Introduction/Background*The Phase IIIb single-arm OPINION study was the first study to prospectively evaluate maintenance olaparib in patients with non-germline BRCA1 and/or BRCA2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC). Median progression-free survival (PFS) in OPINION was 9.2 months (95% confidence interval [CI] 7.6–10.9) (Poveda et al. ASCO 2021), showing clinical benefit vs historical controls. Limited data are available focussing on older patients with OC receiving olaparib. We evaluated the efficacy and safety of maintenance olaparib in OPINION patients aged <70 and ≥70 years.
Methodology Patients with high-grade serous or endometrioid non-gBRCAm OC who had received ≥2 prior lines of platinum-based chemotherapy and were in response to their most recent platinum regimen received olaparib tablets (300 mg bid) until disease progression or unacceptable toxicity. This post hoc subgroup analysis evaluated investigator-assessed PFS (modified RECIST v1.1; primary endpoint), time to first subsequent therapy or death (TFST) and safety in patients aged <70 and ≥70 years.
Result(s)*At enrolment, median patient age was 65.0 years (range 40–85); 192 patients were aged <70 years (median 60.0 years; range 40–69) and 87 were aged ≥70 years (median 74.0 years; range 70–85). Among patients aged <70 vs ≥70 years, 73% vs 59% were Eastern Cooperative Oncology Group (ECOG) performance status 0, 27% vs 41% were ECOG performance status 1, 64% vs 49% had received only two prior platinum regimens, 36% vs 51% had received ≥3 prior platinum regimens, and 35% vs 28% had a complete response and 64% vs 70% had a partial response to their latest platinum regimen. At data cut-off (2 Oct 2020), median PFS and 18-month PFS rates were similar in both age groups (figure 1). Median TFST was 15.6 months (95% CI 12.2–18.1) in patients aged <70 years and 11.4 months (95% CI 9.7–15.6) in patients ≥70 years. The safety profile of maintenance olaparib (median treatment duration 9 months) was generally similar in both age groups (table 1).
Conclusion*Efficacy and safety data support the use of maintenance olaparib in non-gBRCAm PSR OC patients irrespective of age.
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