Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon a-2b for advanced hepatocellular carcinoma with portal venous invasion
Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon a-2b for advanced hepatocellular carcinoma with portal venous invasion
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DOI：
10.1002/cncr.26648
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发表时间：
2012-07-01
期刊：
影响因子：
6.2
通讯作者：
Suzuki, Kazuyuki
中科院分区：
文献类型：
--
作者：
Kasai, Kazuhiro;Ushio, Akira;Suzuki, Kazuyuki
背景技术背景：晚期肝细胞癌（HCC）的预后仍然很差，特别是在门静脉肿瘤血栓形成（PVTT）患者中。本研究评价了5-氟尿嘧啶联合聚乙二醇干扰素（PEG-IFN）a-2b治疗晚期肝癌的疗效。方法：受试者包括59名患有PVTT的HCC患者，使用PEG-IFNa-2b（每周第1天50-100 μ g，持续4周）的皮下给药和5-氟尿嘧啶（每周第1-5天250 mg/d，持续5小时，持续4周）的动脉内输注进行治疗。每4周为1个疗程。疾病进展（PD）患者停止当前治疗。对于PD以外的缓解，重复治疗≥ 1个周期。主要疗效终点为客观早期缓解率。次要疗效终点为无进展生存期（PFS）和总生存期。结果：客观有效率为73.0%。6个月时的累积PFS率为67.4%，12个月时为30.2%，18个月时为25.9%，24个月时为20.7%。中位PFS为9.7个月。6个月、12个月、24个月和36个月的累积生存率分别为82.4%、73.6%、52.8%和44.0%。中位生存时间为29.9个月。所有不良反应均可通过暂停治疗控制。未观察到严重并发症和治疗相关死亡。结论：尽管需要使用更大的晚期HCC患者人群进行前瞻性随机对照试验来评估5-氟尿嘧啶和PEG-IFNa-2b的联合治疗，但这种新的联合治疗可能对晚期HCC患者有用。癌症2011年。(c)2011年美国癌症协会
BACKGROUND: The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) a-2b in patients with advanced HCC. METHODS: Subjects comprised 59 HCC patients with PVTT treated using subcutaneous administration of PEG-IFNa-2b (50-100 mu g on day 1 of each week for 4 weeks) and intra-arterial infusion of 5-fluorouracil (250 mg/d for 5 hours on days 1-5 of each week for 4 weeks). One treatment cycle lasted 4 weeks. The current therapy was discontinued in patients with progressive disease (PD). For responses other than PD, treatment was repeated for =1 cycle. The primary efficacy endpoint was the objective early response rate. Secondary efficacy endpoints were progression-free survival (PFS) and overall survival. RESULTS: Objective early response rate was 73.0%. Cumulative PFS rates were 67.4% at 6 months, 30.2% at 12 months, 25.9% at 18 months, and 20.7% at 24 months. Median PFS was 9.7 months. Cumulative survival rates were 82.4% at 6 months, 73.6% at 12 months, 52.8% at 24 months, and 44.0% at 36 months. Median survival time was 29.9 months. All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment-related deaths were not observed. CONCLUSIONS: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNa-2b, this new combination therapy may be useful for patients with advanced HCC. Cancer 2011. (c) 2011 American Cancer Society.