Philipp Harter1, Jalid Sehouli1, Domenica Lorusso1, Alexander Reuss1, Ignace Vergote1, Christian Marth1, Jae-Weon Kim1, Francesco Raspagliesi1, Björn Lampe1, Giovanni Aletti1, Werner Meier1, David Cibula1, Alexander Mustea1, Sven Mahner1, Ingo B Runnebaum1, Barbara Schmalfeldt1, Alexander Burges1, Rainer Kimmig1, Giovanni Scambia1, Stefano Greggi1, Felix Hilpert1, Annette Hasenburg1, Peter Hillemanns1, Giorgio Giorda1, Ingo von Leffern1, Carmen Schade-Brittinger1, Uwe Wagner1, Andreas du Bois1. 1. From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).
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.).
RCT Entities:
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.).
Authors: Roberto C Delgado Bolton; Nicolas Aide; Patrick M Colletti; Annamaria Ferrero; Diana Paez; Andrea Skanjeti; Francesco Giammarile Journal: Eur J Nucl Med Mol Imaging Date: 2021-07-03 Impact factor: 9.236