LION
After complete macroscopic resection of advanced ovarian cancer with clinically normal nodes, does systematic lymphadenectomy improve survival?
Trial design and population
Population: 647 patients with FIGO stage IIB–IV disease, complete macroscopic resection and normal nodes.
Treatment vs comparator: Systematic pelvic and para-aortic lymphadenectomy vs no systematic lymphadenectomy.
Registry: NCT00712218
Key results
Median OS 65.5 months with lymphadenectomy vs 69.2 months without (HR 1.06, 95% CI 0.83–1.34; p=0.65). Median PFS 25.5 months in both groups (HR 1.11, 95% CI 0.92–1.34; p=0.29).
Median overall survival · Primary analysis
Bars are scaled to the larger reported value. Median survival differences are not NNTs.
Absolute effect
Endpoint/time horizon: Median overall survival · Primary analysis. 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
Repeat laparotomy 12.4% vs 6.5%; 60-day postoperative mortality 3.1% vs 0.9%. Added operative burden, lymphocele and lymphoedema are relevant.
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
Applies to clinically normal nodes after complete macroscopic resection; not grossly suspicious/bulky nodes. No survival gain offset added morbidity in this population.
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.