A randomized, controlled trial of postoperative adjuvant interferon therapy after resection of hepatocellular carcinoma

被引:202
作者
Lo, Chung Mau
Liu, Chi Leung
Chan, See Ching
Lam, Chi Ming
Poon, Ronnie T. P.
Ng, Irene O. L.
Fan, Sheung Tat
Wong, John
机构
[1] Univ Hong Kong, Ctr Study Liver Dis, Hong Kong, Hong Kong, Peoples R China
[2] Univ Hong Kong, Dept Surg, Hong Kong, Hong Kong, Peoples R China
[3] Univ Hong Kong, Dept Pathol, Hong Kong, Hong Kong, Peoples R China
关键词
D O I
10.1097/01.sla.0000245829.00977.45
中图分类号
R61 [外科手术学];
学科分类号
摘要
Objective: 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. Summary Background Data: Recurrence is common after hepatic resection for HCC. Interferon possesses antiviral, immunomodulatory, antiproliferative, and antiangiogenic effects and may be an effective form of adjuvant therapy. Patients and Methods: 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/m(2) (IFN-I group) or 30 MIU/m(2) (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. Results: 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% Cl, 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). Conclusion: In a group of patients with predominantly hepatitis B-related HCC, adjuvant interferon therapy showed a trend for survival benefit, primarily in those with pTNM stage III/IVA tumors. Further larger randomized trials stratified for stage are needed.
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页码:831 / 842
页数:12
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