Drug & Device Development

Combination therapy useful for advanced hepatoma

Last Updated: 2011-12-29 18:46:19 -0400 (Reuters Health)

By Will Boggs MD

NEW YORK (Reuters Health) - Japanese researchers say patients with hepatocellular carcinoma (HCC) that's invaded the portal vein might have better outcomes if they receive intra-arterial 5-fluorouracil (5-FU) plus systemic pegylated interferon alpha-2b.

Patients with HCC and portal vein tumor thrombosis (PVTT) do poorly even with sorafenib (Nexavar), an oral kinase inhibitor approved for unresectable liver cancer, the investigators note in a November 9th paper online in Cancer.

"The outcome in our study was far superior to the sorafenib study," Dr. Kazuhiro Kasai from Iwate Medical University told Reuters Health by email. Dr. Kasai added that another recent study has also found hepatic arterial infusion chemotherapy (HAIC) to be superior to sorafenib for HCC patients with PVTT.

Dr. Kasai and colleagues report on 59 patients treated with 5-FU HAIC and subcutaneous pegylated interferon alpha-2b.

After the first course of therapy, 73% of patients had responded in some manner: two (3.5%) had a complete response, 41 (69.5%) had a partial response, 11 (18.6%) had stable disease, and five (8.4%) had progressive disease.

The median length of progression-free survival was 9.7 months. Cumulative progression-free survival rates were 67.4% at six months, 30.2% at 12 months, 25.9% at 18 months, and 20.7% at 24 months.

Overall, patients survived for a median of 29.9 months. Cumulative survival rates were 82.4% at six months, 73.6% at 12 months, 52.8% at 24 months, and 44.0% at 36 months.

Among patients who did not receive additional therapies (such as surgery or radiofrequency ablation), the median progression-free survival was 7.6 months and the median overall survival was 29.2 months.

In a multivariate analysis, the achievement of complete or partial remission was the only independent predictor of survival.

There were no treatment-related deaths or discontinuations, and there were no grade 4 treatment-related adverse effects. All less severe adverse reactions were controllable by medical treatment and/or temporary suspension of HAIC, according to the authors.

"Based on our findings and other study findings, treatment by HAIC for patients (with) HCC with PVTT is likely to be useful," Dr. Kasai concluded, "although a large-scale randomized controlled study in comparison with sorafenib is needed to properly evaluate the efficacy of this therapy."

HCC is the third leading cause of cancer death worldwide, causing around half a million deaths annually. "About 10-20% (40-80 patients/year) of HCC patients in our hospital have HCC with PVTT," Dr. Kasai said.

SOURCE: http://bit.ly/tvKziZ

Cancer 2011.