Prognostic value of HER2-positive circulating tumor cells in patients with metastatic breast cancer

Naoki Hayashi, Seigo Nakamura, Yasuharu Tokuda, Yuji Shimoda, Hiroshi Yagata, Atsushi Yoshida, Hidekazu Ota, Gabriel N. Hortobagyi, Massimo Cristofanilli, Naoto T. Ueno*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

73 Scopus citations


Backgrounds The presence of ≥5 circulating tumor cells (CTCs) in 7.5 ml blood is a poor prognostic marker in metastatic breast cancer (MBC). However, the role of human epidermal growth factor receptor 2 (HER2) status in CTCs is not known. Methods We prospectively assessed the prognostic value of this parameter for patients with MBC who started a new line of systemic therapy. The CTC count (≥5 or <5) and the HER2 status in CTCs at the initiation of the therapy and 3-4 weeks later (first follow-up) were determined. Results The median follow-up time of the 52 enrolled patients was 655.0 days (18-1,275 days). HER2-positive CTCs were present in 14 of the 52 patients (26.9%) during the study period. Eight of 33 patients (24.2%) with HER2-negative primary tumors had HER2-positive CTCs during the study period. At first follow-up, patients with HER2-positive CTCs had significantly shorter progression-free (n = 6; P = 0.001) and overall (P = 0.013) survival than did patients without HER2-positive CTCs (n = 43) in log-rank analysis. In multivariate analysis, HER2-positive CTCs at first follow-up (P = 0.029) and the number of therapies patients received before this study (P = 0.006) were independent prognostic factors in terms of progression-free survival. The number of therapies (P = 0.001) and a count of ≥5 CTCs (P = 0.043) at baseline were independent prognostic factors in terms of overall survival. Conclusions We showed that HER2 status in CTCs may be a prognostic factor for MBC. Well-powered prospective studies are necessary to determine the potential role of HER2-targeted therapies for patients with HER2-positive CTCs and HER2-negative primary tumors.

Original languageEnglish (US)
Pages (from-to)96-104
Number of pages9
JournalInternational Journal of Clinical Oncology
Issue number2
StatePublished - Apr 2012


  • Breast neoplasm
  • Circulating tumor cell
  • HER2
  • Metastasis

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Surgery


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