May 2001

From University of Maryland Medical Center

UM physicians report promising results for TheraSphere, new treatment option for inoperable liver cancer

Cancer specialists from the University of Maryland Greenebaum Cancer Center report that early results of a new treatment for inoperable liver cancer, known as TheraSphere, are promising. They will report their findings at the 37th annual meeting of the American Society of Clinical Oncologists on May 15. The Greenebaum Cancer Center in Baltimore is the first in the nation to successfully perform the procedure.

Forty-five patients have undergone the procedure there since its introduction last fall, according to David Van Echo, M.D., professor of medicine at the University of Maryland School of Medicine and director of the New Drug Development Program at the Greenebaum Cancer Center. “Most patients have shown a positive response, as marked by a reduction in tumor size or number of lesions, with minimal side effects,” says Dr. Van Echo.

“TheraSphere is a unique new targeted therapy that spares healthy tissue while providing radiation directly to liver tumors,” says Dr. Van Echo. “Millions of microscopic glass beads containing the radioactive element, yttrium 90, are delivered via catheter into the femoral and hepatic arteries and transported directly to the liver. This mechanism allows a more concentrated dose precisely where it’s needed most. Preliminary results have been very promising.”

The most dramatic improvements have been noted in patients with gastrointestinal carcinoid tumors --those that develop in certain hormone-making cells – also called neuroendocrine cells -- of the digestive system. “Extremely interesting is the fact that of three neuroendocrine patients treated with TheraSphere, all had tumors that completely disappeared,” says Dr. Van Echo.

Also showing favorable response to TheraSphere are patients with colorectal tumors. “Of seven patients in this category, two have died of progressive cancer outside the liver, but the other five are doing well six months after treatment,” says Dr. Van Echo. “They had not been helped by conventional chemotherapy and the average length of survival with this particular diagnosis is three to six months. With TheraSphere treatment, they’re all healthy, living longer and enjoying a higher quality of life.”

TheraSphere was approved by the U.S. Food and Drug Administration (FDA) last March for the treatment of liver cancer that cannot be treated surgically. The FDA granted MDS Nordion, which makes TheraSphere, a Humanitarian Device Exemption. This exemption, which permits the FDA to approve devices based on proof of patient safety alone, encourages further research and development for diseases that affect few patients.

“Our experience thus far indicates that the procedure does have benefit for the patient and we have a better understanding of who’s most likely to benefit,” says Dr. Van Echo. Those less responsive to TheraSphere as a treatment option are patients who have larger liver tumors, for example.

TheraSphere is a non-surgical outpatient procedure. Patients can return home the same day and treatment poses no safety threat to caregivers or family members. Side effects can include vomiting, mild fever, abdominal pain and gastric ulcers. Toxicities are evident in about 20 percent of patients treated.

And though patients initially were treated with a single dose, the procedure is being evaluated as a two-part process in which the right lobe of the liver is treated and the left lobe is treated two to four weeks later.

“We’re delivering the same amount of treatment using the sequential approach,” says Dr. Van Echo. “But by splitting the dose, we’re exposing the surrounding tissue to less radiation and decreasing the chance of then patient developing gastrointestinal toxicities.”

The University of Maryland Greenebaum Cancer Center remains the only institution nationwide treating patients, other than those with primary liver cancer, with TheraSphere.

“Though fewer than 10,000 Americans are diagnosed with liver cancer each year, it is a rapidly fatal disease with few treatment options,” says Dr. Van Echo. “Surgery remains the preferred treatment, but fewer than 15 percent of patients qualify for that option due to the advanced progression of the disease. And, though liver cancer is more prevalent in other countries such as Africa and Asia, it is on the rise in the United States due to the increasing number of persons who have the Hepatitis B or C virus.”

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