Drug & Device Development

Sorafenib can be combined with arterial embolization for treating liver tumors

Last Updated: 2012-12-06 11:41:14 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Sorafenib given concurrently with transarterial chemoembolization (TACE) is safe in patients with intermediate hepatocellular carcinoma (HCC) and does not lead to any unexpected adverse effects, according to the results of a phase II trial conducted in South Korea, China, and Taiwan.

"In addition to encouraging safety and tolerability results, our study also reveals promising efficacy results with almost 50% of patients achieving partial or complete responses after the first TACE cycle and almost 50% achieving a partial response or stable disease up to two years after the first TACE cycle," the researchers reported in the International Journal of Cancer online November 29.

Dr. Yee Chao, with National Yang-Ming University, Taipei, and colleagues explain that TACE, which concentrates chemotherapeutic agents at the tumor site while blocking the artery feeding the tumor, has become a "cornerstone" of treatment of HCC in Asia, while sorafenib monotherapy has been shown to prolong survival in advanced HCC patients.

The team investigated the safety and efficacy of combining the two treatments in an open label trial involving 165 patients with intermediate HCC, of whom 147 were included in an intention-to-treat analysis.

TACE was performed with an emulsion of lipiodol and doxorubicin followed by gel-foam embolization, and sorafenib was given four to seven days later. The treatment was repeated every six to eight weeks, with a mean of 2.1 cycles administered in the study population.

Gastrointestinal and skin adverse events were reported by 62.6% and 57.8% of patients, respectively, but most were mild to moderate, according to the report. "Importantly, these were not unexpected side effects, and combination therapy did not appear to lead to worse AEs than observed with either TACE or sorafenib therapy alone," the authors point out.

As mentioned, response rates were about 50%, and time to disease progression was 280 days, which compares favorably to some other recent studies.

Summing up, Dr. Chao and colleagues conclude, "The results indicate that the combination is safe, efficacious and provides tangible benefits in terms of response to disease and time to progression."

Meanwhile they add, ongoing trials are investigating sorafenib versus placebo in combination with TACE for intermediate stage HCC, and TACE combined with dose reductions of sorafenib to evaluate potential improvements in safety and toxicity.

"It is hoped," they write, "that these ongoing trials will contribute to the determination of optimal therapy combinations and timing which will be crucial in improving outcomes with intermediate HCC."

SOURCE: http://bit.ly/VpfU19

Int J Cancer 2012.