Monitoring Circulating Tumor Cells With the CellSearch(R) System Can Predict Prognosis...

Monitoring Circulating Tumor Cells With the CellSearch(R) System Can Predict
Prognosis in Metastatic Breast Cancer
New Study Reinforces Important Role of Integrating Therapeutic Monitoring
Tools

RARITAN, N.J., July 13 /PRNewswire/ -- Measuring the change in circulating
tumor cell (CTC) count can accurately predict the prognosis and survival in
patients with metastatic breast cancer (MBC), according to a newly published
report in the July 10 issue of the Journalof Clinical Oncology. The
retrospective study compared how well CTCs and a more sensitive than
conventional modality, fluorodeoxyglucose positron emission
tomography/computed tomography (FDG-PET/CT), predicted survival in MBC
patients on standard therapies. The comparison showed that both technologies
significantly correlate to overall MBC patient survival (p<0.001 for CTCs and
p=0.001 for FDG-PET/CT). However, a CTC count of five or more could better
predict the prognosis and survival in MBC patients.

The CellSearch(R) System is the first 510(k) diagnostic test used to automate
the capture and detection of CTCs, tumor cells that have detached from solid
tumors and entered the patient's blood.

"Measuring CTCs in metastatic breast cancer patients provides oncologists with
an additional tool to help us better monitor patient outcomes," said one of
the lead authors, Dr. Massimo Cristofanilli*, associate professor in the
Department of Breast Medical Oncology at The University of Texas M. D.
Anderson Cancer Center. "The CellSearch(R) CTC test provides an early
indication about patients' disease progression and overall survival."

CTCs and FDG-PET/CT are two of the most promising new tools for therapeutic
monitoring in patients with MBC. The number of CTCs identified in patients
with MBC is related to patient prognosis; a high number of CTCs at any time
during treatment is associated with poor prognosis.

"Veridex is committed to providing oncologists with high-value in vitro
diagnostic solutions, such as the CellSearch(R) CTC test, to help them make
informed patient care decisions," said Ken Berlin, general manager of Veridex.
"This study demonstrates the utility of integrating the CellSearch(R) CTC test
in therapeutic monitoring of patients with metastatic disease."

Study Design
A retrospective study was performed on 115 patients with MBC who had the
CellSearch test performed as part of their initial staging process at M.D.
Anderson over a three-year period. CTC count and FDG-PET/CT imaging were
performed at baseline in 102 evaluable patients before starting a new therapy
and then again at the midpoint of their therapies (9 - 12 weeks). Patients
outcomes were categorized according to midtherapy CTC counts as favorable (<
five CTCs/7.5 mL blood) or unfavorable (greater than or equal to five CTCs/7.5
mL blood). Based on FDG-PET/CT, patients were considered responders if
metabolic activity of target lesions decreased more than 25% compared to
baseline, and if there was no change or a decrease in size. Patients were
considered nonresponders if the FDG uptake was similar or higher and/or if
target lesions had increased in size. CTC counts and FDG-PET/CT response at
midtherapy were compared, and univariate and multivariate analyses were
performed to identify factors associated with survival.

Study Findings
A total of 115 patients with MBC were considered for the study and 102 were
evaluable for efficacy. The median overall survival time was 14 months (range,
1 to > 41 months). In univariate analysis, both midtherapy CTC counts and
FDG-PET/CT response predicted overall patient survival (p<.001 and p=.001,
respectively). The overall concordance between the CTC counts at midtherapy
and FDG-PET/CT was 67% for response/nonresponse and 74% for
progression/nonprogression. In the discordant category, detection of five or
more CTCs during therapeutic monitoring accurately predicted prognosis in MBC
beyond metabolic response. FDG-PET/CT was able to predict outcome in
discordant instances of patients with less than five CTCs at midtherapy.
Midtherapy CTC levels remained significant in a multivariate analysis
(p=.004). These results suggest a higher and independent predictive value of
CTCs compared with FDG-PET/CT among patients with a CTC count of five or more.
In addition, there was a strong correlation between complete response and the
absence of significant levels of CTCs (median CTC level zero).

* Dr. Cristofanilli is a principal investigator for a CellSearch(R) validation
study and received honoraria from Veridex, LLC.

About CellSearch(R)
The CellSearch(R) test works by using antibodies that are joined to
microscopic iron particles, called ferrofluid. These antibody/ferrofluid
combinations attach very specifically to CTCs. Powerful magnets then draw the
CTCs out of the blood sample and they are then stained with additional
bio-molecules and chemicals so that they can be positively identified as CTCs.

CellSearch(R) test results should be used in conjunction with all clinical
information derived from diagnostic tests (e.g., imaging, laboratory tests),
physical examination and complete medical history in accordance with
appropriate patient management procedures. For further information on intended
use, warnings and limitations, please refer to the CellSearch(R) CTC Test
Instructions for Use, or visit www.veridex.com.

About Veridex, LLC
Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to
providing physicians with high-value in vitro diagnostic oncology products.
Veridex's products may significantly benefit patients through earlier disease
detection and may enable personalized strategies to help improve patient
management and outcomes. For more information, visit www.veridex.com.

SOURCE Veridex, LLC

Media, Linda Davis, +1-908-218-8494, or Investors Louise Mehrotra,
+1-732-524-6491, or Stan Panasewicz, +1-732-524-2524, all for Veridex, LLC