Evaluation of circulating tumor cells
(CTCs) allows assessment of
patient prognosis and is predictive
of progression-free survival and
overall survival
The first and only clinically validated,
FDA-cleared test for capturing and
enumerating circulating tumor cells
(CTCs) to help inform clinical decision
making
Pivotal Clinical Trial—Circulating tumor cells (CTCs) as a predictive marker of tumor
response, progression-free survival, and overall survival (OS) in patients with
mCRC1,2
Trial design
CTCs were monitored in 430 mCRC patients at baseline and after starting 1st, 2nd, or 3rd
line therapy.1
Results
References:
Cohen SJ, Punt CJA, Iannotti N, et al.
J Clin Oncol. 2008;26(19):3213-3221.
CELLSEARCH® Circulating Tumor
Cell Kit (Epithelial) Instructions for Use. Menarini Silicon Biosystems Inc.
Case Study
57-year-old male patient with mCRC with liver metastases
Stephan Cohen, MD, Associate Medical Director, Fox Chase Cancer Partners, Philadelphia,
PA
Patient history and response to treatment
Imaging in patient with mCRC showed >10 metastatic lesions in the liver
Baseline circulating tumor cells (CTCs) were 7; baseline carcinoembryonic antigen
(CEA) was 12 U/mL
Patient was initiated on aggressive chemotherapy
Within a month, the patient’s CTCs dropped to 2, indicating a favorable prognosis
Three months later, CTCs remained low and imaging confirmed stable disease SD
At that time, patient had developed grade 2 neuropathy—based on favorable CTC and
imaging results, the patient began a less aggressive treatment regimen
Thereafter, CTCs were monitored regularly; when the number of cells rose above
cutoff, imaging was performed to obtain a complete picture of the patient's
clinical status and inform clinical decisions
The clinical cutoff of CTCs per 7.5 mL of blood for
patient with mCRC is ≥3.
How CTCs helped inform the management of this patient
Results of the CELLSEARCH® CTC Test confirmed imaging and predicted poor
prognosis. After aggressive chemotherapy was initiated, CTC monitoring was used to
track the patient’s status and indicated SD for 6 months.
When the patient developed grade 2 neuropathy, low CTCs indicating favorable prognosis
and SD by imaging helped in the decision-making process to initiate a less toxic
regimen.
Thereafter, serial CTCs were measured and imaging studies were performed when CTCs rose
above the cut-off, which, for this patient, necessitated fewer overall radiological
tests. CTCs, in conjunction with imaging, helped in the clinical management of this
patient.
“With the CTC count remaining low when it had been previously elevated and imaging
study showing stable disease, I felt comfortable continuing a less intensive
regimen when neuropathy developed." — Stephan Cohen, MD
CELLSEARCH® CTC Test results should be used in
conjunction with all clinical information derived from diagnostic tests (eg,
imaging or laboratory tests), physical examination and complete medical
history, in accordance with appropriate management procedures.
This case study is for educational purposes only and does not constitute professional
medical advice. The information provided in this case study should not be
relied upon as the basis for making patient management decisions. This case
study is not intended to show that any line of therapy is any more or less
effective than any other or no therapy. Please see instructions
for use for indications and limitations of the
CELLSEARCH® CTC Test as a monitoring aid in management of
metastatic breast, colorectal, and prostate cancer.
No
References
Cohen SJ, Punt CJA, Iannotti N, et al. J Clin Oncol. 2008;26(19):3213-3221.
CELLSEARCH® Circulating Tumor Cell Kit (Epithelial) Instructions for Use. Menarini Silicon Biosystems Inc.
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