FDA Clears Cellsearch™ Circulating Tumor Cell Test For Monitoring Metastatic Prostate Cancer Patients
Main Category: Prostate / Prostate CancerAlso Included In: Regulatory Affairs / Drug Approvals; Medical Devices / Diagnostics
Article Date: 29 Feb 2008 - 0:00 PDT
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Veridex, LLC announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic prostate cancer (MPC) patients. The CellSearch™ System currently is cleared for monitoring metastatic breast and metastatic colorectal cancer patients.
The CellSearch™ System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast, colorectal or prostate cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System provide additional information to the oncologist and does so earlier than other currently approved diagnostic modalities, thereby allowing the oncologist to make more-informed patient care decisions.
According to the American Cancer Society, prostate cancer claims approximately 27,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and grow. Currently, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch™ System helps physicians to predict disease progression and patient survival any time during therapy.
"I am extremely pleased that we now can offer this test to patients with metastatic prostate cancer," said Dr. Louis Fink of the Nevada Cancer Institute in Las Vegas, Nevada. "We have been evaluating the clinical utility of the CellSearch™ System in patients with metastatic prostate cancer since January 2007. Our findings demonstrate a strong indication that the baseline number of Circulating Tumor Cells (CTCs) is prognostic, and that the number of prostate CTCs is altered by the therapy." Dr. Nick Vogelzang, also of the Nevada Cancer Institute, continued, "We have compared CellSearch™ CTC test results to the standard clinical and biomedical parameters, such as prostate specific antigen (PSA) measured in MPC patients. A decrease in the number of CTCs is most often associated with patients successfully responding to therapy. Further analysis of CTCs may provide information as to the most efficacious treatments for specific individuals." These data will be presented at the 2008 American Association of Cancer Research (AACR) annual meeting in San Diego on April 12-16, 2008.
The CellSearch™ System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is a new class of diagnostic tools. The system's specificity, sensitivity and reproducibility allow for serial assessment of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner.
A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch™. The study, which took place in 65 clinical centers in the United States and Europe, involved 231 metastatic prostate cancer patients about to enter first- or later-line chemotherapy. Data showed that patients with less than five CTCs at baseline had significantly better survival rates versus patients with more than five CTCs. Data also showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC analysis and prostate specific antigen (PSA) assessment may provide the most accurate assessment of prognosis.
"Continued clinical studies validate the significance of circulating tumor cells, and now extend that significance to patients with metastatic prostate cancer," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are associated with shorter progression-free and overall survival rates."
The CellSearch™ 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 "pull" 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. The CellSearch™ test differs from the current standard of care because it can accurately predict prognosis much earlier than the prostate specific antigen serum tumor marker test.
In August 2004, a clinical study using the CellSearch™ test in metastatic breast cancer patients was published in The New England Journal of Medicine. The authors of this study concluded: "The very short median progression-free survival in patients with elevated circulating tumor cells at the first follow-up visit suggests that these patients are receiving ineffective therapy." In addition, as recently as November 2006, a metastatic breast cancer study was published in Clinical Cancer Research where the authors concluded: "The results reported here indicate that the evaluation of CTCs is an accurate measure of treatment efficacy." Additionally, the authors said: "The ability to serially quantitate and interrogate CTCs in patients with breast cancer makes possible new ways of managing and investigating the disease."
Dr. N. Vogelzang is the recipient of a research fellowship grant from Veridex for the purpose of supporting independent research in metastatic prostate cancer patients.
About Veridex
Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. For additional information, please visit http://www.veridex.com.
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FDA Clears Cellsearch Circulating Tumor Cell Test For Monitoring Metastatic Prostate Cancer Patients
posted by Gregory D. Pawelski on 29 Feb 2008 at 5:52 pmResults of using the CellSearch System indicate that monitoring of circulating tumor cells (CTC's) can contribute to the understanding of tumor-blood interactions and may provide a valuable tool for therapy monitoring in solid tumors like breast, colorectal or prostate cancer. With cells being alive in circulation, it may mean that a patient would need additional treatment.
