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Clinical utility of circulating tumor cell counting through CellSearch®: the dilemma of a concept suspended in Limbo

Authors Raimondi C, Gradilone A, Naso G, Cortesi E, Gazzaniga P

Received 10 January 2014

Accepted for publication 14 February 2014

Published 17 April 2014 Volume 2014:7 Pages 619—625


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4

Cristina Raimondi,1 Angela Gradilone,1 Giuseppe Naso,2 Enrico Cortesi,2 Paola Gazzaniga1

1Dipartimento Medicina Molecolare, Sapienza Università di Roma, Rome, Italy; 2Dipartimento di Scienze Radiologiche, Oncologiche e Anatomopatologiche, Sapienza Università di Roma, Rome, Italy

Abstract: To date, 10 years after the first demonstration of circulating tumor cells (CTCs), prognostic significance in metastatic breast cancer using the US Food and Drug Administration–cleared system CellSearch®, the potential utility of CTCs in early clinical development of drugs, their role as a surrogate marker of response to therapy, and their molecular analysis for patient stratification for targeted therapies are still major unsolved questions. Great expectations are pinned on the ongoing interventional trials aimed to demonstrate that CTCs might be of value for guiding treatment of patients and predicting cancer progression. To fill the gap between theory and practice with regard to the clinical utility of CTCs, a bridge is needed, taking into account innovative design for clinical trials, a revised definition of traditional CTCs, next-generation CTC technology, the potential clinical application of CTC analysis in non-validated settings of disease, and finally, expanding the number of patients enrolled in the studies. In this regard, the results of the first European pooled analysis definitely validated the independent prognostic value of CTC counting in metastatic breast cancer patients.

Keywords: CTC, clinical trials, prognosis

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