Analyses by GVS and homologous recombination deficiency subgroups are ongoing and will be presented.
Conclusion*Among older patients in PAOLA-1, olaparib plus bevacizumab maintenance had a manageable safety profile and had no adverse impact on GHS. Median PFS in older patients was similar to the overall population. Analyses stratified by GVS will provide further insight into the safety profile of maintenance olaparib plus bevacizumab in older patients.
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