在乳腺癌中省略椎解剖与哨兵节点转移
Jana de Boniface1, Tove Filtenborg Tvedskov1, Lisa Rydén1
1From the Departments of Molecular Medicine and Surgery (J.B., M.A., H.S., J.F.) and Medical Epidemiology and Biostatistics (R.S.), Karolinska Institutet, the Department of Surgery, Capio St. Göran's Hospital (J.B., M.A., S.N.), Cytel (R.S.), the Department of Surgery, Södersjukhuset (F.C.), and Breast Center Karolinska, Karolinska Comprehensive Cancer Center, Karolinska University Hospital (H.S., J.F.), Stockholm, the Faculty of Medicine, Institute of Clinical Sciences, Lund University (L.R., S.A.), and the Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital Lund (S.A.), Lund, the Department of Gastroenterology and Surgery (L.R.), and Radiation Physics, Department of Hematology, Oncology, and Radiation Physics (E.W.), Skåne University Hospital Lund, Malmö, the Departments of Surgery (R.O.B.) and Oncology (D.L.), Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg University, and the Departments of Surgery (R.O.B.) and Oncology (D.L.), Sahlgrenska University Hospital, Gothenburg, the Department of Diagnostics and Intervention-Surgery, Umeå University, Umeå (M.S.), the Department of Oncology, Faculty of Medicine and Health, Örebro University, Örebro (J.A.), Regional Cancer Center of Mid-Sweden, Uppsala (J.A.), the Department of Surgery, Skaraborg Hospital, Lidköping (P.F.N.), the Department of Biomedical and Clinical Sciences (E.V.P.), Linköping University, and the Department of Surgery, Linköping University Hospital (E.V.P.), Linköping, and the Department of Surgery (Y.A.) and the Center for Clinical Research, Uppsala University and Region Vastmanland, Vastmanland Hospital (Y.A., L.B.), Vasteras - all in Sweden; the Faculty of Health and Medical Sciences, University of Copenhagen (T.F.T.), the Department of Breast Surgery, Gentofte Hospital, Gentofte (T.F.T.), the Department of Surgery, Breast Clinic, Viborg Hospital, Viborg (I.S.A.), the Department of Plastic and Breast Surgery, Aalborg University Hospital, Aalborg (U.H.), the Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle (H.D.N.), and the Departments of Oncology (B.V.O.) and Plastic and Breast Surgery (P.C.), Aarhus University Hospital, the Departments of Oncology (B.V.O.) and Clinical Medicine (P.C.), Aarhus University, and the Department of Experimental Clinical Oncology, Danish Center for Particle Therapy (B.V.O.), Aarhus - all in Denmark; the Department of Obstetrics and Gynecology, University of Rostock, Rostock (T.R.), the Breast Center, Die Filderklinik, Filderstadt (T.K.), and the Department of Gynecology and Obstetrics, University of Ulm, Ulm (T.K.) - all in Germany; the First Department of Surgery, National and Kapodistrian University of Athens, Athens (M.K.); the Department of Breast Surgery, IRCCS Ospedale San Raffaele (O.D.G.), and Vita-Salute San Raffaele University (O.D.G.) - both in Milan; and the Department of Surgery, University of Helsinki and Helsinki University Hospital, Helsinki (M.S.).
在带有哨戒节点巨型转移的节点阴性乳腺癌患者中,省略完成带淋巴结解剖,与解剖无差. 这一发现支持在保持无复发生存率的同时,进行较少的广泛手术.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 临床试验 临床试验
背景情况:
- 之前的关于遗漏状淋巴结解剖 (ALND) 在带有哨兵结转移的节点负性乳腺癌的试验面临限制.
- 这些局限性包括不够的统计能力,不清楚的放射治疗目标体积,以及缺乏关于特定患者子组的数据.
研究的目的:
- 为了评估单独的哨戒节点活检 (SNB) 与完成ALND相比,单独的哨戒节点活检在临床上阴性乳腺癌和哨戒节点大转移的患者中的非劣势性.
- 在这个患者群体中,评估无复发生存率作为次要终点.
主要方法:
- 一项非劣势性随机对照试验 (SENOMAC) 涉及2766名患有原发性T1-T3节点阴性乳腺癌和1-2哨戒节点宏观转移的患者.
- 患者被随机分配1:1只给SNB或完成ALND. 辅助治疗遵循国家指导方针.
- 主要终点是整体存活率;次要终点是无复发性存活率,非劣势性以复发或死亡的危险比率<1.44来定义.
主要成果:
- 该研究包括2540名患者在每协议分析中 (1335名SNB,1205名ALND).
- 随访时间中位数为46.8个月. 估计的5年无复发生存率仅为SNB为89.7%,仅为ALND为88.7%.
- 复发或死亡的危险比为0.89 (95% CI,0.66至1.19),明显低于1.44的非劣势率 (P<0.001).
结论:
- 在精选的乳腺癌患者中,没有完成带-淋巴结剖析,与更广泛的手术无差.
- 这种方法是安全有效的,特别是与节点放射治疗相结合时,该疗法被用于试验中的大多数患者.
- 这些发现支持降低对乳腺癌患者的手术治疗的升级,而这些患者的哨戒节点参与程度有限.
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