Pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and normal lymph nodes before and during surgery did not result in improved survival outcomes, according to a randomized trial. Unsurprisingly, lymphadenectomy was associated with increased incidence of postoperative complications.
“Some retrospective analyses have suggested a potential survival benefit from systematic pelvic and para-aortic lymphadenectomy in patients with macroscopically completely resected advanced ovarian cancer,” wrote study authors led by Philipp Harter, MD, PhD, of the Kliniken Essen-Mitte in Germany. One prospective trial found no benefit, but there were questions regarding its methodology and patient selection.
The new LION trial included patients with newly diagnosed advanced ovarian cancer who had undergone macroscopically complete resection; all patients had normal lymph nodes before and during surgery, and they were randomized to either undergo (323 patients) or not undergo (324 patients) systematic lymphadenectomy. The results were published in the New England Journal of Medicine.
The assigned intervention was performed in 99.1% of those randomized to undergo lymphadenectomy, and in 96.6% of those randomized to not undergo the procedure. In those undergoing lymphadenectomy, a median of 57 resected lymph nodes were reported; 55.7% of those patients had microscopic lymph node metastases.
The median overall survival was 65.5 months in the lymphadenectomy group, and 69.2 months in the no-lymphadenectomy group, for a hazard ratio of 1.06 (95% CI, 0.83–1.34; P = .65). There was similarly no difference with regard to progression-free survival, with a median of 25.5 months in both groups and an HR of 1.11 (95% CI, 0.92–1.34; P = .29).
A quality-of-life analysis found no significant differences between the groups. Adding lymphadenectomy increased surgical time (340 minutes vs 280 minutes; P < .001), and it increased median blood loss (650 mL vs 500 mL; P < .001) and the percentage of patients receiving transfusions (63.7% vs 56.0%; P = .005). More patients undergoing lymphadenectomy had a postoperative admission to an intermediate or intensive care unit (77.6% vs 69.0%; P = .01), and the lymphadenectomy group had a higher incidence of infections treated with antibiotics (25.8% vs 18.6%; P = .03). They also had a higher risk of undergoing repeat laparotomy for complications (12.4% vs 6.5%; P = .01).
In an accompanying editorial, Eric L. Eisenhauer, MD, of Massachusetts General Hospital in Boston, and Dennis S. Chi, MD, of Memorial Sloan Kettering Cancer Center in New York, praised the trial’s design for its ability to address some of the shortcomings of previous research on this topic.
“Women with ovarian cancer in whom complete primary cytoreduction is achieved have the best prognosis and longest survival,” they wrote. “The procedures required to achieve complete cytoreduction already have attendant risks, and eliminating ineffective techniques such as systematic lymphadenectomy is prudent to improve patients’ overall recovery.”