在NAUTILUS临床试验中的临床病理特征和淋巴结状况:KBCSG-21-21
Jai Min Ryu1, Han-Byoel Lee2, Wonshik Han2
1Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
概括
该NAUTILUS试验评估了在早期乳腺癌中省略哨兵淋巴结活检 (SLNB). 结果显示,状淋巴结转移率因瘤大小而异,在特定患者群体中告知SLNB遗漏.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 乳腺癌研究研究 乳腺癌研究
背景情况:
- 在NAUTILUS试验中,评估了在早期乳腺癌 (cT1-2/N0) 中省略哨戒淋巴结活检 (SLNB) 的非劣势性.
- 本报告详细介绍了NAUTILUS试验中的临床病理特征和状淋巴结 (ALN) 状态.
- 研究结果与SOUND和INSEMA试验进行了背景分析,特别是针对50岁及以上的参与者.
研究的目的:
- 在NAUTILUS试验的SLNB分支中分析临床病理学变量和ALN状态.
- 通过将NAUTILUS试验结果与其他相关临床试验进行比较,确定对NAUTILUS试验结果的预期.
- 为决策过程提供有关早期乳腺癌中SLNB遗漏的相关数据.
主要方法:
- 随机将1734名受试者分为SLNB或非SLNB组.
- 强制性腹超声波检查,以确认临床N0状态.
- 在SLNB手臂中分析临床病理变量和ALN状态.
主要成果:
- 1664名受试者可供分析;SLNB组的50.4%,非SLNB组的49.6%.
- 平均年龄为55岁; 40.1%为绝经前.
- 在SLNB手臂中的11.2%的患者患有ALN转移,其发病率随着瘤大小的增加而增加 (≤1.0厘米的7.0%,≥2.0和≤5.0厘米的17.2%).
结论:
- NAUTILUS试验招募了14.0%的pT2和40.1%的绝经前状态的患者.
- 该试验预计将证明在这些特定子组中省略SLNB的影响.
- 结果将有助于理解SLNB在早期乳腺癌管理中的缺失.
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