Circulating tumor cells, disease progression, and survival in metastatic breast cancer

Massimo Cristofanilli*, G. Thomas Budd, Matthew J. Ellis, Alison Stopeck, Jeri Matera, M. Craig Miller, James M. Reuben, Gerald V. Doyle, W. Jeffrey Allard, Leon W M M Terstappen, Daniel F. Hayes

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3246 Scopus citations

Abstract

BACKGROUND: We tested the hypothesis that the level of circulating tumor cells can predict survival in metastatic breast cancer. METHODS: In a prospective, multicenter study, we tested 177 patients with measurable metastatic breast cancer for levels of circulating tumor cells both before the patients were to start a new line of treatment and at the first follow-up visit. The progression of the disease or the response to treatment was determined with the use of standard imaging studies at the participating centers. RESULTS: Outcomes were assessed according to levels of circulating tumor cells at baseline, before the patients started a new treatment for metastatic disease. Patients in a training set with levels of circulating tumor cells equal to or higher than 5 per 7.5 ml of whole blood, as compared with the group with fewer than 5 circulating tumor cells per 7.5 ml, had a shorter median progression-free survival (2.7 months vs. 7.0 months, P<0.001) and shorter overall survival (10.1 months vs. >18 months, P<0.001). At the first follow-up visit after the initiation of therapy, this difference between the groups persisted (progression-free survival, 2.1 months vs. 7.0 months; P<0.001; overall survival, 8.2 months vs. >18 months; P<0.001), and the reduced proportion of patients (from 49 percent to 30 percent) in the group with an unfavorable prognosis suggested that there was a benefit from therapy. The multivariate Cox proportional-hazards regression showed that, of all the variables in the statistical model, the levels of circulating tumor cells at baseline and at the first follow-up visit were the most significant predictors of progression-free and overall survival. CONCLUSIONS: The number of circulating tumor cells before treatment is an independent predictor of progression-free survival and overall survival in patients with metastatic breast cancer.

Original languageEnglish (US)
Pages (from-to)781-791
Number of pages11
JournalNew England Journal of Medicine
Volume351
Issue number8
DOIs
StatePublished - Aug 19 2004

ASJC Scopus subject areas

  • Medicine(all)

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