Li Maoquan, Lu Chenhui, Cheng Jie, Zhang Jiaxing, Cao Chuanwu, Xu Jiahua, Xu Jichong, Pan Hui, Zhong Baoliang, Tucker Steven, Wang Daoyuan
Department of Interventional Radiology, Shanghai 10th People Hospital, Medical School of Tongji University, Shanghai, China.
J Gastroenterol Hepatol. 2009 Aug;24(8):1437-44. doi: 10.1111/j.1440-1746.2009.05863.x. Epub 2009 May 28.
The present study was carried out to test the hypothesis that interferon-alpha (IFN-alpha) treatment would reduce or postpone the recurrence rate and improve the overall survival rate in patients after transarterial chemoembolization (TACE) treatment of hepatitis B virus (HBV) related unresectable hepatocellular carcinoma (HCC).
216 patients with unresectable HBV-related HCC were randomized into a TACE group and a TACE-IFN group, each group had 108 patients. In the TACE-IFN group, patients received IFN-alpha1b at a dose of 3 million units (mu) three times a week by intramuscular injection one week after/before TACE treatment, for 48 weeks.
The median disease-free survival in the TACE-IFN treatment group was 23.6 months (95% CI: 21.4-25.8) and 20.3 months (95% CI: 15.8-24.8) in the TACE group (P = 0.027). The disease free rate at 24 months in the TACE group was lower than in the TACE-IFN group (39.8% vs 59.3%, P = 0.004). The median overall survival was 29 months (95% CI: 27.5-32.1) in the TACE-IFN group and 26 months (95% CI: 20.1-31.9) in the TACE group (P = 0.003). The 2-year overall survival in the TACE-IFN group was higher than in the TACE group (72.2% vs 52.8%, P = 0.003).
IFN-alpha treatment reduced recurrence and improved the survival of patients after TACE treatment of HBV-related HCC, with acceptable toxicities.
本研究旨在验证以下假设，即对于乙型肝炎病毒（HBV）相关不可切除肝细胞癌（HCC）患者，经动脉化疗栓塞（TACE）治疗后，使用α干扰素（IFN-α）治疗可降低或推迟复发率，并提高总生存率。
将216例HBV相关不可切除HCC患者随机分为TACE组和TACE-IFN组，每组108例。在TACE-IFN组中，患者在TACE治疗后/前1周开始，每周3次肌肉注射剂量为300万单位（mu）的α1b干扰素，共48周。
TACE-IFN治疗组的无病生存期中位数为23.6个月（95%CI：21.4-25.8），TACE组为20.3个月（95%CI：15.8-24.8）（P = 0.027）。TACE组24个月时的无病率低于TACE-IFN组（39.8%对59.3%，P = 0.004）。TACE-IFN组的总生存期中位数为29个月（95%CI：27.5-32.1），TACE组为26个月（95%CI：20.1-31.9）（P = 0.003）。TACE-IFN组的2年总生存率高于TACE组（72.2%对52.8%，P = 0.003）。
IFN-α治疗可降低HBV相关HCC患者TACE治疗后的复发率并提高生存率，且毒性可接受。
