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Randomized Controlled Trial
. 2019 Feb 28;380(9):822-832.
doi: 10.1056/NEJMoa1808424.

A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

Philipp Harter  1 , Jalid Sehouli  1 , Domenica Lorusso  1 , Alexander Reuss  1 , Ignace Vergote  1 , Christian Marth  1 , Jae-Weon Kim  1 , Francesco Raspagliesi  1 , Björn Lampe  1 , Giovanni Aletti  1 , Werner Meier  1 , David Cibula  1 , Alexander Mustea  1 , Sven Mahner  1 , Ingo B Runnebaum  1 , Barbara Schmalfeldt  1 , Alexander Burges  1 , Rainer Kimmig  1 , Giovanni Scambia  1 , Stefano Greggi  1 , Felix Hilpert  1 , Annette Hasenburg  1 , Peter Hillemanns  1 , Giorgio Giorda  1 , Ingo von Leffern  1 , Carmen Schade-Brittinger  1 , Uwe Wagner  1 , Andreas du Bois  1
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Free article
Randomized Controlled Trial

A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

Philipp Harter et al. N Engl J Med. .
Free article

Abstract

Background: Systematic pelvic and paraaortic 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 resection 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 participation in the trial. The primary end point was overall survival.

Results: A total of 647 patients underwent randomization from December 2008 through January 2012, were assigned to undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included in the analysis. Among patients who underwent 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 lymphadenectomy 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 postoperative 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 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. (Funded by Deutsche Forschungsgemeinschaft and the Austrian Science Fund; LION ClinicalTrials.gov number, NCT00712218.).

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Comment in

  • Ovarian Cancer Surgery - Heed This LION's Roar.
    Eisenhauer EL, Chi DS. Eisenhauer EL, et al. N Engl J Med. 2019 Feb 28;380(9):871-873. doi: 10.1056/NEJMe1900044. N Engl J Med. 2019. PMID: 30811915 No abstract available.
  • Lymphadenectomy is not always required.
    Sidaway P. Sidaway P. Nat Rev Clin Oncol. 2019 Jun;16(6):337. doi: 10.1038/s41571-019-0200-x. Nat Rev Clin Oncol. 2019. PMID: 30867574 No abstract available.
  • Lymph removal not tied to positive outcomes.
    Stower H. Stower H. Nat Med. 2019 Apr;25(4):541. doi: 10.1038/s41591-019-0426-2. Nat Med. 2019. PMID: 30948850 No abstract available.
  • Lymphadenectomy in Advanced Ovarian Neoplasms.
    Morice P, Pautier P, Gouy S. Morice P, et al. N Engl J Med. 2019 Jun 6;380(23):2274. doi: 10.1056/NEJMc1904411. N Engl J Med. 2019. PMID: 31167062 No abstract available.
  • Excerpts from the World Medical Literature.
    Ziegler C. Ziegler C. J Obstet Gynaecol Can. 2019 Aug;41(8):1077-1079. doi: 10.1016/j.jogc.2019.05.003. J Obstet Gynaecol Can. 2019. PMID: 31331606 No abstract available.
  • A lion with only two legs.
    Ouldamer L, Caille A, Giraudeau B. Ouldamer L, et al. J Gynecol Obstet Hum Reprod. 2020 Mar;49(3):101686. doi: 10.1016/j.jogoh.2020.101686. Epub 2020 Jan 10. J Gynecol Obstet Hum Reprod. 2020. PMID: 31931146 No abstract available.

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