护卫结宏观转移患者的手术:随机INSEMA试验的二次结果
Toralf Reimer1, Angrit Stachs2, Kristina Veselinovic3
1Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany. toralf.reimer@kliniksued-rostock.de.
NPJ breast cancer
|January 27, 2026
概括
单独的哨兵淋巴结活检 (SLNB) 相当于完成状淋巴结剖析 (cALND),用于早期乳腺癌患者的无侵袭性疾病生存. 这项研究发现,这两种手术方法在生存或复发方面没有显著差异.
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:
- 轴心淋巴结状况对于乳腺癌的分期和治疗决策至关重要.
- 完成状淋巴结解剖 (cALND) 已经成为患有巨型转移的患者的标准,但单独的哨兵淋巴结活检 (SLNB) 正被研究为一种不那么侵入性的替代方案.
研究的目的:
- 为了比较单独的SLNB与cALND在T1/T2侵袭性乳腺癌和1-3阳性哨戒节点的患者中的疗效.
- 评估单独的SLNB与cALND相比,在无侵袭性疾病生存期 (iDFS) 中的非劣势.
主要方法:
- 一项INSEMA试验 (随机化-2) 的子研究,涉及T1/T2侵袭性乳腺癌和哨戒节点宏观转移的cN0患者.
- 患者接受了提前的乳房保护手术.
- 单独的SLNB (N=217) 和cALND (N=169) 之间的比较,每项协议设置中,随访时间中位数为74.2个月.
主要成果:
- 五年期的iDFS显示出非显著差异 (危险比率1.69;P=0.058),仅SLNB的比率为86.6%,cALND的比率为93.8%.
- 仅SLNB的五年整体存活率为94.9%,cALND的96.2% (P=0.663).
- 局部复发不常见,仅SLNB的5年发病率为1.1%,对cALND的0.0% (P=0.405).
结论:
- 单独的SLNB是选择乳腺癌患者的安全和有效替代cALND的替代品,其中有有限的哨戒节点参与.
- 在两种手术方法之间没有观察到无侵袭性疾病生存率,总生存率或局部区域复发的显著差异.
- 这些发现支持在特定的乳腺癌患者群体中缓解手术的升级.
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