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索拉非尼联合经动脉化疗栓塞可提高不可切除肝细胞癌患者的生存率:一项倾向评分匹配研究。

Sorafenib in combination with transarterial chemoembolization improves the survival of patients with unresectable hepatocellular carcinoma: a propensity score matching study.

机构信息

Department of Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi Province, China.

出版信息

J Dig Dis. 2013 Apr;14(4):181-90. doi: 10.1111/1751-2980.12038.

Abstract

OBJECTIVE

This prospective non-randomized controlled trial aimed to compare the efficacy of sorafenib in combination with transarterial chemoembolization (TACE) vs TACE alone for the treatment of patients with unresectable intermediate or advanced hepatocellular carcinoma.

METHODS

A total of 304 patients were enrolled, in which 82 received concurrent sorafenib (400 mg orally twice daily, initiated within 14 days after TACE), and these patients were matched with 164 patients who received TACE alone at a 1:2 ratio using propensity score matching to minimize selection bias. The response to treatment, time-to-progression (TTP), overall survival (OS) as well as adverse events were compared between the two groups.

RESULTS

During a median follow-up period of 21.4 weeks (range 0.5-103 weeks), the addition of sorafenib prolonged TTP (6.3 vs 4.3 months; hazard ratio [HR] 0.60, 95% CI 0.422-0.853, P = 0.004) and median survival (7.5 vs 5.1 months; HR 0.61, 95% CI 0.423-0.884, P = 0.009) compared with TACE alone. Significant prognostic factors for OS by multivariate analysis included the use of sorafenib, Barcelona Clinic Liver Cancer stage, metastasis/vascular invasion and Child-Pugh score.

CONCLUSIONS

The combined use of sorafenib and TACE was generally well tolerated and significantly improved OS and TTP compared with TACE alone in patients with intermediate or advanced HCC. Further studies are warranted to confirm the safety and efficacy of this combination therapy.

摘要

目的

本前瞻性非随机对照试验旨在比较索拉非尼联合经动脉化疗栓塞(TACE)与单独 TACE 治疗不可切除的中晚期肝细胞癌的疗效。

方法

共纳入 304 例患者,其中 82 例接受索拉非尼联合治疗(TACE 后 14 天内开始口服 400mg,每日两次),并采用倾向评分匹配以最小化选择偏倚,按照 1:2 的比例与 164 例单独接受 TACE 治疗的患者进行匹配。比较两组患者的治疗反应、无进展生存期(TTP)、总生存期(OS)和不良事件。

结果

中位随访 21.4 周(范围 0.5-103 周)期间,索拉非尼的加入延长了 TTP(6.3 个月 vs 4.3 个月;风险比 [HR] 0.60,95%CI 0.422-0.853,P=0.004)和中位生存时间(7.5 个月 vs 5.1 个月;HR 0.61,95%CI 0.423-0.884,P=0.009)。多因素分析显示,OS 的显著预后因素包括使用索拉非尼、巴塞罗那临床肝癌分期、转移/血管侵犯和 Child-Pugh 评分。

结论

与单独 TACE 相比,索拉非尼联合 TACE 一般耐受性良好,可显著提高中晚期 HCC 患者的 OS 和 TTP。需要进一步的研究来证实这种联合治疗的安全性和疗效。

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