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小肝细胞癌术后是否常规需要辅助性肝动脉插管化疗栓塞的随机对照研究
徐峰,黄杨卿,李叶晟,伍路,杨甲梅*
0
(第二军医大学东方肝胆外科医院特需科,上海 200438
共同第一作者
*通信作者)
摘要:
目的 通过随机对照试验(RCT)探讨经肝动脉化疗栓塞(transchatheter arterial chemoembolization,TACE)对小肝细胞癌(small hepatocellular carcinoma,SHCC)术后复发的影响。方法 2008年9月至2009年12月接受根治性肝切除术后1个月的符合条件SHCC患者117例,随机分为两组: A组(治疗组或TACE组,59例)接受辅助性TACE治疗,B组(对照组,58例)不做任何辅助性治疗,此后定期随访并统计分析患者术后2年的无瘤生存时间及复发率。结果 中位随访时间为29个月。共有33例患者复发,1年内复发22例,全部复发发生在2年内。A组平均无瘤生存(DFS)时间为5~29(28.93±1.40)个月,B组为3~35(26.94±1.62)个月,P=0.443。A、B两组半年、1年及2年复发率分别为: 10.2% vs 13.8%,20.3% vs 20.7%,20.7% vs 31.3%(P=0.443)。单因素分析提示HBV DNA、输血、肿瘤大小(3 cm为界)及Edmondson-Steiner分级与术后早期复发相关(P<0.05)。COX多因素回归分析P<0.2的危险因素,提示HBV DNA、输血及肿瘤大小是肿瘤术后早期复发的独立危险因素。结论 对于SHCC这类复发风险相对较低的肝癌,辅助性TACE并不能减少术后早期复发,不宜作为常规预防复发的治疗方法 。其能否影响SHCC患者远期复发及总生存情况,需进一步随访证实。
关键词:  肝肿瘤  肝细胞癌  肝切除术  治疗性化学栓塞  肿瘤复发  无病生存
DOI:10.3724/SP.J.1008.2012.00274
投稿时间:2012-01-11修订日期:2012-02-13
基金项目:
Is postoperative adjuvant transchatheter arterial chemoembolization necessary for small hepatocellular carcinoma patients: a randomized controlled trial
XU Feng,HUANG Yang-qing,LI Ye-sheng,WU Lu,YANG Jia-mei*
(Department of Special Treatment, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Co-first authors.
*Corresponding author.)
Abstract:
Objective To evaluate whether adjuvant transchatheter arterial chemoembolization (TACE) can reduce early recurrence of small hepatocellular carcinoma (SHCC) patients after surgical treatment using randomized controlled trial. Methods A total of 117 patients, who underwent radical hepatectomy from Sept. 2008 to Dec. 2009, were randomly divided into 2 groups. Fifty-nine patients (group A or TACE group) received adjuvant TACE one month after hepatectomy, and 58 (group B or control group) did not receive any adjuvant therapies. Follow-up was done regularly. The disease-free survival (DFS) time and recurrence rate within the following two years were analyzed. Results The median follow-up duration was 29 months in our study. Twenty-two recurrences happened within one year and all recurrences happened within two years. The mean DFS periods were (28.93±1.40) months (range: 5-29 months) and (26.94±1.62) months (range: 3-35 months) (P=0.443) in group A and B, respectively. The half-year, 1-year and 2-year recurrence rates of group A vs group B were 10.2% vs 13.8%, 20.3% vs 20.7%, 25.7% vs 31.2% (P=0.443), respectively. Univariate analysis showed that infection of HBV DNA, blood transfusion, Edmondson-Steiner grade and tumor diameter (3 cm as cut-off point) were correlated with tumor recurrence (P<0.05). Multivariate COX regression analysis indicated that HBV DNA, blood transfusion, and tumor diameter (3 cm as cut-off point) were independent factors of early recurrence. Conclusion Adjuvant TACE can not reduce early recurrence of SHCC with a low risk of recurrence, so it is not recommended as a routine therapy to prevent early tumor recurrence. Further study is needed to verify whether TACE can benefit the long-term recurrence and overall survival of patients.
Key words:  liver neoplasms  hepatocellular carcinoma  hepatectomy  therapeutic chemoembolization  neoplasm recurrence  disease-free survival