2017 ASCO Annual Meeting!
Session: Gynecologic Cancer
Type: Oral Abstract Session
Time: Friday June 2, 3:00 PM to 6:00 PM
LION: Lymphadenectomy in ovarian neoplasms—A prospective randomized AGO study group led gynecologic cancer intergroup trial.
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 5500)
Author(s): Philipp Harter, Jalid Sehouli, Domenica Lorusso, Alexander Reuss, Ignace Vergote, Christian Marth, Jae Weon Kim, Francesco Raspagliesi, Boern Lampe, Fabio Landoni, Werner Meier, David Cibula, Alexander Mustea, Sven Mahner, Ingo B. Runnebaum, Barbara Schmalfeldt, Alexander Burges, Rainer Kimmig, Uwe A. G. Wagner, Andreas Du Bois; AGO and Kliniken Essen Mitte, Essen, Germany; AGO and Charité Campus Virchow-Klinikum, Berlin, Germany; MITO and Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; AGO and Coordinating Center for Clinical Trials, Marburg, Germany; BGOG and University of Leuven, Leuven Cancer Institute, Leuven, Belgium; AGO-A and Department of Obstetrics and Gynecology, Innsbruck Medical University, Innsbruck, Austria; KGOG and Seoul National University, Seoul, Korea South; AGO and Kaiserswerther Diakonie, Duesseldorf, Germany; MaNGO and Division of Gynecologic Oncology, European Institute of Oncology, Milan, Italy; AGO and Frauenklinik, Evangelisches Krankenhaus Duesseldorf, Duesseldorf, Germany; AGO and Oncogynecological Centre, Department of Obstetrics and Gynecology, Charles University, Prague, Czech Republic; AGO and University Medicine Greifswald, Department of Gynaecology and Obstetrics, Greifswald, Germany; AGO and University of Munich, Munich, Germany; AGO and University Hospital Jena, Jena, Germany; AGO and Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; AGO and Department of Gynecology, University Hospital Munich-Großhadern, Munich, Germany; AGO and Department of Gynecology and Obstetrics, University of Duisburg-Essen, Essen, Germany; AGO and Philipps University Marburg, Marburg, Germany
Background: So far, there is no level-1 evidence regarding the role of systematic pelvic and para-aortic lymphadenectomy (LNE) in patients with advanced ovarian cancer (AOC) with macroscopic complete resection und clinically negative lymph nodes (LN). Therefore, surgical management regarding LNE worldwide is very heterogeneous. Methods: Prospective randomized trial including patients with newly diagnosed AOC FIGO IIB-IV with macroscopic complete resection and pre- and intra-operatively clinical negative LN were randomized intra-operatively to LNE versus no-LNE. All centers had to qualify regarding surgical skills before participation in this trial. The primary endpoint was overall survival. Results: 647 patients were randomized between 12/08 and 1/12 to LNE (n=323) or no-LNE (n=324). The median number of removed LN in patients randomized to LNE was 57 (pelvic 35 and para-aortic22). Post-op platinum-taxane based chemotherapy was applied in 85% of the patients in the no-LNE arm and 80% in the LNE arm. Microscopic metastases were diagnosed in 56% of the pts in the LNE arm. Median OS in the no-LNE arm was 69 months and 66 months in the LNE arm (HR 1.06, 95%CI 0.83-1.34, p=0.65) and the median PFS was 26 months in both arms (HR 1.11, 95%CI 0.92-1.34 p=0.30). Surgery in the LNE arm was 64 minutes longer (means: 352 vs 288 min), resulted in a higher median blood loss (650 vs 500 ml), and a higher transfusion rate (67% vs 59%). Furthermore, serious post-operative complications occurred more frequently in the LNE arm (e.g. rate of re-laparotomies 12.1% vs 5.9% [p=0.006], hospital re-admittance rate 8.0% vs 3.1% [p=0.006] and deaths within 60 days after surgery 3.1 vs 0.9% [p=0.049]). Conclusions: Systematic pelvic and para-aortic LNE in patients with AOC with both intra-abdominal complete resection and clinically negative LN neither improve overall nor progression-free survival despite detecting (and removing) sub-clinical retroperitoneal lymph node metastases in 56% of the patients. Our data indicate that systematic LNE of clinical negative LN in patients with AOC and complete resection should be omitted to reduce post-operative morbidity and mortality. Clinical trial information: NCT00712218