@article{5cd8bf92fad543fb8bee55a5cfae1d8d,
title = "A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms: New England Journal of Medicine",
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. Copyright {\textcopyright} 2019 Massachusetts Medical Society.",
keywords = "adult, aged, Article, cancer staging, cancer survival, clinical effectiveness, controlled study, female, hazard ratio, human, laparotomy, lymph node dissection, lymph node metastasis, major clinical study, mortality, ovary cancer, overall survival, peroperative care, postoperative complication, priority journal, progression free survival, quality of life, randomized controlled trial, repeat procedure, survival time, blood, clinical trial, Kaplan Meier method, middle aged, multicenter study, operation duration, ovary tumor, pathology, proportional hazards model, survival rate, treatment failure, very elderly, young adult, CA 125 antigen, Adult, Aged, Aged, 80 and over, CA-125 Antigen, Female, Humans, Kaplan-Meier Estimate, Lymph Node Excision, Lymphatic Metastasis, Middle Aged, Operative Time, Ovarian Neoplasms, Postoperative Complications, Progression-Free Survival, Proportional Hazards Models, Survival Rate, Treatment Failure, Young Adult",
author = "P. Harter and J. Sehouli and D. Lorusso and A. Reuss and I. Vergote and C. Marth and J.-W. Kim and F.-C. Raspagliesi and B. Lampe and G. Aletti and W. Meier and D. Cibula and A. Mustea and S. Mahner and I.B. Runnebaum and B. Schmalfeldt and A. Burges and R. Kimmig and G. Scambia and S. Greggi and F. Hilpert and A. Hasenburg and P. Hillemanns and G. Giorda and {Von Leffern}, I. and C. Schade-Brittinger and U. Wagner and {Du Bois}, A.",
note = "Cited By :34 Export Date: 27 February 2020 CODEN: NEJMA Correspondence Address: Harter, P.; Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Evang. Huyssens-Stiftung Knappschaft, Henricistr. 92, Germany; email: p.harter@gmx.de Chemicals/CAS: CA-125 Antigen Funding details: Austrian Science Fund, FWF, KLI 176-B00 Funding details: Deutsche Forschungsgemeinschaft, DFG, WA 740/4 Funding details: AstraZeneca Funding details: Teva Pharmaceutical Industries Funding details: Clovis Oncology Funding details: Medtronic Funding details: Pfizer Funding details: GlaxoSmithKline, GSK Funding details: Meso Scale Diagnostics, MSD Funding details: Roche Funding text 1: Supported by the Deutsche Forschungsgemeinschaft (project WA 740/4) and the Austrian Science Fund (project KLI 176-B00). Funding text 2: Dr. Harter reports receiving lecture fees, advisory board fees, and travel support from AstraZeneca and Roche, lecture fees and advisory board fees from Tesaro and PharmaMar, advisory board fees from Clovis, Lilly, and Immunogen, travel support from Medac, and lecture fees from Stryker; Dr. Lorusso, receiving grant support and consulting fees from PharmaMar, grant support and advisory board fees from Clovis and Merck, advisory board fees from AstraZeneca and Tesaro, and consulting fees from Roche; Dr. Mahner, receiving grant support, lecture fees, advisory board fees, and travel support from AstraZeneca, Roche, and Tesaro, advisory board fees and travel support from Clovis, grant support, lecture fees, and travel support from GlaxoSmithKline, Medac, PharmaMar, and Teva, grant support, advisory board fees, and travel support from MSD and Sensor Kinesis; Dr. Kimmig, receiving lecture fees from AstraZeneca, Prostrakan, and Riemser, fees for proctoring and lecture fees from Intuitive Surgical, advisory board fees from Medtronic, fees for serving at an expert meeting from Teva, and travel support from Cambridge Medical Robotics; Dr. Hasenburg, receiving advisory board fees from Theraclion and Tesaro, advisory board fees and honoraria from PharmaMar and Roche Pharma, honoraria from Medconcept, Celgene, GlaxoSmithKline, Teva, MedUpdate, Pfizer, AstraZeneca, and Pierre Fabre; Dr. du Bois, receiving advisory board fees from AstraZeneca, Roche, Tesaro, Clovis, BioCad, Genmab, and Pfizer. No other potential conflict of interest relevant to this article was reported. 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year = "2019",
doi = "10.1056/NEJMoa1808424",
language = "English",
volume = "380",
pages = "822--832",
journal = "New Engl. J. Med.",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "9",
}