These ciculating tumor cells can detach from solid tumors and enter the blood stream, thus beginning the process of metastasis, the most life-threatening aspect of cancer. To metastasize, or spread cancer to other sites in the body, circulating tumor cells travel through the blood and can take root in another tissue or organ (like the lungs, bones, liver, adrenals and even the brain).
Immunicon's founder/scientist (immunologist) Paul Liberti's Immunicon team developed all the technology to help researchers and oncologists monitor CTC's. Immunicon licensed their technology to Johnson & Johnson who formed a new unit called Veridex to market Immunicon's CellSearch technology. The technology gives the patient and oncology community a great method to monitor treatment.
The CellSearch system can be very complimentary to an array of tools that oncologists should be using to counsel their patients. The only problem with this method is that the patient may receive potentially toxic and ineffective drugs before circulating tumor cells are measured. The CellSearch System could be utilized for confirmation after being administered the assay-directed most beneficial therapeutic agents.
The CellSearch technique can be done earlier than other currently approved diagnostic modalities like CT, MRI or PET imaging. However, you are measuring the drug effects on tumors "in" the patient, one treatment at a time. The outcome for metabolic responders and non-responders with imaging and the CellSearch System is basically what is going on with a "functional" profiling assay, showing what patients are benefiting from what drug agents, "before" introducing them into the patient.
Anti-cancer treatments often effectively shrink the size of tumors, but some might have an opposite effect, actually expanding the small population of cancer stem cells believed to drive the disease. Some treatments could be producing more cancer stem cells which are then capable of metastasizing, because these cells are trying to find a way to survive the therapy. The tumor escapes from chemotherapy by induction of stem cell marker expression. The small number of cells that survive the treatment could then generate another tumor that metastasizes.
This may help explain why the expression of stem cell markers has been associated with resistance to chemotherapy and radiation treatments and poor outcome for patients with cancers including prostate, breast and lung cancers. That tells us that understanding how to target these markers and these cells could prove useful in treating these cancers.
Analysis of stem cell expression before and after treatment reveals that even as some anti-cancer treatments shrank tumors, they increased expression of stem cell markers like Nanog and BMI1 (both of which contibute to stem cells' defining ability to renew themselves and differentiate into different cell types). Some treatments are not enough to completely inhibit tumor growth, and the cancer stem cell markers are still present.
Even if one or more chemotherapy regimen is identified as being likely to work on a particular cancer, has the science advanced to tell us whether application of the chosen chemotherapy regimen will not cause other changes that also cause cancer to later return and perhaps be even harder to treat? Is it a case of chemotherapy being bad, in cases where it apparently works? Chemotherapy can be mutagenic (changes in form). It might kill off a whole lot of cancer, only to cause a mutation in the remaining cancer, such that the remaining cancer behaves in a more aggressive fashion.
Much more work needs to be done, and oncologists need to adapt treatment to the patient. There are hundreds of chemotherapeutic agents, all of which have approximately the same probability of working. The tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing individual properties of each patient's cancer.
An Alternative
posted by Diane on 14 Mar 2011 at 8:08 amIt is encouraging that patients with advanced metastatic breast cancer have another tool in their arsensal to evaluate the effectiveness of treatment and, when combined with other information, help them and their oncologists make more informed treatment.
According to my oncologist, the results of the CTC offer physicians the ability to detect changes up to one year before other modalities may detect them, such as MRIs. When even a few weeks may impact the patient's life span, having such information has clear advantages, including those related to treatment and to quality of life.
The CTC has other benefits, as well. It does not invlove radiation exposure, which is cumulative over the patient's life span. Further, it requires a minimal time commitment (i.e., having a blood test), thus allowing the patient to return quickly to "normal" activities without having ao fast, drink "yucky" contrasts, or devot hours to other forms of testing ... and, sometimes, without having to deal with a machine that breaks down during the middle of a scan! It costs less than scans, such as MRIs, PETs, CTs, etc.
I must emphasize I am not advocating relying only on CTC results to assist patients and their physicians evaluate disease progression and treatment efficacy. The CTC is one very promising tool in the diagnostic/treatment repertoire of physicians whose goal is to provide the best diagnostic and treatment armementarium to patients. Ultimately, finding a cure is the desired goal. Until then, offering patients the best possible treatment based on the most effective tools is the goal. Doing so will increase quality of life and life span!
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