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Ann Surg Oncol. 2019 May 7. doi: 10.1245/s10434-019-07400-0. [Epub ahead of print]

The Sentinel Lymph Node Biopsy Using Indocyanine Green Fluorescence Plus Radioisotope Method Compared With the Radioisotope-Only Method for Breast Cancer Patients After Neoadjuvant Chemotherapy: A Prospective, Randomized, Open-Label, Single-Center Phase 2 Trial.

Author information

1
Center for Breast Cancer, National Cancer Center, Goyang, Korea.
2
Department of Surgery, Wonkwang University Sanbon Hospital, Gunpo, Korea.
3
Department of Surgery, Keimyung University School of Medicine, Daegu, Korea.
4
Biometrics Research Branch, Division of Cancer Epidemiology and Management Research Institute, National Cancer Center, Goyang, Korea.
5
Center for Breast Cancer, National Cancer Center, Goyang, Korea. skkim@ncc.re.kr.
6
Center for Breast Cancer, National Cancer Center, Goyang, Korea. seeyoun@ncc.re.kr.

Abstract

BACKGROUND:

This study aimed to compare the sentinel lymph node (SLN) identification rates for breast cancer patients after neoadjuvant chemotherapy (NAC) between the dual method (DM) of indocyanine green fluorescence (ICG-F) plus a radioisotope (RI) and RI alone.

METHODS:

This randomized study enrolled 130 patients who received NAC for breast cancer and 122 patients who received SLN biopsy (SLNB) using either DM (n = 58) or RI only (n = 64). The study compared the identification rate, number of SLNs, and detection time of SLNB.

RESULTS:

Among the 122 patients, 113 (92.6%) were clinically node-positive before NAC. The SLN identification rate was 98.3% in the DM group and 93.8% in the RI group (p = 0.14). The DM group and the RI group were similar in the average number of SLNs (2.2 ± 1.13 vs. 1.9 ± 1.33; p = 0.26) and the time to detection of the first SLN (8.7 ± 4.98 vs. 8.3 ± 4.31 min; p = 0.30). In the DM group, transcutaneous lymphatic drainage was visualized by fluorescence imaging for 65.5% (38 of 58) of the patients. The SLN identification rate was 94.7% using ICG-F and 93% using RI (p = 0.79). During and after the operation, no complications, including allergic reactions or skin necrosis, occurred.

CONCLUSIONS:

This study is the first randomized trial to use ICG-F for SLNB in breast cancer patients after NAC. The DM including ICG-F could be a feasible and safe method for SLNB in initially node-positive breast cancer patients with NAC.

PMID:
31065958
DOI:
10.1245/s10434-019-07400-0

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