A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

TY - JOUR

T1 - A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

AU - Harter, Philipp

AU - Sehouli, Jalid

AU - Lorusso, Domenica

AU - Reuss, Alexander

AU - Vergote, Ignace

AU - Marth, Christian

AU - Kim, Jae-Weon

AU - Raspagliesi, Francesco

AU - Lampe, Björn

AU - Aletti, Giovanni

AU - Meier, Werner

AU - Cibula, David

AU - Mustea, Alexander

AU - Mahner, Sven

AU - Runnebaum, Ingo B

AU - Schmalfeldt, Barbara

AU - Burges, Alexander

AU - Kimmig, Rainer

AU - Scambia, Giovanni

AU - Greggi, Stefano

AU - Hilpert, Felix

AU - Hasenburg, Annette

AU - Hillemanns, Peter

AU - Giorda, Giorgio

AU - von Leffern, Ingo

AU - Schade-Brittinger, Carmen

AU - Wagner, Uwe

AU - du Bois, Andreas

N1 - Copyright © 2019 Massachusetts Medical Society.

PY - 2019/2/28

Y1 - 2019/2/28

N2 - 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.).

AB - 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.).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - CA-125 Antigen/blood

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Lymph Node Excision/adverse effects

KW - Lymphatic Metastasis

KW - Middle Aged

KW - Operative Time

KW - Ovarian Neoplasms/pathology

KW - Postoperative Complications

KW - Progression-Free Survival

KW - Proportional Hazards Models

KW - Survival Rate

KW - Treatment Failure

KW - Young Adult

U2 - 10.1056/NEJMoa1808424

DO - 10.1056/NEJMoa1808424

M3 - SCORING: Journal article

C2 - 30811909

VL - 380

SP - 822

EP - 832

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 9

ER -