Long-Term Results of a Randomized, Observation-Controlled, Phase III Trial of Adjuvant Interferon Alfa-2b in Hepatocellular Carcinoma After Curative Resection

被引：172

作者：

Chen, Li-Tzong ^{[1
,2
,3
]}

Chen, Miin-Fu ^{[4
,5
]}

Li, Lung-An ^{[6
,7
]}

Lee, Po-Huang ^{[12
]}

Jeng, Long-Bin ^{[8
]}

Lin, Deng-Yn ^{[5
,9
]}

Wu, Cheng-Chung ^{[10
]}

Mok, King-Tong ^{[11
]}

Chen, Chao-Long ^{[12
]}

Lee, Wei-Chen ^{[4
,5
]}

Chau, Gar-Yang ^{[13
]}

Chen, Yaw-Sen ^{[12
]}

Lui, Wing-Yui ^{[10
]}

Hsiao, Chin-Fu ^{[6
]}

Whang-Peng, Jacqueline ^{[1
,16
]}

Chen, Pei-Jer ^{[14
,15
]}

机构：

[1] Natl Hlth Res Inst, Natl Inst Canc Res, Tainan 704, Taiwan

[2] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Dept Internal Med, Kaohsiung, Taiwan

[3] Natl Cheng Kung Univ Hosp, Dept Internal Med, Tainan 70428, Taiwan

[4] Chang Gung Mem Hospital Lin Kou, Dept Surg, Tao Yuan, Taiwan

[5] Chang Gung Univ, Tao Yuan, Taiwan

[6] Natl Hlth Res Inst, Inst Populat Hlth Sci, Zhunan, Taiwan

[7] Acad Sinica, Inst Stat Sci, Taipei 11529, Taiwan

[8] China Med Univ Hosp, Dept Surg, Taichung, Taiwan

[9] Chang Gung Mem Hospital Lin Kou, Dept Internal Med, Tao Yuan, Taiwan

[10] Vet Gen Hosp, Dept Surg, Taichung, Taiwan

[11] Vet Gen Hosp, Dept Surg, Kaohsiung, Taiwan

[12] Chang Gung Mem Hosp, Dept Surg, Kaohsiung, Taiwan

[13] Vet Gen Hosp, Dept Surg, Taipei, Taiwan

[14] Natl Taiwan Univ Hosp, Dept Internal Med, Taipei 100, Taiwan

[15] Natl Taiwan Univ, Grad Inst Clin Med, Coll Med, Taipei 10764, Taiwan

[16] Taipei Med Univ, Ctr Excellency Canc Res, Taipei, Taiwan

来源：

ANNALS OF SURGERY | 2012年 / 255卷 / 01期

关键词：

HEPATITIS-C VIRUS; TRANSCATHETER ARTERIAL EMBOLIZATION; INTRAHEPATIC RECURRENCE; ANTIVIRAL THERAPY; LIVER RESECTION; ALPHA TREATMENT; TUMOR ABLATION; CLINICAL-TRIAL; E-ANTIGEN; SURVIVAL;

D O I：

10.1097/SLA.0b013e3182363ff9

中图分类号：

R61 [外科手术学];

学科分类号：

100210 [外科学];

摘要：

Objective: To investigate the clinical efficacy of adjuvant interferon alfa-2b (IFN alpha-2b) therapy on recurrence-free survival (RFS) of patients with postoperative viral hepatitis-related hepatocellular carcinoma (HCC). Background: Despite most individual trials have failed to meet their primary endpoint, recent pooled-data meta-analyses suggest that adjuvant IFN therapy may significantly reduce the incidence of recurrence in curatively ablated HCC. Methods: Patients with curative resection of viral hepatitis-related HCC were eligible, and were stratified by underlying viral etiology and randomly allocated to receive either 53 weeks of adjuvant IFN alpha-2b treatment or observation alone. The primary endpoint of this study was RFS. Results: A total of 268 patients were enrolled with 133 in the IFN alpha-2b arm and 135 in the control arm. Eighty percent of them were hepatitis B surface antigen seropositive. At a median follow-up of 63.8 months, 154 (57.5%) patients had tumor recurrence and 84 (31.3%) were deceased. The cumulative 5-year recurrence-free and overall survival rates of intent-to-treat cohort were 44.2% and 73.9%, respectively. The median RFS in the IFN alpha-2b and control arms were 42.2 (95% confidence interval [CI], 28.1-87.1) and 48.6 (95% CI, 25.5 to infinity) months, respectively (P = 0.828, log-rank test). Adjuvant IFN alpha-2b treatment was associated with a significantly higher incidence of leucopenia and thrombocytopenia. Thirty-four (24.8%) of treated patients required dose reduction, and 5 (3.8%) of these patients subsequently withdrew from therapy because of excessive toxicity. Adjuvant IFN alpha-2b only temporarily suppressed viral replication during treatment period. Conclusions: In this study, adjuvant IFN alpha-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC. More potent antiviral therapy deserves to be explored for this patient population. This study is registered at ClinicalTrials.gov and carries the identifier NCT00149565.

引用

页码：8 / 17

页数：10

共 45 条

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