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) in patients with newly diagnosed mBC1, 2
Trial design
One hundred seventy-seven patients were enrolled; 83 were receiving initial therapy for mBC. Circulating tumor cells were measured at initiation of therapy and monthly thereafter for up to 6 months.1
Hayes DF, et al. Circulating Tumor Cells at Each Follow-up Time Point during Therapy of Metastatic Breast Cancer Patients Predict Progression-Free and Overall Survival Clin Cancer Res 2006;12(14): 4218-4224.
CELLSEARCH® Circulating Tumor Cell Kit (Epithelial) Instructions for Use. Menarini Silicon Biosystems Inc.
Case Study 1
57-year-old patient with mBC showing increased circulating tumor cells (CTCs) after third line of therapy
Jeffrey Bubis, DO, Integrated Community Oncology Network, Jacksonville, FL
Patient history and response to treatment
Patient presented to the emergency department in May 2006; evaluation revealed mBC to her brain and bones
Patient was treated with whole brain radiation and 6 cycles of TAC (paclitaxel, doxorubicin, and carboplatin)
Patient was disease free for 6 months, after which progressive disease was noted in the liver
Patient received 3 cycles of capecitabine and achieved a complete response
Progressive disease (PD) was noted again after 6 cycles; gemcitabine was initiated
Patient was monitored monthly for CTC counts using the CELLSEARCH® CTC Test
Four months following initiation of gemcitabine therapy, CTCs were substantially elevated above the cutoff of ≥5 CTCs. Patient remained asymptomatic
A month later, CTCs were further elevated; PET/CT scan confirmed (PD) in the liver and lungs
Patient began new treatment with paclitaxel and achieved partial response with stable disease
PD confirmed by PET/CT The clinical cutoff of CTC per 7.5 mL of blood for mBC patients is ≥5
How CTCs helped inform the management of this patient
Sustained elevated CTCs, as determined by serial monitoring of this patient, prompted an early PET/CT scan
Confirmation of PD prompted an initiation of paclitaxel before clinical manifestation of progression
Patient achieved partial response with stable disease on the fourth line of therapy
As study results have indicated that a combination of CTC testing and radiological assessments provides the most accurate assessment of prognosis, their use helped in the clinical management of this patient1
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.
CELLSEARCH® Circulating Tumor Cell Kit (Epithelial) Instructions for Use. Menarini Silicon Biosystems Inc.
Case Study 2
39-year-old patient with mBC who developed liver metastases after 49 months on aromatase inhibitor therapy
Mark Graham, MD, Waverly Hematology Oncology, Cary, NC
Patient history and response to treatment
Patient presented with a large T2 (4.5 cm), N2 grade 3 infiltrating ductal carcinoma with 6 of 24 positive axillary lymph nodes in 2002
Five years later, after 49 months of hormonal therapy, liver metastases were detected
The CELLSEARCH® CTC Test showed elevated circulating tumor cells (CTCs) of 32
Despite a recommendation of chemotherapy with bevacizumab for this visceral crisis, the patient chose to pursue aromatase inhibitor therapy with multiple complementary therapies
Monitoring with CTC tests and imaging showed progression at 6 weeks; patient began new treatment of bevacizumab/vinorelbine
On bevacizumab/vinorelbine, serial CTCs dropped to zero and imaging studies showed nonprogressive disease; patient began a less toxic regimen of bevacizumab/doxorubicin
How CTCs helped inform the management of this patient
The patient’s goal was to achieve response with minimal toxic side effects, if possible. The CELLSEARCH® CTC Test helped determine the patient’s unfavorable prognosis at baseline; however, to avoid toxic side effects, the patient chose to continue with hormone therapy.
While on aromatase inhibitor therapy, a follow-up CELLSEARCH® CTC Test indicated poor prognosis early in treatment, and together with progressive disease by imaging, based on all of these results the physician determined that a more aggressive line of treatment was advisable. After beginning the new treatment of bevacizumab/vinorelbine therapy, monitoring continued and the patient's prognosis changed to favorable based on MRI and CTC results.
As there was a drop in CTCs over the following months that demonstrated an improved prognosis on this new line of therapy, and as follow-up imaging studies showed non-progressive disease, the patient's therapy was changed to a less toxic regimen in accordance with her treatment goals.
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.
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