Philipp Harter, MD
In the international phase III LION study reported in The New England Journal of Medicine, Philipp Harter, MD, and colleagues found that lymphadenectomy did not improve progression-free or overall survival vs no lymphadenectomy in women with advanced ovarian cancer.
The trial enrolled 647 women with newly diagnosed International Federation of Gynecology and Obstetrics stage IIB through IV disease who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery. They were intraoperatively randomly assigned between December 2008 and January 2012 to undergo lymphadenectomy (n = 323) or no lymphadenectomy (n = 324). Patients were enrolled at 59 sites primarily in Austria, Germany, and Italy. Randomization was stratified by trial center, patient age, and Eastern Cooperative Group performance status (0 or 1). All study centers had to qualify with regard to surgical skills.
The primary endpoint was overall survival.
Overall and Progression-Free Survival
The median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes) among patients in the lymphadenectomy group. Median overall survival was 65.5 months in the lymphadenectomy group vs 69.2 months in no-lymphadenectomy group (hazard ratio [HR] = 1.06, P = .65). Median progression-free survival was 25 months in both groups.
Lymphadenectomy was associated with significant effects (all P < .05) on median duration of surgery (340 vs 280 minutes), median blood loss (650 vs 500 mL), percentage of patients receiving transfusions (63.7% vs 56.0%), and postoperative admission to an intermediate or intensive care unit (77.6% vs 69.0%). Serious postoperative complications occurred more frequently in the lymphadenectomy group, including repeat laparotomy (12.4% vs 6.5%, P = .01) and mortality within 60 days after surgery (3.1% vs 0.9%, P = .049).
The investigators concluded: “Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectomy and was associated with a higher incidence of postoperative complications.” ■