中国乳腺癌微创腋窝评估十年荧光路

　　前哨淋巴结活检是早期乳腺癌腋窝淋巴结临床阴性患者腋窝分期的标准手术方法，可减少不必要的腋窝淋巴结清扫及其上肢淋巴水肿并发症风险。目前，同位素大分子联合蓝色染料双示踪法仍为前哨淋巴结活检的金标准。由于同位素存在可获得性和辐射性安全问题，不含同位素的吲哚菁绿荧光染料联合亚甲蓝（美蓝）双示踪法成为近年来的研究热点。十年前，北京大学人民医院在国内率先将该技术应用于临床，随机对照研究结果表明，该技术检出的前哨淋巴结显著多于单用亚甲蓝示踪检出的前哨淋巴结，而且可以检出未被亚甲蓝染色的阳性淋巴结，可获得性和成本也符合中国国情。

　　2021年3月24日，施普林格自然旗下《乳腺癌研究与治疗》在线发表北京大学人民医院王朝斌、佟富中、曹迎明、刘鹏、周波、刘宏军、程琳、刘淼、郭嘉嘉、谢菲、杨后圃、王思源、彭媛、王殊等学者的中国早期乳腺癌患者吲哚菁绿＋亚甲蓝双示踪前哨淋巴结活检长期随访结果。

ACTRN12612000109808: A Randomized Trial Compared the Efficacy and Safety of Combined Use of Indocyanine Green Fluorescence and Methylene Blue Dye Versus Methylene Blue Dye alone for Sentinel Lymph Node Biopsy in Breast Cancer Patients

　　该单中心前瞻队列研究对2011年1月～2015年12月北京大学人民医院乳腺中心连续1061例早期乳腺癌吲哚菁绿＋亚甲蓝双示踪前哨淋巴结活检患者的前哨淋巴结检出率、数量、阳性率、腋窝复发率、上肢淋巴水肿发生率进行分析。

　　结果，吲哚菁绿＋亚甲蓝与单用亚甲蓝相比：

  • 前哨淋巴结检出率：99.6%比93.9%（P<0.001）

  • 前哨淋巴结中位数：3枚比2枚（P<0.001）

  • 前哨淋巴结阳性者：96.6%比84.8%（P<0.001）

  • 前哨淋巴结阳性率：94.1%比69.3%（P<0.001）

　　经过2～9.3年（中位5.6年）随访，前哨淋巴结阴性患者同侧腋窝复发率仅0.64%；上肢淋巴水肿发生率仅2.1%，显著低于进行腋窝淋巴结清扫的前哨淋巴结阳性患者（14%，P<0.001）。

　　因此，该研究结果表明，吲哚菁绿＋亚甲蓝双示踪是早期乳腺癌患者前哨淋巴结活检的有效方法。该研究立足临床、立足国情，为中国乳腺癌患者微创腋窝评估提供了新方法和高水平证据。

Breast Cancer Res Treat. 2021 Mar 24. Online ahead of print.

Long-term follow-up results of fluorescence and blue dye guided sentinel lymph node biopsy in early breast cancer.

Wang C, Tong F, Cao Y, Liu P, Zhou B, Liu H, Cheng L, Liu M, Guo J, Xie F, Yang H, Wang S, Peng Y, Wang S.

Peking University People's Hospital, Beijing, China.

PURPOSE: This study aimed to assess the efficacy of the combination of indocyanine green (ICG) and methylene blue (MB) dye in early breast cancer patients undergoing sentinel lymph node biopsy (SLNB).

METHODS: Between January 2011 and December 2015, 1061 early breast cancer patients underwent SLNB were included. SLNB was performed for enrolled patients by injection of both ICG and MB. Detection rate, positivity, and number of sentinel lymph nodes (SLNs) by ICG and MB were analysed. Axillary recurrence and arm lymphedema at 5.6-year follow-up were reported.

RESULTS: The combination of ICG and MB resulted in a very high detection rate of 99.6%, the median number of sentinel lymph nodes was 3. A total of 374 histologically confirmed positive SLNs were detected in 237 patients, 96.6% of the positive patients and 94.1% of the positive nodes could be identified by the combination of ICG and MB. After a median follow-up of 5.6 (2-9.3) years, 0.64% of patients with negative SLNs had ipsilateral axillary recurrence, and the incidence of arm lymphedema was 2.1%.

CONCLUSIONS: Although the missing isotope control weakens the interpretation of the findings, the dual tracing modality of ICG and MB, without involvement of radioactive isotopes, was an effective method for SLNB in patients with early breast cancer.

TRIAL REGISTRATION: ACTRN12612000109808

KEYWORDS: Axillary recurrence; Breast cancer; Indocyanine green; Lymphedema; Sentinel lymph node biopsy

PMID: 33761081

DOI: 10.1007/s10549-021-06196-6

（来源：SIBCS）

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