肝动脉化疗栓塞术早期序贯经皮射频消融术在合并乙型肝炎肝硬化的大肝癌中的疗效和安全性分析

Safety and efficacy of transcatheter arterial chemoembolization plus early sequential percutaneous radiofrequency ablation for the treatment of large primary liver cancer with hepatitis B cirrhosis: a single-center experience

目的探讨肝动脉化疗栓塞（TACE）早期序贯经皮射频消融（RFA）术治疗合并乙型肝炎肝硬化的大肝癌中的临床效果及安全性。方法选取2010年10月至2013年12月诊治的合并乙型肝炎肝硬化大肝癌患者,患者至少有1个肿瘤最大径≥5 cm。D1行TACE术。D5±2行RFA术。其中主要观察终点为至疾病进展时间（TTP）;次要观察终点为客观有效率（ORR）、总生存期（OS）和安全性。结果共45例患者入组,分为Child-Pugh A级25例（A组）、Child-Pugh B级20例（B组）。患者中位年龄为56岁（39-78岁）。中位随访期为746天（90-1410天）。TACE联合RFA治疗相关的不良事件多为轻至中度,最常见的包括ALT升高（88.9%）、发热（86.7%）,AST升高（84.4%）。两组患者安全性方面比较,差异无统计学意义。两组患者近期疗效TTP及ORR比较,差异均无统计学意义（P均〉0.05）。A组较B组OS有延长趋势,中位OS分别为532、302天,差异无统计学意义（P=0.211）。多因素结果分析显示,治疗有效为TTP独立预后良好因素（P=0.011）;HBe Ag阳性显著增加疾病进展风险（HR=2.741,P=0.023）。结论采取TACE早期序贯RFA治疗合并乙型肝炎肝硬化的大肝癌是安全、有效的治疗方法,肝脏损害并未因肝功能基线差异而有显著差异。近期疗效是决定大肝癌患者预后的重要因素。

Objective To assess the safety and effi cacy of transcatheter arterial chemoembolization（TACE） plus early squential percutaneous CT-guided radiofrequency ablation（RFA） in large primary liver cancer（PLC） with hepatitis B cirrhosis. Methods From October 2010 to September 2013, PLC with hepatitis B cirrhosis patients（at least one tumor ≥ 5 cm in diameter） received lipiodol-based TACE on D1. Then CTguided RFA was done on D5 ± 2. The primary end point was time to progression（TTP）. The secondary end points included objective response rate（ORR）, overall survival（OS） and safety. Results Total of 45 patients were divided into group A（Child-Pugh A, 25 cases） and group B（Child-Pugh B, 20 cases）. The median age of the cohort was 56 years（39-78 years）. Median follow-up time was 746 days（90-1410 days）. TACE plus RFA treatment-related adverse events were mainly mild to moderate, with 40 cases of ALT elevation（88.9%）, 39 cases of fever（86.7%）, 38 cases of AST elevation（84.4%）. The two groups had similar treatment-emergent safety profi les. The differences in TTP and ORR between two groups were statistically insignifi cant（P 0.05）. The median OS time of group A was longer than that of group B, 532 and 302 days, respectively, but no signifi cant difference was found（P = 0.211）. Multivariate analysis revealed that tumor response was identifi ed as an independent favorable prognostic factor for TTP（P = 0.011）. However, cases with HBe Ag positive had increased risk of disease progression, HR = 2.741（P = 0.023）. Conclusions TACE plus early sequential RFA combined hepatitis B cirrhosis of the liver is safe and effective treatment of liver cancer. No signifi cant differences in liver damage caused by sequential treatment was demonstrated based on different baseline liver function. The short-term curative effect is an important factor to determine the prognostic of patients with large liver cancer.