Circulating tumor cells: A novel prognostic factor for newly diagnosed metastatic breast cancer

Massimo Cristofanilli, Daniel F. Hayes, G. Thomas Budd, Mathew J. Ellis, Alison Stopeck, James M. Reuben, Gerald V. Doyle, Jeri Matera, W. Jeffrey Allard, M. Craig Miller, Herbert A. Fritsche, Gabriel N. Hortobagyi, Leon W.M.M. Terstappen

Research output: Contribution to journalArticlepeer-review

919 Scopus citations


Purpose: Metastatic breast cancer (MBC) is incurable; its treatment is palliative. We investigated whether the presence of circulating tumor cells (CTCs) predicts treatment efficacy, progression-free survival (PFS), and overall survival (OS) in patients with newly diagnosed MBC who were about to start first-line therapy. Patients and Methods: One hundred seventy-seven patients with measurable MBC were enrolled onto a prospective study. Eighty-three of the 177 patients were entering first-line treatment, and these patients are the focus of this analysis. CTCs from 7.5 ml_ of whole blood drawn before treatment initiation (baseline) and monthly thereafter for up to 6 months were isolated and enumerated using immunomagnetics. Results: The mean (± standard deviation) follow-up time was 11.1 ± 4.4 months (median, 12.2 months). Forty-three patients (52%) had ≥ five CTCs at baseline. The median PFS was 7.2 months (95% CI, 4.9 to 9.4 months), and the median OS was more than 18 months. Patients with ≥ five CTCs at baseline and at first follow-up (4 weeks) had a worse prognosis than patients with less than five CTCs (baseline: median PFS, 4.9 v 9.5 months, respectively; log-rank, P = .0014; median OS, 14.2 v > 18 months, respectively; log-rank, P = .0048; first follow-up: median PFS, 2.1 v 8.9 months, respectively; log-rank, P = .0070; median OS, 11.1 v > 18 months, respectively; log-rank, P = .0029). CTCs before and after the initiation of therapy were strong, independent prognostic factors. Conclusion: Detection of CTCs before initiation of first-line therapy in patients with MBC is highly predictive of PFS and OS. This technology can aid in appropriate patient stratification and design of tailored treatments.

Original languageEnglish (US)
Pages (from-to)1420-1430
Number of pages11
JournalJournal of Clinical Oncology
Issue number7
StatePublished - 2005

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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