Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer.
OBJECTIVE
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.
Department of Surgery, Kansai Medical University, Hirakata, Japan. sugiet@hirakata.kmu.ac.jp.
Tomoharu
T
Sugie
National Cancer Center Hospital, Tokyo, Japan.
Takayuki
T
Kinoshita
National Hospital Organization Osaka National Hospital, Osaka, Japan.
Norikazu
N
Masuda
Department of Breast Surgery Oncology, Showa University School of Medicine, Tokyo, Japan.
Terumasa
T
Sawada
Tazuke-Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan.
Akira
A
Yamauchi
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Katsumasa
K
Kuroi
Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Tetsuya
T
Taguchi
Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiroko
H
Bando
Tenri Hospital, Tenri, Japan.
Hiroyasu
H
Yamashiro
Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
Tecchuu
T
Lee
Kyoto Breast Center Sawai Memorial Clinic, Kyoto, Japan.
Nobuhiko
N
Shinkura
Kobe City Medical Center General Hospital, Kobe, Japan.
Hironori
H
Kato
Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Takafumi
T
Ikeda
Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan.
Kenichi
K
Yoshimura
Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Hanae
H
Ueyama
Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Masakazu
M
Toi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology* / Q000601:surgery; D004396:Coloring Agents; D005260:Female; D005453:Fluorescence; D005500:Follow-Up Studies; D006801:Humans; D007208:Indocyanine Green; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D015609:Organotechnetium Compounds; D011379:Prognosis; D011446:Prospective Studies; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D021701:Sentinel Lymph Node Biopsy; D055815:Young Adult
D004396:Coloring Agents; D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; D007208:Indocyanine Green