A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms
- Study type
- Clinical trial
- Study name
- LION (AGO-OVAR OP.3)
- Phase
- Phase 3
- Design
- Randomised intraoperative trial at centres with certified surgical expertise
- Sample size
- 647 patients
- Source
- N Engl J Med · 2019
- Trial registration
- NCT00712218
In plain words
In surgery for advanced ovarian cancer, if the lymph nodes look normal on scans and during the operation, removing all of them does not help the patient live longer and only adds to the complications of surgery. This study led to shorter and safer operations.
Key results
Treatment arms and regimens
Systematic removal of pelvic and para-aortic lymph nodes (median 57 nodes: 35 pelvic and 22 para-aortic). This is a surgical intervention with no drug dose.
Normal-appearing lymph nodes were not removed.
Source of the regimen details: Surgical intervention; no drug dose
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with newly diagnosed advanced ovarian cancer (FIGO stage IIB to IV) who had complete macroscopic intra-abdominal resection and whose lymph nodes were normal before and during surgery.
Endpoints
Primary endpoint: overall survival. Secondary: progression-free survival and postoperative complications.
Safety and side effects
Serious postoperative complications were more frequent in the lymphadenectomy group, including repeat laparotomy (12.4% versus 6.5%; P=0.01) and death within 60 days of surgery (3.1% versus 0.9%; P=0.049).
Clinical significance and place in guidelines
LION removed systematic lymphadenectomy from the surgical standard for advanced ovarian cancer in patients with complete resection and clinically normal nodes. The main goal of surgery remains complete removal of all visible disease (ESMO Pan-Asian 2025: [III, A]).
Limitations
Conducted only at centres with high surgical quality; the results cannot be applied to patients with enlarged or suspicious nodes or incomplete resection; conducted before the era of PARP inhibitor maintenance.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.