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.