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Published in: Annals of Surgical Oncology 1/2016

01-01-2016 | Breast Oncology

Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer

Authors: Tomoharu Sugie, MD, PhD, Takayuki Kinoshita, MD, PhD, Norikazu Masuda, MD, PhD, Terumasa Sawada, MD, PhD, Akira Yamauchi, MD, PhD, Katsumasa Kuroi, MD, PhD, Tetsuya Taguchi, MD, PhD, Hiroko Bando, MD, PhD, Hiroyasu Yamashiro, MD, PhD, Tecchuu Lee, MD, PhD, Nobuhiko Shinkura, MD, PhD, Hironori Kato, MD, PhD, Takafumi Ikeda, PhD, Kenichi Yoshimura, PhD, Hanae Ueyama, PhD, Masakazu Toi, MD, PhD

Published in: Annals of Surgical Oncology | Issue 1/2016

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Abstract

Purpose

This study compared the clinical utility of indocyanine green (ICG) fluorescence and radioisotope (RI) for sentinel lymph node (SLN) detection in breast cancer.

Methods

Women with node-negative breast cancer underwent SLN biopsy using ICG fluorescence and RI. The primary end point was the sensitivity of ICG fluorescence compared with RI in the patients with tumor-positive SLNs. Secondary end points included detection rates for SLN, the additive effect of ICG fluorescence to RI, signature of positive SLNs according to tier, and adverse events related to ICG administration.

Results

A total of 847 women with clinical node-negative breast cancer underwent SLN biopsy, and 821 patients were included in the per-protocol analysis. SLN mapping was performed using ICG fluorescence and RI. The overall detection of SLNs using ICG fluorescence was identical to RI (97.2 vs. 97.0 %, P = 0.88), and the combination of both methods achieved a significant improvement compared with RI alone (99.8 vs. 97.0 %, P < 0.001). The detection rate for tumor-positive SLN was 93.3 % for ICG fluorescence and 90.0 % for RI, and the sensitivity of the ICG fluorescence method was 95.7 % (95 % CI 91.3–98.3, P = 0.11). The additional use of ICG significantly improved positive SLN detection for RI (97.2 vs. 90.0 %, P < 0.001). There were no serious adverse events related to hypersensitivity to ICG.

Conclusions

The ICG fluorescence method may be an acceptable alternative to SLN detection using RI in breast cancer.
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Metadata
Title
Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer
Authors
Tomoharu Sugie, MD, PhD
Takayuki Kinoshita, MD, PhD
Norikazu Masuda, MD, PhD
Terumasa Sawada, MD, PhD
Akira Yamauchi, MD, PhD
Katsumasa Kuroi, MD, PhD
Tetsuya Taguchi, MD, PhD
Hiroko Bando, MD, PhD
Hiroyasu Yamashiro, MD, PhD
Tecchuu Lee, MD, PhD
Nobuhiko Shinkura, MD, PhD
Hironori Kato, MD, PhD
Takafumi Ikeda, PhD
Kenichi Yoshimura, PhD
Hanae Ueyama, PhD
Masakazu Toi, MD, PhD
Publication date
01-01-2016
Publisher
Springer US
Published in
Annals of Surgical Oncology / Issue 1/2016
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-015-4809-4

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