The Absolute Effect / Oncology Evidence / Evidence Index
ATHENA-MONO
After response to first-line platinum chemotherapy for advanced ovarian cancer, does rucaparib maintenance improve PFS over placebo in an unselected population?
Registry: NCT03522246 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III double-blind randomized 4:1; n=538.Primary-source evidence summaryStudy design, population and eligibility
Phase III double-blind randomized 4:1; n=538.
Stage III–IV high-grade ovarian/fallopian tube/primary peritoneal cancer after response to first-line platinum doublet.
Treatment and comparator
Intervention: Rucaparib 600 mg twice daily up to 24 months.
Comparator: Placebo.
Endpoints
Investigator-assessed PFS hierarchical HRD then ITT.
Key efficacy and clinical outcomes
ITT median PFS 20.2 vs 9.2 mo (HR .52); HRD 28.7 vs 11.3 mo (HR .47). Later OS immature (HR .83; 95% CI .58–1.17).
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. First-line maintenance after response to platinum chemotherapy
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Grade ≥3 anaemia 28.7% vs 0%; neutropenia 14.6% vs 0.9%; monitor CBC and rare MDS/AML.
Absolute effect and NNT/NNH
PFS benefit established; OS immature; PARPi indications/sequencing have evolved, so current guideline/regulatory review is needed.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
PFS benefit established; OS immature; PARPi indications/sequencing have evolved, so current guideline/regulatory review is needed.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.