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Bending the Curve Trial by Trial
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LION

A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

N = 647NCT00712218

Population
Newly diagnosed advanced ovarian cancer (FIGO IIB to IV) with macroscopically complete resection and normal lymph nodes before and during surgery
Design
Intraoperative randomisation of patients with newly diagnosed FIGO stage IIB to IV ovarian cancer who had macroscopically complete resection and normal lymph nodes both before and during surgery, to systematic pelvic and paraaortic lymphadenectomy or no lymphadenectomy. Centres had to qualify with regard to surgical skills. The primary end point was overall survival.
Primary endpoint
OS
Arms
  • Lymphadenectomy (control, n = 323): Systematic pelvic and paraaortic lymphadenectomy
  • No lymphadenectomy (experimental, n = 324): No lymphadenectomy
People
Harter P
OSHR 1.06 (95% CI 0.83–1.34)Δ median OS+3.7 monthsPFSHR 1.11 (95% CI 0.92–1.34)Δ median PFS0 monthsΔ Repeat laparotomy−5.9 pointsΔ Mortality within 60 days of surgery−2.2 points
Show the numbers
Results reported for LION
EndpointAnalysisNo lymphadenectomyLymphadenectomyEffect
OSAll randomised patients, as analysed in the report (647); not labelled intention-to-treat in the abstractprimaryHarter 2019median 69.2 monthsmedian 65.5 monthsHR 1.06 (95% CI 0.83–1.34)P=0.65Hazard ratio for death in the lymphadenectomy group compared with the no-lymphadenectomy group.
PFSAll randomised patients, as analysed in the report (647); not labelled intention-to-treat in the abstractprimaryHarter 2019median 25.5 monthsmedian 25.5 monthsHR 1.11 (95% CI 0.92–1.34)P=0.29Hazard ratio for progression or death in the lymphadenectomy group. Overall survival, not progression-free survival, was the primary end point.
Repeat laparotomyAll randomised patients, as analysed in the report (647)primaryHarter 20196.5%12.4%P=0.01
Mortality within 60 days of surgeryAll randomised patients, as analysed in the report (647)primaryHarter 20190.9%3.1%P=0.049
Results reported for LION
EndpointAnalysisNo lymphadenectomyLymphadenectomyEffect
OSAll randomised patients, as analysed in the report (647); not labelled intention-to-treat in the abstractprimaryHarter 2019median 69.2 monthsmedian 65.5 monthsHR 1.06 (95% CI 0.83–1.34)P=0.65Hazard ratio for death in the lymphadenectomy group compared with the no-lymphadenectomy group.
PFSAll randomised patients, as analysed in the report (647); not labelled intention-to-treat in the abstractprimaryHarter 2019median 25.5 monthsmedian 25.5 monthsHR 1.11 (95% CI 0.92–1.34)P=0.29Hazard ratio for progression or death in the lymphadenectomy group. Overall survival, not progression-free survival, was the primary end point.
Repeat laparotomyAll randomised patients, as analysed in the report (647)primaryHarter 20196.5%12.4%P=0.01
Mortality within 60 days of surgeryAll randomised patients, as analysed in the report (647)primaryHarter 20190.9%3.1%P=0.049
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.060.83–1.34
PFS1.110.92–1.34
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%050100150Months (modelled)
  • Lymphadenectomy (control)
  • No lymphadenectomy (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLymphadenectomyNo lymphadenectomy
0100.0%100.0%
4363.4%65.0%
8739.8%41.8%
13025.3%27.2%
17316.0%17.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Lymphadenectomy (control)
  • No lymphadenectomy (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLymphadenectomyNo lymphadenectomy
0100.0%100.0%
1664.7%64.7%
3241.9%41.9%
4827.1%27.1%
6417.6%17.6%
Primary publication: Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, et al. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019;380(9):822-832. PubMedDOI

Appears in

Sources

  1. Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, et al. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019;380(9):822-832.

    PubMedDOI