Postoperative Adjuvant Therapy With Recombinant Interferon-Alpha Following Curative Resection of HCC
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
We conducted a randomized controlled trial of adjuvant interferon therapy in patients with
predominantly hepatitis B-related hepatocellular carcinoma (HCC) to investigate whether the
prognosis after hepatic resection could be improved. Since February 1999, patients with no
residual disease after hepatic resection for HCC were randomly assigned with stratification
by pTNM stage to receive no treatment (control group), interferon alpha-2b 10 MIU/m2 (IFN-I
group) or 30 MIU/m2 (IFN-II group) thrice weekly for 16 weeks. Enrollment to the IFN-II group
was terminated from January 2000 because adverse effects resulted in treatment
discontinuation in the first 6 patients. By June 2002, 40 patients each had been enrolled
into the control group and IFN-I group. The baseline clinical, laboratory and tumor
characteristics of both groups were comparable. The 1- and 5-year survival rates were 85% and
61%, respectively for the control group and 97% and 79%, respectively for the IFN-I group
(P=0.137). After adjusting for the confounding prognostic factors in a Cox model, the
relative risk of death for interferon treatment was 0.42 (95% CI 0.17 - 1.05; P=0.063).
Exploratory subset analysis showed that adjuvant interferon had no survival benefit for pTNM
stage I/II tumor (5-year survival 90% in both groups; P=0.917) but prevented early recurrence
and improved the 5-year survival of patients with stage III/IVA tumor from 24% to 68%
(P=0.038). In conclusion, in a group of patients with predominantly hepatitis B-related HCC,
adjuvant interferon therapy prevented early recurrence and improved survival in those with
pTNM stage III/IVA tumors.