EMBARGOED FOR RELEASE UNTIL: April 8, 2002

Contact: Karen E. Warmkessel, [email protected]

Ellen Beth Levitt, [email protected].(410) 328-8919

OUTPATIENT THERASPHERE PROCEDURE EXTENDS LIVES OF PATIENTS WITH INOPERABLE LIVER CANCER

Findings will be reported this week at national medical meetings in Baltimore and San Francisco by University of Maryland Greenebaum Cancer Center specialists

A non-surgical outpatient procedure called TheraSphere that uses millions of microscopic glass beads imbedded with radiation to treat inoperable liver cancer is adding months to patients' lives, specialists at the University of Maryland Greenebaum Cancer Center report.

Normally, patients diagnosed with primary liver cancer live an average of four months without surgery. But, the 16 primary liver cancer patients treated with TheraSphere have survived an average of eight months, according to Ravi Murthy, M.D., an interventional radiologist at the Greenebaum Cancer Center and a member of a team of doctors that treats TheraSphere patients. "We expect that more than 40 percent of the patients will still be alive a year after treatment," he says.

The one-year survival rate for 43 other patients whose cancer started in the colon is even higher, at 50 percent, with an average survival of 10 months, Dr. Murthy said. Such patients, who have not responded well to multiple chemotherapies, generally live three to six months at that advanced stage of their disease.

"Our patients treated with TheraSphere are living longer and their quality of life is better than with other treatments, such as chemotherapy, chemoembolization or external beam radiation," says Dr. Murthy, who is also an assistant professor of diagnostic radiology and medicine at the University of Maryland School of Medicine. "It's a promising treatment that needs to be studied further."

He will present the findings at the 27th annual meeting of the Society of Cardiovascular and Interventional Radiology to be held April 6-11 in Baltimore. His University of Maryland colleagues, Andrew S. Kennedy, M.D., a radiation oncologist, and David A. Van Echo, M.D., a medical oncologist, will also report the results at the 93rd annual meeting of the American Association for Cancer Research to be held April 6-10 in San Francisco.

"Our studies include the largest number of patients treated with this state-of-the-art radiation therapy ever reported," says Dr. Kennedy, who is also an assistant professor of radiation oncology at the University of Maryland School of Medicine. He is particularly encouraged by the data involving colorectal cancer patients, all of whom failed several different chemotherapy regimens before being treated with TheraSphere.

Dr. Van Echo, the director of the new drug development program at the Greenebaum Cancer Center and a professor of medicine at the University of Maryland School of Medicine, says, "We think this method of delivering radiation to the liver is going to become increasingly more common as the type of treatment used for patients with liver malignancies."

In August 2000, the University of Maryland Greenebaum Cancer Center was the first institution in the country to successfully develop and perform the procedure as an outpatient therapy.

TheraSphere delivers millions of microscopic glass beads imbedded with the radioactive element yttrium-90 directly into the blood vessels of the tumors. The beads -- which are one-third the diameter of a human hair -- are carried through a catheter placed in the femoral artery in the thigh and then guided into the hepatic artery, the main blood vessel in the liver. They remain in the body and lose their radiation within two weeks.

Patients can return home the same day, and there is no risk to family members. Possible side effects include vomiting, mild fever, abdominal pain and gastric ulcers, but so far, the main complaints have been fatigue and nausea.

"You can live a normal life. You don't have to be hospitalized and you don't have to be shielded. You can get hugs from your spouse and play with your kids," Dr. Van Echo said.

The treatment, which spares healthy tissue while providing radiation directly to the tumors, was approved by the Food and Drug Administration in March 2000 for treatment of liver cancer that cannot be removed surgically. The manufacturer, MDS Nordion, was granted a humanitarian device exemption to market the treatment based on proof that it is safe for patients.

So far, 93 patients have been treated with TheraSphere at the Greenebaum Cancer Center in Baltimore. Sixteen had primary liver cancer, 43 had metastatic colon cancer, 14 had neuroendrocrine cancers and the remainder had cancers that spread from other areas of the body such as the breast and lung.

Initially, the doctors treated the entire liver, but later discovered that patients tolerated the procedure better as a two-part process in which the right lobe of the liver was treated first and the left lobe was treated two to four weeks later.

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