NEW ORLEANS, LA -- April 6, 2005 -- Transcatheter arterial chemoembolization (TACE) is a safe procedure with minimal toxicity in patients with inoperable liver cancer, according to findings presented here April 4^th at the 30^th annual meeting of the Society of Interventional Radiology.

Because of its safety profile, TACE should be a first-line therapy for patients with this disease, said senior investigator Jeff Geschwind, MD, associate professor of radiology, surgery, and oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.

Dr. Geschwind stressed that TACE does not effect a cure, but rather prolongs life. As a locoregional therapy, it exposes patients to lower doses of chemotherapy and therefore enhances their quality of life, he said. He also stressed that TACE fills a void in treatment options for liver cancer.

"The treatment of choice is surgical resection or transplantation, but only 10% to 15% of patients are eligible for surgery," he said. "The mortality for these surgeries is 4% to 12%, and the recurrence rate is 85% in the remnant liver. Similarly, systemic chemotherapy is ineffective and linked to poor quality of life."

Because it is difficult to get a high enough dose delivered to the tumor, TACE is also costly and linked to high rates of toxicity, he said.

The approach consists of chemotherapy guided through imaging so that the emulsion can be delivered directly to the tumor. However, Dr. Geschwind cautioned that treatment does not result in tumor shrinkage; therefore, TACE cannot be considered curative.

The investigators conducted their study to address the paucity of data regarding comprehensive post-TACE toxicity. They assessed the incidence of toxicity in people with liver cancer who had been treated with TACE. The investigative team used the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3 (CTCAE v.3) as a way to express the data.

The team retrospectively analyzed data from 149 patients who underwent 436 TACE procedures between 1998 and 2003. The patients were 13 to 85 years old; 76% were men. In this cohort, 58% had hepatic cellular carcinoma; 23% had neuroendocrine metastases; the remaining 19% had other liver metastases. By functional status, 82% were classified as Class A; 17% were Class B; and 1% was Class C.

Patients underwent treatment that consisted of an emulsion of ethiodol oil and a chemotherapy cocktail that included cisplatin, doxorubicin hydrochloride, and mitomycin C, followed by 300 to 500 micron embospheres.

When the investigators assessed toxicity, the events that had been recorded included the following: electrolyte imbalances; toxicity to kidneys and liver; clotting abnormalities; and anemia, leukopenia, and thrombocytopenia. They were also able to analyze the rates of hyper- and hypoglycemia, nausea and vomiting, and abdominal pain, as well as alopecia and fatigue.

The investigators identified adverse events based on laboratory values scored according to CTCAE v.3 guidelines, except for alopecia, nausea, vomiting, and abdominal pain.

More than 75% of patients had no toxicity, Dr. Geschwind said. The most severe and frequent relative toxicities, occurring at Grades 3 and 4, levels were as follows; elevated aspartate amino transaminase occurred at a Grade 3 level in 6.7% and at Grade 4 in 2.7%; Grade 3 and 4 elevated amino alanine transaminase elevations occurred in 6.7% and 1.3% of patients, respectively.

Patients developed Grade 3 and 4 leukopenia at rates of 2% and 7.4%, respectively, and bilirubin elevation of this severity occurred in 6% in each of these grades, respectively. In patients developing anemia, 2.7% had Grade 3 and none had Grade 4 anemia. Hyperglycemia occurred at these levels in 4.7% and 3.4%, respectively, and hyperkalemia Grades 3 and 4 was present in 4% and 2.7% of patients, respectively. In patients who developed hypoalbuminemia, 2.7% had Grade 3, and none had Grade 4. Creatinine elevation was present in 2.7% at Grade 3 and none at Grade 4.

The findings show that TACE is well tolerated and, considering its benefits, has an acceptable profile as a minimally invasive procedure for patients with unresectable liver cancer, Dr. Geschwind said.

In a press conference, he said that, in addition to primary hepatic tumors, investigators are also interested in the feasibility of using TACE as a treatment for colorectal and breast metastases to the liver.