Circulating Tumor Cells, Disease Progression, and Survival in Metastatic Breast Cancer

doi:10.1056/NEJMoa040766

Volume 351:781-791		August 19, 2004		Number 8

Circulating Tumor Cells, Disease Progression, and Survival in Metastatic Breast Cancer

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

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ABSTRACT

Background We tested the hypothesis that the level of circulatingtumor cells can predict survival in metastatic breast cancer.

Methods In a prospective, multicenter study, we tested 177 patientswith measurable metastatic breast cancer for levels of circulatingtumor cells both before the patients were to start a new lineof treatment and at the first follow-up visit. The progressionof the disease or the response to treatment was determined withthe use of standard imaging studies at the participating centers.

Results Outcomes were assessed according to levels of circulatingtumor cells at baseline, before the patients started a new treatmentfor metastatic disease. Patients in a training set with levelsof circulating tumor cells equal to or higher than 5 per 7.5ml of whole blood, as compared with the group with fewer than5 circulating tumor cells per 7.5 ml, had a shorter median progression-freesurvival (2.7 months vs. 7.0 months, P<0.001) and shorteroverall 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-freesurvival, 2.1 months vs. 7.0 months; P<0.001; overall survival,8.2 months vs. >18 months; P<0.001), and the reduced proportionof patients (from 49 percent to 30 percent) in the group withan unfavorable prognosis suggested that there was a benefitfrom therapy. The multivariate Cox proportional-hazards regressionshowed that, of all the variables in the statistical model,the levels of circulating tumor cells at baseline and at thefirst follow-up visit were the most significant predictors ofprogression-free and overall survival.

Conclusions The number of circulating tumor cells before treatmentis an independent predictor of progression-free survival andoverall survival in patients with metastatic breast cancer.

Source Information

From the M.D. Anderson Cancer Center, Houston (M.C., J.M.R.); the Cleveland Clinic, Cleveland (G.T.B.); Duke University, Durham, N.C. (M.J.E.); the University of Arizona, Tucson (A.S.); Immunicon, Huntingdon Valley, Pa. (J.M., M.C.M., G.V.D., W.J.A., L.W.M.M.T.); and the University of Michigan Comprehensive Cancer Center, Ann Arbor (D.F.H.).

Address reprint requests to Dr. Cristofanilli at the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Box 424, Houston, TX 77030, or at mcristof{at}mdanderson.org.

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N Engl J Med 2004; 351:2452-2454, Dec 2, 2004. Correspondence

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