近日,，國(guó)際雜志Annals of Surgery刊登了來(lái)自臺(tái)灣的研究人員的研究發(fā)現(xiàn)，他們發(fā)現(xiàn),，術(shù)后使用干擾素α-2b治療不能阻止肝炎相關(guān)的肝細(xì)胞癌復(fù)發(fā),，也不能提高手術(shù)切除癌癥患者的總體生存期，現(xiàn)在迫切需要其他組合的輔助療法,。相關(guān)研究論文“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雜志上。
在這篇報(bào)告中,，國(guó)立臺(tái)灣大學(xué)醫(yī)學(xué)院的陳醫(yī)生等發(fā)現(xiàn),，盡管使用干擾素治療的試驗(yàn)失敗了，但是薈萃分析表明，在消融后使用干擾素α-2b可能有效,。
研究者招募了268名病人進(jìn)行隨機(jī)試驗(yàn),，手術(shù)后輔助干擾素α-2b治療或者沒(méi)有干擾素，80%病人是HBV表面抗原陽(yáng)性,，其他人是C型肝炎,。略超于5年的隨訪期發(fā)現(xiàn)，58%病人復(fù)發(fā),，31%死亡,，意向性治療分析發(fā)現(xiàn)，5年無(wú)復(fù)發(fā)生存率為44.2%,，整體生存率為73.9%,。
總體而言，干擾素組的中位無(wú)復(fù)發(fā)生存期為42.2個(gè)月,，對(duì)照組為48.6個(gè)月,。按照病因分組，HCV病人的干擾素組和對(duì)照組的無(wú)疾病進(jìn)展生存期分別為42.2和31.1個(gè)月,，HBV病人為42.4和49.1個(gè)月,。這些差別無(wú)統(tǒng)計(jì)學(xué)意義。
可以預(yù)見(jiàn)到,，干擾素組的副作用更為常見(jiàn),。治療的病人白細(xì)胞減少和血小板減少的發(fā)生率顯著升高。（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.
