胆道肿瘤专题研究(Monographic Study of Biliary Tract Neoplasms)

索拉非尼治疗进展期胆管细胞型肝癌的临床观察

Published at: 2015年第24卷第2期

潘婷婷 1 , 荚卫东 1 , 许戈良 1
1 安徽医科大学附属省立医院 肝脏外科/ 肝胆胰外科安徽省重点实验室,安徽 合肥 230001
通讯作者 卫东 荚 Email: jwd1968@sina.com
DOI: 10.3978/j.issn.1005-6947.10.3978/j.issn.1005-6947.2015.02.002
基金:
国家自然科学基金资助项目 81172364

摘要

目的:观察索拉非尼治疗进展期胆管细胞型肝癌(CCC)的临床疗效及毒性反应。方法:15例进展期CCC患者口服索拉非尼400 mg,2次/d,3周为一个周期,持续用药,直至病情进展或出现不可耐受的毒性反应。观察服药12周时的有效率(RR)和疾病控制率(DCR),次要观 察指标包括至疾病进展时间(TTP),无进展生存期(PFS),总生存期(OS),治疗持续时间(DOT)和毒性反应。结果:15例患者中位DOT是3.2(1.5~30)个月;按照RECIST 标准评价部分缓解4例,病情稳定7例,疾病进展4例;12周时RR为26.7%,DCR为73.3%;中位TTP,PFS及OS分别为3.2、5.5和5.7个月;治疗期间出现不良反应者9例,最常见的毒副反应是1~2级皮疹(33.3%),出现3级手足综合征1例(6.7%)。结论:索拉非尼对进展期CCC患者治疗有效,其不良反应可以耐受。


Clinical observation of sorafenib for advanced cholangiocellular carcinoma

Abstract

Objective: To observe the clinical efficacy and toxic effect of sorafenib in treatment of advanced cholangiocellular carcinoma (CCC). Methods: Fifteen patients with advanced CCC were enrolled and underwent continuous oral sorafenib administration at a dose of 400 mg twice daily with 3 weeks as a treatment cycle until disease progression or intolerant drug-related toxicity. The primary endpoints included response rate (RR) and the disease control rate (DCR) at 12 weeks, and the secondary endpoints included time to progression (TTP), progression-free survival (PFS), overall survival (OS), duration of treatment (DOT) and toxicity. Results: In the 15 patients, the median DOT was 3.2 (1.5-30) months, 4 cases achieved a partial response and 7 cases obtained a stable disease, according to RECIST criteria. The median TTP, PFS and OS was 3.2, 5.5 and 5.7 months, respectively. Treatment-related adverse reactions occurred in 9 cases, in which the grade 1-2 skin rash was most common toxicity reaction (33.3%), and grade 3 hand-foot syndrome occurred in one case (6.7%). Conclusion: Sorafenib monotherapy has proven efficacy and manageable toxicity in advanced CCC.


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引用

引用本文: 婷婷 潘, 卫东 荚, 戈良 许. 索拉非尼治疗进展期胆管细胞型肝癌的临床观察[J]. 中国普通外科杂志, 2015, 24(2): 163-169.
Cite this article as: PAN Tingting, JIA Weidong, XU Geliang . Clinical observation of sorafenib for advanced cholangiocellular carcinoma[J]. Chin J Gen Surg, 2015, 24(2): 163-169.