Tomoharu Sugie1, Takayuki Kinoshita2, Norikazu Masuda3, Terumasa Sawada4, Akira Yamauchi5, Katsumasa Kuroi6, Tetsuya Taguchi7, Hiroko Bando8, Hiroyasu Yamashiro9, Tecchuu Lee10, Nobuhiko Shinkura11, Hironori Kato12, Takafumi Ikeda13, Kenichi Yoshimura14, Hanae Ueyama13, Masakazu Toi15. 1. Department of Surgery, Kansai Medical University, Hirakata, Japan. sugiet@hirakata.kmu.ac.jp. 2. National Cancer Center Hospital, Tokyo, Japan. 3. National Hospital Organization Osaka National Hospital, Osaka, Japan. 4. Department of Breast Surgery Oncology, Showa University School of Medicine, Tokyo, Japan. 5. Tazuke-Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan. 6. Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan. 7. Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan. 8. Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan. 9. Tenri Hospital, Tenri, Japan. 10. Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan. 11. Kyoto Breast Center Sawai Memorial Clinic, Kyoto, Japan. 12. Kobe City Medical Center General Hospital, Kobe, Japan. 13. Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan. 14. Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan. 15. Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
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.
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.