PracticeUpdate Oncology May 2019

EDITOR’S PICKS 6

Lymphadenectomy in Patients With Advanced Ovarian Neoplasms The New England Journal of Medicine

COMMENT By Annette Hasenburg Prof., Dr, med U ntil recently, systemic pelvic and para-aortic lymphadenectomy had been the “gold standard” in the surgical management of patients with advanced ovarian cancer. The LION study now challenged this widely used surgical practice. Patients with ovarian cancer stage IIB through IV who had undergone mac- roscopically complete tumor debulking and had no evidence of overt lymph node involvement both before and during surgery were intraoperatively randomized to either systematic lym- phadenectomy or no lymphadenectomy. In the lymphadenectomy group, a median of 57 lymph nodes were resected (22 para-aortic and 35 pelvic nodes); of those, 55.7% revealed micro- scopic lymph node metastases. The median overall survival was 69.2 months in the no-lymphadenec- tomy group and 65.5 months in the lymphadenectomy group, a non- significant difference. The median progression-free survival reached 25.5 months in both groups. Serious postoperative complications occurred more frequently in the lymphadenec- tomy group, with a higher incidence of repeat laparotomy (12.4% vs 6.5%) and increased 60-day mortality after surgery (3.1% vs 0.9%). Overall, patients enrolled in the trial had a favorable outcome, with a median overall survival of more than 5 years, which could at least in part be due to the fact that high surgical quality was assured in the participating centers. Patients with macroscopically complete resection of advanced ovarian cancer and clinically negative lymph nodes did not benefit from systematic lymphad- enectomy, which was associated with higher morbidity and mortality. There- fore, this approach should be omitted in patients meeting the inclusion criteria of the LION trial. This study is of practice-changing value.

Take-home message • Patients with newly diagnosed advanced ovarian cancer (FIGO stage IIB–IV) who underwent macroscopically complete resection and had normal lymph nodes before and during surgery were randomized to undergo (n=323) or not undergo (n=324) systematic pelvic and para-aortic lymphadenectomy. There was no differ- ence in the median overall and progression-free survival between the two groups. Significantly more serious postoperative complications occurred in the women who underwent lymphadenectomy compared with those who did not. • Systematic pelvic and para-aortic lymphadenectomy was not associated with a survival benefit among patients with advanced ovarian cancer and normal lymph nodes. Lymphadenectomy did, however, increase the risk of postoperative complications. Jeffrey M. Wiisanen MD

in the analysis. Among patients who under- went lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenec- tomy group (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval [CI], 0.83 to 1.34; P=0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P = 0.29). Serious postopera- tive complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P=0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P=0.049]). CONCLUSIONS Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdom- inal 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 lymphad- enectomy and was associated with a higher incidence of postoperative complications. A Randomized Trial of Lymphadenectomy in Patients With Advanced Ovarian Neoplasms. N Engl J Med 2019 Feb 28;380(9)822-832, P Harter, J Sehouli, D Lorusso, et al. www.practiceupdate.com/c/80429 clinically negative lymph nodes did not benefit from systematic lymphadenectomy, which was associated with higher morbidity and mortality. " " Patients with macroscopically complete resection of advanced ovarian cancer and

Abstract BACKGROUND Systematic pelvic and paraaor- tic lymphadenectomy has been widely used in the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical trials has been limited. METHODS We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resec- tion and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before par- ticipation in the trial. The primary end point was overall survival. RESULTS A total of 647 patients underwent ran- domization from December 2008 through January 2012, were assigned to undergo lym- phadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included

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