EMBARGOED FOR RELEASE UNTIL NOV. 28, 2001 12:00 ET
Contact: Gwen Fariss Newman ([email protected])
Ellen Beth Levitt ([email protected])410-328-8919
UNIVERSITY OF MARYLAND REPORTS IMPROVED SUCCESS RATE AFTER MODIFYING THERASPHERE TREATMENT FOR INOPERABLE LIVER CANCERFindings reported at 87th Radiological Society of North America conference
Cancer specialists at the University of Maryland Greenebaum Cancer Center (GCC) report that TheraSphere, a new approach used to treat inoperable liver cancer, has resulted in a 38 percent success rate as marked by a reduction in tumor size and/or number of lesions. Side effects also have been minimized by modifying the procedure, according to Andrew Kennedy, M.D., who will report these findings at the 87th Scientific Assembly and Annual Meeting of the Radiological Society of North America, to be held Nov. 25-30 in Chicago, IL.
In October 2000, the Greenebaum Cancer Center in Baltimore was the first institution in the country to successfully develop and perform the TheraSphere procedure as an outpatient therapy. It remains the primary site in North America for treating patients, other than those with primary liver cancer, with TheraSphere. GCC physicians are currently training physicians at other cancer centers nationwide to perform TheraSphere.
Patients with colorectal or gastrointestinal tumors including carcinoid tumors have shown the most dramatic improvements, while patients with larger liver tumors from the pancreas and bile ducts have been least responsive. More than 70 patients have undergone the procedure at the University of Maryland Greenebaum Cancer Center. All had been previously treated unsuccessfully with multiple courses of chemotherapy, chemoembolization and/or radio frequency ablation.
"The results have been promising since its introduction last fall and the success rate for TheraSphere continues to improve," says Dr. Kennedy, a radiation oncologist at the University of Maryland Greenebaum Cancer Center and an assistant professor of radiation oncology at the University of Maryland School of Medicine. "Interestingly, minimal side effects such as fatigue and nausea have been reduced further by incorporating some minor changes in the administration of the treatment."
TheraSphere is a targeted therapy in which millions of microscropic glass beads containing yttrium 90, a radioactive element, are delivered via catheter into the femoral and hepatic arteries and transported directly to the liver. The University of Maryland Greenebaum Cancer Center uses CT scans of the liver to produce a three-dimensional view of the tumors to more precisely target the diseased cancer cells themselves.
The team also has modified its treatment approach to produce less toxicity. Initially, patients were treated with infusion throughout the whole liver. Subsequently, the physicians treated the right lobe only followed several weeks later with a TheraSphere infusion to the left lobe.
"Whole liver infusion was associated with greater side effects compared to the sequential treatment approach," explains Dr. Kennedy. "Generalized fatigue was more common in the group that had a whole liver infusion (88 percent compared to less than one-third -- 30 percent -- of those treated in two separate doses). Also, episodes of nausea were more common in the whole liver treatment group (34 percent compared to 10 percent)."
"We're delivering the same amount of treatment using the sequential approach," says Dr. Kennedy. "But by splitting the dose, we're exposing the surrounding tissue to less radiation and decreasing the chance of the patient developing gastrointestinal toxicities. In fact, the statistics are showing that fatigue and nausea, the most common side effects, were almost three times more common in those treated with one dose versus those whose treatment was split into two."
TheraSphere was approved by the U.S. Food and Drug Administration (FDA) last March for liver cancer that cannot be treated surgically. The FDA granted MDS Nordion, which makes TheraSphere, a Humanitarian Device Exemption based on proof of patient safety alone. This exemption also encourages further research and development for diseases that affect few patients.
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.
"Though fewer than 10,000 Americans are diagnosed with liver cancer each year, it is a rapidly fatal disease with few treatment options," explains Dr. Kennedy. "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 with the hepatitis B or C virus."
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