SOLO-1 / GOG 3004
After response to platinum chemotherapy, does olaparib maintenance improve outcomes in advanced BRCA-mutated ovarian cancer?
Trial design and population
Registry: undefined.
Key results
Five-year PFS 48% vs 21% (HR 0.33, 95% CI 0.25–0.43). Seven-year OS 67.0% vs 46.5% (HR 0.55, 95% CI 0.40–0.76); p=0.0004 did not cross prespecified p<0.0001 boundary.
Outcome visualization
Five-year progression-free survival · 5 years · 48
Bars scale to the larger reported value. Median survival values are time-to-event summaries, not fixed-time absolute event risks.
Absolute Effect
Endpoint/time horizon: Five-year progression-free survival · 5 years · 48.
NNT: Not calculated from median survival or hazard ratios; calculate only from defensible fixed-time absolute risks.
NNH: Not calculated unless a fixed-time excess-harm risk difference is available. Applies to BRCA-mutated disease after platinum response. Seven-year OS estimate was favourable but did not meet the prespecified significance threshold.
Safety, burden and QoL
Applies to BRCA-mutated disease after platinum response. Seven-year OS estimate was favourable but did not meet the prespecified significance threshold.
QoL and discontinuation percentages are not asserted where not verified from the full primary report; complete source-table audit remains a QC item.
Subgroups, maturity and limitations
https://pubmed.ncbi.nlm.nih.gov/36082969/
Distinguish prespecified from exploratory subgroups, immature from mature endpoints, and superiority from non-inferiority. Historical comparators may not represent all current treatment sequences.
Current-practice context · 21 October 2026
Verify current guidelines, regulatory status, biomarker requirements, prior treatment, comorbidities and patient goals before applying these historical trial results. Clinical freshness and full QoL/toxicity source review remain open where noted.