Clinical Practice Status of Sentinel Lymph Node Biopsy for Early-Stage Breast Cancer Patients in China: A Multicenter Study

Abstract

Background

Sentinel lymph node biopsy (SLNB) was introduced over 30 years ago, but the application of SLNB in China is unclear. This study aimed to explore the real-world implementation of SLNB among early-stage breast cancer patients in China.

Methods

A multi-center, retrospective study was conducted among primary breast cancer patients from 37 hospitals in China in 2018. Their clinical data were collected and analyzed, including the implementation status of SLNB in China, subsequent processing of sentinel lymph nodes (SLNs) containing metastases, and the effect of neoadjuvant chemotherapy (NAC) on SLNB.

Results

SLNB surgery was performed on 43.5% of early-stage breast cancer patients in China and 11,942 patients who underwent SLNB were enrolled in this study. The majority of SLNBs were performed using a single mapping agent. A combination of blue dye and radiotracer or fluorescence imaging was used in only 14.9% of patients. The mean (SD) number of resected SLNs was 4.0 (2.1). For the patients with 1 or 2 positive SLNs, 83.0% of them continued to receive axillary lymph node dissection (ALND), while others did not. For the patients with three or more positive SLNs, 97.2% of them continued to receive ALND, among which 82.9% accepted radiotherapy simultaneously. Of the patients who underwent SLN surgery, 5.5% (654/11,942) were receiving NAC. Among them, 51.9% received SLNB before NAC, and the rest received SLNB after NAC. In biopsy-proven positive nodes, 64.7% positive SLNs turned negative after NAC.

Conclusion

SLNB has been promoted in China, but it is not widely used compared to in developed countries. Furthermore, the usage of the dual tracer technique in SLNB is not high. Chinese breast surgeons are more conservative regarding the omission of ALND in 1 or 2 SLNs-positive patients.

Keywords:

• sentinel lymph node
• early-stage breast cancer
• real word data

Acknowledgments

The authors are grateful for the assistance of the Breast Surgery Group of the Chinese Medical Association Surgery Society and the data providers in Beijing Chaoyang Hospital, Peking University First Hospital, Peking University People’s Hospital, Xuanwu Hospital of Capital Medical University, Beijing Friendship Hospital, The Second Hospital of Dalian Medical University, Fujian Medical University Union Hospital, The Obstetrics & Gynecology Hospital of Fudan University, Huashan Hospital of Fudan University, Zhongshan Hospital of Fudan University, Gansu Provincial Hospital, Gansu Provincial Cancer Hospital, Affiliated Wudang Hospital of Guizhou Medical University, The Second Affiliated Hospital of Harbin Medical University, The Fourth Hospital of Hebei Medical University, Henan Cancer Hospital, The First Affiliated Hospital of Jilin University, Jilin Cancer Hospital, Jiangsu Province Hospital, The General Hospital of the People’s Liberation Army, Xijing Hospital, The First Hospital of Lanzhou University, The Second Hospital of Lanzhou University, Southwest Hospital, The Second Affiliated Hospital of Nanchang University, Inner Mongolia Autonomous Region People’s Hospital, Second Hospital of Shandong University, Shandong Provincial Western Hospital, Sichuan Provincial People’s Hospital, Affiliated Cancer Hospital of Xinjiang Medical University, Yunnan Cancer Hospital, The First Affiliated Hospital of Zhejiang University, The Second Affiliated Hospital of Zhejiang University, The First Hospital of China Medical University, Shengjing Hospital of China Medical University, Xiangya Hospital Central South University, and Sun Yat-sen Memorial Hospital of Sun Yat-sen University.

Abbreviations

SLNB, sentinel lymph node biopsy; SLNs, sentinel lymph nodes; ALND, axillary lymph node dissection; NAC, neoadjuvant chemotherapy; NIR, near-infrared; 99-Tc, 99 m-Technetium; ICG, indocyanine green.

Data Sharing Statement

Major findings from the study will be published in scientific manuscripts. The data will be made available on request. In order to preserve the privacy of the patients in compliance with local laws and regulations, data related to patient privacy (name, hospitalization number) will not be available.

Ethics Approval and Informed Consent

Protocols for SLNB and evaluation of data in the retrospective study followed the principles of the Declaration of Helsinki and was approved by the Ethical Committee of Xijing Hospital, The Fourth Military Medical University (KY20192114-C-1). The clinical trial ID of this study is NCT04156841.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This paper was funded by Key R&D Program of Shaanxi Province, China. (No. 2018ZDXM-SF-066).