title: Prognostic Impact of Circulating Tumor Cell Detected Using a Novel Fluidic Cell Microarray Chip System in Patients with Breast Cancer.
abstract: Various types of circulating tumor cell (CTC) detection systems have recently been developed that show a high CTC detection rate. However, it is a big challenge to find a system that can provide better prognostic value than CellSearch in head-to-head comparison. We have developed a novel semi-automated CTC enumeration system (fluidic cell microarray chip system, FCMC) that captures CTC independently of tumor-specific markers or physical properties. Here, we compared the CTC detection sensitivity and the prognostic value of FCMC with CellSearch in breast cancer patients. FCMC was validated in preclinical studies using spike-in samples and in blood samples from 20 healthy donors and 22 breast cancer patients in this study. Using spike-in samples, a statistically higher detection rate (p=0.010) of MDA-MB-231 cells and an equivalent detection rate (p=0.497) of MCF-7 cells were obtained with FCMC in comparison with CellSearch. The number of CTC detected in samples from patients that was above a threshold value as determined from healthy donors was evaluated. The CTC number detected using FCMC was significantly higher than that using CellSearch (p=0.00037). CTC numbers obtained using either FCMC or CellSearch had prognostic value, as assessed by progression free survival. The hazard ratio between CTC+ and CTC- was 4.229 in CellSearch (95% CI, 1.31 to 13.66; p=0.01591); in contrast, it was 11.31 in FCMC (95% CI, 2.245 to 57.0; p=0.000244). CTC detected using FCMC, like the CTC detected using CellSearch, have the potential to be a strong prognostic factor for cancer patients.
authors: Department of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan; Department of Medical Oncology/Hematology, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
authors: Takeshi
authors: T
authors: Sawada
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Jungo
authors: J
authors: Araki
authors: Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan.
authors: Toshinari
authors: T
authors: Yamashita
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Manami
authors: M
authors: Masubuchi
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Tsuneko
authors: T
authors: Chiyoda
authors: Department of Breast Oncology and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
authors: Mayu
authors: M
authors: Yunokawa
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Kumiko
authors: K
authors: Hoshi
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Shoichi
authors: S
authors: Tao
authors: Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 2217-14 Hayashi-cho, Takamatsu, Kagawa 761-0395, Japan.
authors: Shohei
authors: S
authors: Yamamura
authors: Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 2217-14 Hayashi-cho, Takamatsu, Kagawa 761-0395, Japan.
authors: Shouki
authors: S
authors: Yatsushiro
authors: Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 2217-14 Hayashi-cho, Takamatsu, Kagawa 761-0395, Japan.
authors: Kaori
authors: K
authors: Abe
authors: Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 2217-14 Hayashi-cho, Takamatsu, Kagawa 761-0395, Japan.
authors: Masatoshi
authors: M
authors: Kataoka
authors: Department of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan.
authors: Tatsu
authors: T
authors: Shimoyama
authors: Department of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan.
authors: Yoshiharu
authors: Y
authors: Maeda
authors: Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan.
authors: Katsumasa
authors: K
authors: Kuroi
authors: Department of Breast Oncology and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
authors: Kenji
authors: K
authors: Tamura
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Tsuneo
authors: T
authors: Sawazumi
authors: Department of Medical Oncology/Hematology, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
authors: Hironobu
authors: H
authors: Minami
authors: Konica Minolta, Inc., 1 Sakuramachi, Hino, Tokyo 191-8511, Japan.
authors: Yoshihiko
authors: Y
authors: Suda
authors: Division of Clinical Research Support, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan. Electronic address: fkoizumi@cick.jp.
authors: Fumiaki
authors: F
authors: Koizumi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000401:mortality* / Q000628:therapy; D016022:Case-Control Studies; D002452:Cell Count; D045744:Cell Line, Tumor; D018450:Disease Progression; D005260:Female; D006801:Humans; D046210:Microfluidic Analytical Techniques / Q000295:instrumentation / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging; D009360:Neoplastic Cells, Circulating / Q000473:pathology*; D011379:Prognosis; D016896:Treatment Outcome
keywords: Breast cancer; CellSearch; Circulating tumor cell; Fluidic cell microarray chip; Prognostic marker