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Data Show Preoperative Assessment of Breast Cancer Patients Enables Early Diagnosis, Successful Treatment of Lymphedema
Date:4/30/2008

National Institutes of Health, National Naval Medical Center, George Mason University Study Published in Journal Cancer Demonstrates Importance of Physicians' Shift to Baseline Measures and Ongoing 'Surveillance' Model for

Successful Management of Common, Debilitating Condition

BETHESDA, Md., April 30 /PRNewswire/ -- The preoperative assessment of breast cancer patients for subclinical lymphedema enables clinicians to establish a baseline, which serves to enable the early diagnosis and successful treatment of the debilitating condition, according to data from a five-year study published this week in the online edition of the journal Cancer (http://www3.interscience.wiley.com/cgi-bin/abstract/118821880/ABSTRACT).

In a study conducted by the National Institutes of Health (NIH) and the National Naval Medical Center, in collaboration with faculty and students from the University of Michigan-Flint and George Mason University, researchers measured the upper limb volume of 196 newly diagnosed breast cancer patients from 2001 to 2006 to establish a baseline prior to surgery. At designated postoperative intervals, the researchers took repeated measurements as part of a "surveillance" model to monitor for possible impairments related to breast cancer treatment--such as lymphedema--as opposed to treating therapy-related problems after they occur. Using the surveillance approach, the investigators demonstrated that a short trial of compression garments effectively treated subclinical lymphedema when it was detected early. Forty-three, or 22 percent, of the 196 breast cancer patients in the study developed subclinical lymphedema, as defined by a change in limb volume of >75cc; and all subjects showed a significant mean volume reduction to very near their pre-surgical "normal" state. All subjects were able to maintain this level for an average of 4.8 months, and none of the patients demonstrated progression of the condition in the follow-up period.

Steven Schonholz, M.D., a breast surgeon and medical director of the Breast Cancer Center at Mercy Medical Center in Springfield, Mass., added: "The problem with lymphedema is that there hasn't been an easy way to detect the condition before it is apparent to the doctor and patient. Today there are new, non-invasive methods that have enabled me to identify the condition and begin treatment long before the patient is aware of a problem. If patients aren't treated at the earliest possible indication of lymphedema, it is less likely to be effectively treated, and the condition may require life-long costly treatment and, more importantly, have an enormous impact on a woman's self-esteem, function and quality of life."

While there is no standard tool used to assess the condition, physicians have relied on tape measures and water displacement to track changes in limb circumference and size as well as on patients to report changes in upper extremity mobility. Several diagnostic tools are able to accurately track minute changes in extracellular fluid to allow for the earliest possible detection. These include bioimpedance spectroscopy devices, which use an electrical signal to assess fluid changes in the body.

"Optimal management of lymphedema requires diagnostic tools that are sensitive to subclinical changes in tissue," said Dr. Schonholz, who uses an FDA-cleared low frequency bioimpedance device developed by ImpediMed Inc. in his practice.

About Lymphedema

Lymphedema is a condition that can cause significant swelling of the upper and lower extremities due to the build-up of excess lymph fluid. This can occur when the lymphatic system, which is responsible for draining excess fluid from the body and is a key component of the immune system, is damaged or altered. In breast cancer patients, this can occur after surgery, such as removal or biopsy of the lymph nodes, and/or radiation therapy. It is estimated that 6 percent to 40 percent of patients with breast cancer develop lymphedema, and that it often occurs within the first two years after surgery.

For some cancer survivors and others at risk, a low level lymphedema can occur 10 years to 15 years following the initial primary treatment and develop into a condition that has a serious impact on overall health and quality of life. For more information about lymphedema, visit http://www.nci.nih.gov/cancerinfo/pdq/supportivecare/lymphedema/patient/.

Contacts: Wendy Lau or David Schull

Russo Partners LLC

(212) 845-4272

wendy.lau@russopartnersllc.com

david.schull@russopartnersllc.com


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SOURCE ImpediMed Inc.
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