雷替曲塞介入治疗中晚期原发性肝癌的疗效及安全性分析

摘要

Objective To evaluate efficacy and safety of advanced primary hepatic carcinoma( PHC) by transcatheter arterial chemoembolization(TACE) with raltitrexed treatment. Methods All 95 patients with advanced PHC confirmed by pathology or clinical diagnosis were enrolled from January 2012 to December 2013, dividing into experimental group ( n=37) and control group ( n=58) . Experimental group:raltitrexed ( 3 mg/m2 ) plus oxaliplatin ( 100 mg/m2 ) , pirarubicin ( 40 mg/m2 ) in TACE treatment, while control group:FUDR (1�0 g) combined with oxaliplatin (100 mg/m2), pirarubicin (40 mg/m2). Repeated treatment was given every 4⁃6 weeks and efficacy was evaluated after four weeks in accordance with the modified RECIST criteria ( mRECISIT) , until effi⁃cacy evaluation for complete remission ( CR) , liver function Child⁃pugh C level or intolerable complications were occured. The response rate(RR), disease control rate(DCR), decreasing rate of alpha⁃fetoprotein (AFP), progression free survival (PFS) and the incidence of adverse reactions were assessed, and the results were compared between the two groups. Results In experimental group and control group, the RR was 35�1% and 32�7%( P>0�05) , AFP decreasing rate was 40�5% and 31�0%( P>0�05) , the median PFS was 7 and 5 months(P>0�05), DCR were 86�5%, 67�2%(P=0�035),respectively. The main adverse events in both groups were nausea, vomiting, bone marrow suppression, fever and transaminase increase, the difference was not statistically significant ( P>0�05) . Conclusion Preliminary study has shown that the short⁃term curative effect of PHC by TACE with raltitrexed treatment is ex⁃act and the toxicity can be tolerated. But it still needs a large randomized controlled study to confirm the results.%目的：探讨雷替曲塞在动脉化疗栓塞（ TACE）治疗中晚期原发性肝癌中的疗效及安全性。方法收集2012年1月至2013年12月经病理组织学检查证实或临床诊断的中晚期原发性肝癌患者95例，分为试验组（ n＝37）和对照组（ n＝58）。试验组：雷替曲塞（3 mg／m2）联合奥沙利铂（100 mg／m2）、吡柔比星（40 mg／m2）行TACE治疗；对照组：氟脲苷（1�0 g）联合奥沙利铂（100 mg／m2）、吡柔比星（40 mg／m2）行TACE治疗。每4～6周为1个疗程，TACE术后4周根据改良的实体瘤疗效评价标准（ mRECIST）评价疗效，直至疗效评价完全缓解或出现肝功能Child⁃pugh C级及不可耐受的并发症。评价两组介入治疗的有效率（RR）、疾病控制率（DCR）、甲胎蛋白（AFP）下降率、无疾病进展时间（PFS）及不良反应发生率。结果试验组和对照组的RR分别为35�1％、32�7％（ P＞0�05），AFP下降率分别为40�5％、31�0％（ P＞0�05），中位PFS分别为7个月和5个月（ P＞0�05）；DCR分别为86�5％、67�2％（ P＝0�035）。两组的不良反应主要为恶心、呕吐、骨髓抑制、发热及转氨酶升高等，差异均无统计学意义（ P＞0�05）。结论雷替曲塞替代氟脲苷在TACE治疗中晚期原发性肝癌近期疗效相当，毒副反应可耐受，但尚有待大样本随机对照研究加以证实。