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Title: Survival Unaffected by Interferon Alpha-2b after Surgical Resection for Liver Cancer: Presented at AASLD

"Survival Unaffected by Interferon Alpha-2b after Surgical Resection for Liver Cancer: Presented at AASLD"

By Crystal Phend SAN FRANCISCO, CA -- November 15, 2005 -- Interferon alpha-2b may not improve recurrence-free survival or overall survival after surgical resection of hepatocellular carcinoma in patients with hepatitis B or C infection. The findings were presented here at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Hepatocellular carcinoma from hepatitis C virus-related liver damage is frequently treated with surgical resection in Asian countries. Surgical resection has the advantage of not requiring immune suppression, whereas liver transplantation has the advantage of treating the underlying cirrhosis from hepatitis infection. Surgical resection is equivalent to transplantation, said lead author Li-Tzong Chen, MD, PhD, Associate Investigator and Attending Physician, National Cancer Research Center, Taipei, Taiwan. Although interferon is used routinely after transplantation to fight the tumor and infection, its role after surgical resection is unclear, he said during his presentation on November 14[^th.

In the study, 264 patients who underwent curative resection for virus-related hepatocellular carcinoma were randomized to receive treatment with interferon alpha-2b or observation alone.

The interferon regimen was started at a dose of 1 million International Units (MIU) for week 1 and escalating to 5 MIU five times a week to week 5, then three times a week for 48 weeks.

Study patients had no radiographic evidence of vascular involvement and good resection margins. Patient characteristics were similar between groups, including cirrhosis in about 55% of both, with the exception of hepatitis viral activity that was significantly higher in the control group.

Disease recurrence and death rates were similar in the two groups.

The overall survival rate changed dramatically during the study to become statistically significant in favor of interferon alpha-2b. At 24 weeks, overall survival was 84.2% in the treatment group compared to 66.7% in the observation group. By week 60 of follow-up, overall survival in the interferon group was 62.3% and in the observation group it had decreased to 25.1%.

The 5-year survival rate for the interferon group was equivalent to that achieved with liver transplantation, Dr. Chen said.

Patients with virological response had significantly better recurrence-free survival. However, interferon alpha-2b did not improve recurrence-free survival. At 6 years, it was similar across the treatment groups but numerically higher in the observation group: 45.6% vs. 42.3%.

Interferon alpha-2b was generally well tolerated, Dr. Chen said.

He concluded that a larger adjuvant trial should be conducted with a more effective anti-hepatitis agent.

[Presentation Title: Randomized Phase III Study of Adjuvant Interferon Alpha-2b in Hepatocellular Carcinoma With Curative Resection -- The Taiwan Cooperative Oncology Group (TCOG T1297) Study. Abstract 102]

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