Navigation Links
Monitoring Circulating Tumor Cells With the CellSearch(R) System Can Predict Prognosis in Metastatic Breast Cancer
Date:7/13/2009

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 Journal of 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
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiogaphic Data Safety Monitoring Board Review
2. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiographic Data Safety Monitoring Board Review
3. Boston Scientific Releases Remote Monitoring Data from its Wireless LATITUDE(R) Patient Management System
4. Masimo Launches Patient SafetyNet and Showcases the Rainbow SET Upgradable Noninvasive Monitoring Platform at 2007 ASA Annual Meeting
5. Oridion Launches its Fully Integrated Remote Monitoring System and SARA Software for Improved Patient Safety
6. BioMS Medicals relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
7. BioMS Medicals phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
8. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R)
9. BioMS Medicals pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board
10. DermTech Is Issued U.S. Patent for the Early Detection, Staging and Monitoring of Melanoma
11. CleveMed Receives $1.5 Million in NIH Funding to Further Develop a Portable System for Monitoring Parkinsons Disease Motor Symptoms
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... ... 05, 2016 , ... This composition patent, U.S. Patent No. ... The composition claims are not limited to any particular process to make or ... carbon fibers, graphene, and other materials. A continuation application, U.S. Patent App. ...
(Date:12/5/2016)... , Dec. 5, 2016  Renova™ Therapeutics, ... congestive heart failure and other chronic diseases, announced ... the company as Chief Financial Officer (CFO), effective ... with 20 years of experience in financial management ... biotech and software companies. Most recently, Ms. Bovenizer ...
(Date:12/5/2016)... , December 5, 2016 The ... with almost $108 billion of revenue and some $890 ... were spent on global biopharmaceuticals, and this figure is ... Stock-Callers.com has lined up these four equities for assessment: ... Pharmaceuticals Inc. (NASDAQ: ACAD ), Acorda Therapeutics ...
(Date:12/2/2016)... ... ... In anticipation of AxioMed’s exclusive cleanroom manufacturing facility in ... Lubinski will be traveling to Switzerland from December 5-10. Mr. Lubinski will meet ... to discuss the benefits of a viscoelastic disc. AxioMed received CE mark in ...
Breaking Biology Technology:
(Date:11/30/2016)... SAN FRANCISCO and WARSAW, Poland , Nov. 30, 2016 ... sleeping. It is one of the most crucial aspects of recovery so we need ... host of serious health risks, including heart problems, high blood pressure, stroke, diabetes, and ... family and friends sleep and find a Christmas present that could help them to ... ...
(Date:11/29/2016)... Lithuania , Nov. 29, 2016 /PRNewswire/ ... biometric identification and object recognition technologies, today ... (SDK) for fingerprint recognition solutions that run ... a fingerprint template using less than 128KB ... in compact devices that have limited on-board ...
(Date:11/24/2016)... Cercacor today introduced Ember TM Sport ... non-invasively measure hemoglobin, Oxygen Content, Oxygen Saturation, Perfusion ... in approximately 30 seconds. Smaller than a smartphone, using ... to key data about their bodies to help monitor ... Hemoglobin carries oxygen to muscles. When hemoglobin ...
Breaking Biology News(10 mins):