近日，国际杂志Annals of Surgery刊登了来自台湾的研究人员的研究发现，他们发现，术后使用干扰素α-2b治疗不能阻止肝炎相关的肝细胞癌复发，也不能提高手术切除癌症患者的总体生存期，现在迫切需要其他组合的辅助疗法。相关研究论文“Long-Term Results of a Randomized, Observation-Controlled, Phase III Trial of Adjuvant Interferon Alfa-2b in Hepatocellular Carcinoma After Curative Resection，”刊登在了新一期的Annals of Surgery杂志上。
在这篇报告中，国立台湾大学医学院的陈医生等发现，尽管使用干扰素治疗的试验失败了，但是荟萃分析表明，在消融后使用干扰素α-2b可能有效。
研究者招募了268名病人进行随机试验，手术后辅助干扰素α-2b治疗或者没有干扰素，80%病人是HBV表面抗原阳性，其他人是C型肝炎。略超于5年的随访期发现，58%病人复发，31%死亡，意向性治疗分析发现，5年无复发生存率为44.2%，整体生存率为73.9%。
总体而言，干扰素组的中位无复发生存期为42.2个月，对照组为48.6个月。按照病因分组，HCV病人的干扰素组和对照组的无疾病进展生存期分别为42.2和31.1个月，HBV病人为42.4和49.1个月。这些差别无统计学意义。
可以预见到，干扰素组的副作用更为常见。治疗的病人白细胞减少和血小板减少的发生率显著升高。（生物谷Bioon.com）
doi:10.1097/SLA.0b013e3182363ff9
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PMID:
Long-Term Results of a Randomized, Observation-Controlled, Phase III Trial of Adjuvant Interferon Alfa-2b in Hepatocellular Carcinoma After Curative Resection.
Chen, Li-Tzong MD, PhD*,†,‡; Chen, Miin-Fu MD§; Li, Lung-An PhD¶,‖; Lee, Po-Huang MD, PhD***; Jeng, Long-Bin MD††; Lin, Deng-Yn MD‡‡; Wu, Cheng-Chung MD§§; Mok, King-Tong MD¶¶; Chen, Chao-Long MD***; Lee, Wei-Chen MD§; Chau, Gar-Yang MD†††; Chen, Yaw-Sen MD***; Lui, Wing-Yui MD§§; Hsiao, Chin-Fu PhD¶; Whang-Peng, Jacqueline MD*,¶¶¶; Chen, Pei-Jer MD, PhD‡‡‡,§§§
Objective: To investigate the clinical efficacy of adjuvant interferon alfa-2b (IFNα-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 IFNα-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 IFNα-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 IFNα-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 IFNα-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 IFNα-2b only temporarily suppressed viral replication during treatment period. Conclusions: In this study, adjuvant IFNα-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.
