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关于晚期卵巢肿瘤患者淋巴结清扫术的随机试验
A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms


Philipp Harter ... 肿瘤 妇产科和儿科 • 2019.02.28
NEJM 动画解读

晚期卵巢癌的淋巴结清扫术
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• 卵巢癌的腹腔热灌注化疗 • 卵巢癌筛查能够改善(某些人群的)生存率

LION研究为妇科肿瘤医师带来的思考

 

高庆蕾

华中科技大学同济医学院附属同济医院妇产科

 

淋巴结转移是实体瘤的主要转移途径。淋巴结清扫(即切除肿瘤附近的淋巴结组织)可以降低部分肿瘤的转移概率,延长患者生存时间,是大多数实体瘤指南推荐的手术方式。然而,对于晚期卵巢癌淋巴结清扫的利与弊,妇科肿瘤界争论了几十年。2019年2月28日发表于《新英格兰医学杂志》(NEJM)的《关于晚期卵巢肿瘤患者淋巴结清扫术的随机试验》论著,是否能为这一争论画上句号?

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摘要


背景

系统性盆腔和主动脉旁淋巴结清扫术已被广泛用于晚期卵巢癌患者的外科治疗,但来自随机临床试验的支持证据有限。

 

方法

在术中,我们将新诊断为晚期卵巢癌(国际妇产科联合会[International Federation of Gynecology and Obstetrics,FIGO]分期ⅡB期至Ⅳ期)、已接受肉眼完全切除术且术前和术中淋巴结正常的患者随机分组,分别接受或不接受淋巴结清扫术。所有研究中心在参与本试验之前必须经过手术技能方面的资格认证。主要终点是总生存期。

 

结果

从2008年12月至2012年1月,共计647例患者被分配接受淋巴结清扫术(323例患者)或不接受淋巴结清扫术(324例患者),并被纳入分析。在接受淋巴结清扫术的患者中,切除的淋巴结个数中位数为57个(35个盆腔淋巴结和22个主动脉旁淋巴结)。非淋巴结清扫术组和淋巴结清扫术组的中位总生存期分别为69.2个月和65.5个月(淋巴结清扫术组死亡的风险比,1.06;95%置信区间[CI],0.83~1.34;P=0.65),两组的中位无进展生存期为25.5个月(淋巴结清扫术组进展或死亡的风险比,1.11;95% CI,0.92~1.34;P=0.29)。淋巴结清扫术组的严重术后并发症发生率较高(例如再次开腹的发生率,12.4% vs. 6.5%[P=0.01];术后60日内的死亡率,3.1% vs. 0.9%[P=0.049])。

 

结论

在已接受腹腔内肉眼完全切除术且术前和术中淋巴结正常的晚期卵巢癌患者中,进行系统性盆腔和主动脉旁淋巴结清扫术与不进行淋巴结清扫术相比,未达到较长的总生存期或无进展生存期,并且与较高的术后并发症发生率相关(由德国研究基金会[Deutsche Forschungsgemeinschaft]和奥地利科学基金[Austrian Science Fund]资助;LION在ClinicalTrials.gov注册号为NCT00712218)。 





作者信息

Philipp Harter, M.D., Ph.D., Jalid Sehouli, M.D., Ph.D., Domenica Lorusso, M.D., Alexander Reuss, M.Sc., Ignace Vergote, M.D., Ph.D., Christian Marth, M.D., Ph.D., Jae-Weon Kim, M.D., Ph.D., Francesco Raspagliesi, M.D., Ph.D., Björn Lampe, M.D., Ph.D., Giovanni Aletti, M.D., Werner Meier, M.D., Ph.D., David Cibula, M.D., Ph.D., Alexander Mustea, M.D., Ph.D., Sven Mahner, M.D., Ph.D., Ingo B. Runnebaum, M.D., Ph.D., Barbara Schmalfeldt, M.D., Ph.D., Alexander Burges, M.D., Ph.D., Rainer Kimmig, M.D., Ph.D., Giovanni Scambia, M.D., Ph.D., Stefano Greggi, M.D., Ph.D., Felix Hilpert, M.D., Ph.D., Annette Hasenburg, M.D., Ph.D., Peter Hillemanns, M.D., Ph.D., Giorgio Giorda, M.D., Ingo von Leffern, M.D., Carmen Schade-Brittinger, B.Sc., Uwe Wagner, M.D., Ph.D., and Andreas du Bois, M.D., Ph.D.
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.). Address reprint requests to Dr. Harter at the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft, Henricistr. 92, 45136 Essen, Germany, or at p.harter@gmx.de.

 

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