A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms

Philipp Harter, Jalid Sehouli, Domenica Lorusso, Alexander Reuss, Ignace Vergote, Christian Marth, Jae Weon Kim, Fran Cesco Raspagliesi, Björn Lampe, Giovanni Aletti, Werner Meier, David Cibula, Alexander Mustea, Sven Mahner, Ingo B. Runnebaum, Barbara Schmalfeldt, Alexander Burges, Rainer Kimmig, Giovanni Scambia, Stefano GreggiFelix Hilpert, Annette Hasenburg, Peter Hillemanns, Giorgio Giorda, Ingo Von Leffern, Carmen Schade-Brittinger, Uwe Wagner, Andreas Du Bois

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)822-832
Number of pages11
JournalNew England Journal of Medicine
Volume380
Issue number9
DOIs
StatePublished - 28 Feb 2019

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Lymph Node Excision
Ovarian Neoplasms
Disease-Free Survival
Lymph Nodes
Confidence Intervals
Survival
Incidence
Random Allocation
Gynecology
Ambulatory Surgical Procedures
Laparotomy
Obstetrics
Randomized Controlled Trials

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Harter, P., Sehouli, J., Lorusso, D., Reuss, A., Vergote, I., Marth, C., ... Du Bois, A. (2019). A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms. New England Journal of Medicine, 380(9), 822-832. https://doi.org/10.1056/NEJMoa1808424
Harter, Philipp ; Sehouli, Jalid ; Lorusso, Domenica ; Reuss, Alexander ; Vergote, Ignace ; Marth, Christian ; Kim, Jae Weon ; Raspagliesi, Fran Cesco ; Lampe, Björn ; Aletti, Giovanni ; Meier, Werner ; Cibula, David ; Mustea, Alexander ; Mahner, Sven ; Runnebaum, Ingo B. ; Schmalfeldt, Barbara ; Burges, Alexander ; Kimmig, Rainer ; Scambia, Giovanni ; Greggi, Stefano ; Hilpert, Felix ; Hasenburg, Annette ; Hillemanns, Peter ; Giorda, Giorgio ; Von Leffern, Ingo ; Schade-Brittinger, Carmen ; Wagner, Uwe ; Du Bois, Andreas. / A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms. In: New England Journal of Medicine. 2019 ; Vol. 380, No. 9. pp. 822-832.
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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.",
author = "Philipp Harter and Jalid Sehouli and Domenica Lorusso and Alexander Reuss and Ignace Vergote and Christian Marth and Kim, {Jae Weon} and Raspagliesi, {Fran Cesco} and Bj{\"o}rn Lampe and Giovanni Aletti and Werner Meier and David Cibula and Alexander Mustea and Sven Mahner and Runnebaum, {Ingo B.} and Barbara Schmalfeldt and Alexander Burges and Rainer Kimmig and Giovanni Scambia and Stefano Greggi and Felix Hilpert and Annette Hasenburg and Peter Hillemanns and Giorgio Giorda and {Von Leffern}, Ingo and Carmen Schade-Brittinger and Uwe Wagner and {Du Bois}, Andreas",
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Harter, P, Sehouli, J, Lorusso, D, Reuss, A, Vergote, I, Marth, C, Kim, JW, Raspagliesi, FC, Lampe, B, Aletti, G, Meier, W, Cibula, D, Mustea, A, Mahner, S, Runnebaum, IB, Schmalfeldt, B, Burges, A, Kimmig, R, Scambia, G, Greggi, S, Hilpert, F, Hasenburg, A, Hillemanns, P, Giorda, G, Von Leffern, I, Schade-Brittinger, C, Wagner, U & Du Bois, A 2019, 'A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms', New England Journal of Medicine, vol. 380, no. 9, pp. 822-832. https://doi.org/10.1056/NEJMoa1808424

A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms. / Harter, Philipp; Sehouli, Jalid; Lorusso, Domenica; Reuss, Alexander; Vergote, Ignace; Marth, Christian; Kim, Jae Weon; Raspagliesi, Fran Cesco; Lampe, Björn; Aletti, Giovanni; Meier, Werner; Cibula, David; Mustea, Alexander; Mahner, Sven; Runnebaum, Ingo B.; Schmalfeldt, Barbara; Burges, Alexander; Kimmig, Rainer; Scambia, Giovanni; Greggi, Stefano; Hilpert, Felix; Hasenburg, Annette; Hillemanns, Peter; Giorda, Giorgio; Von Leffern, Ingo; Schade-Brittinger, Carmen; Wagner, Uwe; Du Bois, Andreas.

In: New England Journal of Medicine, Vol. 380, No. 9, 28.02.2019, p. 822-832.

Research output: Contribution to journalArticle

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, Fran Cesco

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

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.

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.

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U2 - 10.1056/NEJMoa1808424

DO - 10.1056/NEJMoa1808424

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AN - SCOPUS:85062299661

VL - 380

SP - 822

EP - 832

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

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