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A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms
P. Harter, J. Sehouli, D. Lorusso, A. Reuss, I. Vergote, C. Marth, JW. Kim, F. Raspagliesi, B. Lampe, G. Aletti, W. Meier, D. Cibula, A. Mustea, S. Mahner, IB. Runnebaum, B. Schmalfeldt, A. Burges, R. Kimmig, G. Scambia, S. Greggi, F. Hilpert, A....
Language English Country United States
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1980-01-03 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1980-01-03 to 3 months ago
Health & Medicine (ProQuest)
from 1980-01-03 to 3 months ago
Family Health Database (ProQuest)
from 1980-01-03 to 3 months ago
Psychology Database (ProQuest)
from 1980-01-03 to 3 months ago
Health Management Database (ProQuest)
from 1980-01-03 to 3 months ago
Public Health Database (ProQuest)
from 1980-01-03 to 3 months ago
PubMed
30811909
DOI
10.1056/nejmoa1808424
Knihovny.cz E-resources
- MeSH
- CA-125 Antigen blood MeSH
- Operative Time MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Kaplan-Meier Estimate MeSH
- Middle Aged MeSH
- Humans MeSH
- Lymph Node Excision * adverse effects MeSH
- Lymphatic Metastasis MeSH
- Survival Rate MeSH
- Young Adult MeSH
- Ovarian Neoplasms pathology surgery MeSH
- Treatment Failure MeSH
- Postoperative Complications MeSH
- Proportional Hazards Models MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.).
Cancer Reference Center Centro di Riferimento Oncologico Aviano Italy
Coordinating Center for Clinical Trials Philipps University Marburg
Department of Gynecologic Oncology European Institute of Oncology University of Milan
Department of Gynecology and Obstetrics Albertinen Krankenhaus
Department of Gynecology and Obstetrics Hannover Medical School Hannover
Department of Gynecology and Obstetrics Kaiserswerther Diakonie
Department of Gynecology and Obstetrics University Hospital Giessen and Marburg
Department of Gynecology and Obstetrics University Hospital Kiel Kiel
Department of Gynecology and Obstetrics University Medicine Greifswald Greifswald
Department of Gynecology Charité Universitätsmedizin Berlin Berlin
Department of Gynecology University Medical Center Hamburg Eppendorf
Department of Obstetrics and Gynecology Catholic University of the Sacred Heart Rome
Department of Obstetrics and Gynecology Heinrich Heine University Düsseldorf
Department of Obstetrics and Gynecology Medical University Innsbruck Innsbruck Austria
Department of Obstetrics and Gynecology University Hospital Ludwig Maximilians Universität München
Department of Obstetrics and Gynecology University Munich rechts der Isar
From the Department of Gynecology and Gynecologic Oncology Kliniken Essen Mitte Essen
References provided by Crossref.org
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- $a 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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