PAOLA-1 / ENGOT-ov25
Does adding olaparib to bevacizumab maintenance improve outcomes, especially in HRD-positive ovarian cancer?
Trial design and population
Population: 806 patients responding to first-line platinum-taxane chemotherapy plus bevacizumab.
Treatment vs comparator: Olaparib 300 mg twice daily for up to 24 months plus bevacizumab 15 mg/kg every 3 weeks vs placebo plus bevacizumab.
Registry: NCT02477644
Key results
Overall ITT median OS 56.5 vs 51.6 months (HR 0.92, 95% CI 0.76–1.12; p=0.4118). HRD-positive: 5-year OS 65.5% vs 48.4% (HR 0.62, 95% CI 0.45–0.85); 5-year PFS 46.1% vs 19.2% (HR 0.41, 95% CI 0.32–0.54).
Five-year PFS, HRD-positive · 5 years
Bars are scaled to the larger reported value. Median survival differences are not NNTs.
Absolute effect
Endpoint/time horizon: Five-year PFS, HRD-positive · 5 years. NNT is not calculated from median survival or hazard ratios; use fixed-time absolute risks only. NNH not calculated without a defensible fixed-time excess-harm risk difference.
Safety, treatment burden and QoL
Anaemia, fatigue and nausea combine with bevacizumab-associated hypertension, proteinuria and vascular risks. Review full safety tables for grade-specific harms and discontinuation.
Quality-of-life and discontinuation percentages are not asserted without full source-table verification; source-level QoL/toxicity audit remains a QC item.
Subgroups, maturity and limitations
Overall ITT OS was not statistically significant; the HRD-positive benefit must not be generalized to HRD-negative/unknown tumours.
Distinguish prespecified from exploratory subgroup analyses and mature from immature endpoints. Verify current guideline context before applying historical trial findings.
Current-practice context · 21 October 2026
Confirm current guidelines, regulatory status, biomarkers, prior treatment, comorbidities and patient goals. Full clinical freshness and source-level QoL audit remain pending.