Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study
Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study
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乙肝相关肝细胞癌切除后辅助经动脉化疗栓塞：一项随机对照研究
DOI：
10.1158/1078-0432.ccr-17-2899
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发表时间：
2018-05-01
影响因子：
11.5
通讯作者：
Zhou, Jian
中科院分区：
文献类型：
--
作者：
Wang, Zheng;Ren, Zhenggang;Zhou, Jian
目的：肝细胞癌（HCC）根治性切除术后复发患者的生存率通常很低。我们试图评估辅助性经动脉化疗栓塞（TACE）在中度（单个肿瘤大于5 cm，无微血管浸润）或高风险（单个肿瘤有微血管浸润，或两个或三个肿瘤）复发的HBV相关HCC患者中的安全性和有效性。实验设计：在这项随机III期试验中，280例合格患者被分配到辅助TACE组（n = 140）或无辅助治疗组（对照组; n = 140）。主要终点是无复发生存期（RFS）;次要终点包括总生存期（OS）和安全性。多变量Cox比例风险模型用于确定TACE对患者结局的独立影响。结果如下：接受辅助TACE的患者的RFS显著长于对照组[56.0% vs. 42.1%，P = 0.01; HR，0.68; 95%置信区间（CI），0.49-0.93]。辅助TACE组患者的3年OS率比对照组高7.8%（85.2% vs. 77.4%; P = 0.04; HR，0.59; 95% CI，0.36-0.97）。在控制其他已知预后因素后，辅助TACE对RFS和OS的影响仍然显著（RFS的HR为0.67; P = 0.01; OS的HR为0.59; P = 0.04）。辅助TACE后无3级或4级毒性。结论：对于治疗性肝切除术后有中度或高度复发风险的HBV相关HCC患者，我们的研究显示辅助TACE显著降低了肿瘤复发，改善了RFS和OS，并且该手术耐受性良好。临床癌症研究; 24（9）; 2074-81。©2018 AACR.
Purpose: The survival of patients with hepatocellular carcinoma (HCC) recurrence after curative resection is usually poor. We sought to evaluate the safety and efficacy of adjuvant transarterial chemoembolization (TACE) in HBV-related HCC patients with an intermediate (a single tumor larger than 5 cm without microvascular invasion) or high risk (a single tumor with microvascular invasion, or two or three tumors) of recurrence. Experimental Design: In this randomized phase 3 trial, 280 eligible patients were assigned to adjuvant TACE (n = 140) or no adjuvant treatment (control; n = 140) groups. The primary endpoint was recurrence-free survival (RFS); secondary endpoints included overall survival (OS) and safety. Multivariable Cox-proportional hazards model was used to determine the independent impact of TACE on patients' outcomes. Results: Patients who received adjuvant TACE had a significantly longer RFS than those in the control group [56.0% vs. 42.1%, P = 0.01; HR, 0.68; 95% confidence interval (CI), 0.49–0.93]. Patients in the adjuvant TACE group had 7.8% higher 3-year OS rate than the control group (85.2% vs. 77.4%; P = 0.04; HR, 0.59; 95% CI, 0.36–0.97). The impact of adjuvant TACE on RFS and OS remained significant after controlling for other known prognostic factors (HR, 0.67; P = 0.01 for RFS; and HR, 0.59; P = 0.04 for OS). There was no grade 3 or 4 toxicity after adjuvant TACE. Conclusions: For patients with HBV-related HCC who had an intermediate or high risk of recurrence after curative hepatectomy, our study showed adjuvant TACE significantly reduced tumor recurrence, improved RFS and OS, and the procedure was well tolerated. Clin Cancer Res; 24(9); 2074–81. ©2018 AACR.