期刊
BRITISH JOURNAL OF SURGERY
卷 109, 期 12, 页码 1232-1238出版社
OXFORD UNIV PRESS
DOI: 10.1093/bjs/znac311
关键词
-
类别
资金
- National Natural Science Foundation of China [82171898]
- High-level Hospital Construction Project [DFJH202109]
- Science and Technology Planning Project of Guangzhou City [202002030236]
- Beijing Medical Award Foundation [YXJL-2020-0941-0758]
- CSCO-Hengrui Cancer Research Fund [Y-HR2016-067]
The diagnostic performance of ultrasound-assisted carbon nanoparticle suspension (CNS) mapping was comparable to that of dual tracer-guided SLN mapping with CNS plus indocyanine green (ICG) in patients with early breast cancer.
Background: Appropriate tracing methods for sentinel lymph node biopsy (SLNB) play a key role in accurate axillary staging. This prospective, non-inferiority, phase III RCT compared the feasibility and diagnostic performance of ultrasound-assisted carbon nanoparticle suspension (CNS) mapping with dual tracer-guided SLNB in patients with early breast cancer. Methods: Eligible patients had primary breast cancer without nodal involvement (cN0), or had clinically positive lymph nodes (cN1) that were downstaged to cN0 after neoadjuvant chemotherapy. Patients were randomly assigned (1 : 1) to undergo either ultrasound-assisted CNS sentinel lymph node (SLN) mapping (UC group) or dual tracer-guided mapping with CNS plus indocyanine green (ICG) (GC group). The primary endpoint was the SLN identification rate. Results: Between 1 December 2019 and 30 April 2021, 330 patients were assigned randomly to the UC (163 patients) or GC (167 patients) group. The SLN identification rate was 94.5 (95 per cent c.i. 90.9 to 98.0) per cent in the UC group and 95.8 (92.7 to 98.9) per cent in the GC group. The observed difference of -1.3 (-5.9 to 3.3) per cent was lower than the prespecified non-inferiority margin of 6 per cent (Pnoninferiority = 0.024). No significant difference was observed in metastatic node rate (30.5 versus 24.4 per cent; P= 0.222), median number of SLNs harvested (3 (range 1-7) versus 3 (1-8); P= 0.181), or duration of surgery (mean(s.d.) 7.53(2.77) versus 7.63(3.27) min; P= 0.316) between the groups. Among the subgroup of patients who had undergone neoadjuvant treatment, the SLN identification rate was 91.7 (82.2 to 100) per cent in the UC group and 90.7 (81.7 to 99.7) per cent in the GC group. Conclusion: The diagnostic performance of ultrasound-assisted CNS mapping was non-inferior to that of dual tracer-guided SLN mapping with CNS plus ICG in patients with early breast cancer.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据