|
CellSearch™ Circulating Tumor Cell (CTC) Test for Metastatic Breast Cancer
Now FDA cleared for prediction of progression-free survival (PFS) and overall survival (OS) in patients treated for metastatic breast cancer and as an aid in monitoring of patients with metastatic breast cancer.
Circulating tumor cells are extremely rare in healthy individuals or those with non-malignant disease. In contrast, patients with metastatic carcinomas have demonstrated variable CTCs; most notably in metastatic cancers of the breast, prostate, ovary, colon and rectum, and lung. In several case reports, the presence of CTCs has been associated with shortened survival times.
The CellSearch Circulating Tumor Cell Test is intended for the enumeration of circulating tumor cells (CTCs) of epithelial origin (CD45-, EpCAM+ and cytokeratin 8 and 18+, and/or cytokeratin 19+) in the whole blood of metastatic breast cancer patients.*
A CTC count of 5 or more per 7.5ml of blood at any time during the course of disease is predictive of shorter progression-free survival
(PFS) and overall survival (OS).
A prospective, multicenter study of 177 patients published in the NEJM demonstrated that MBC patients with a baseline measurement of fewer than
5 CTCs in 7.5 ml of whole blood had a median PFS of 7.0 months versus those with greater than five CTCs of 2.7 months. Overall survival also improved in patients with 5 or fewer CTCs from 10.1 months to greater than 18 months. The greater than or equal to 5 cell CTC cut-off proved to be a reliable estimate of disease progression and survival earlier than estimates made with traditional imaging methods as well (3-4 wks.
vs. 8-12 wks.)
*Intended for In Vitro Diagnostic Use
CellSearch™is a registered trademark of Veridex, LLC.
|
