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中国癌症防治杂志

中国癌症防治杂志 ›› 2015, Vol. 7 ›› Issue (3): 213-218.doi: 10.3969/j.issn.1674-5671.2015.03.16

• 临床研究 • 上一篇    下一篇

索拉非尼治疗晚期原发性肝癌的疗效和影响因素分析

  

  1. 广西医科大学附属肿瘤医院化疗一科；广西医科大学研究生学院
  • 出版日期:2015-06-25 发布日期:2015-07-13
  • 通讯作者: 刘志辉 lzhh101@sina.com

Factors affecting efficacy and safety of sorafenib for advanced primary liver cancer

  • Online:2015-06-25 Published:2015-07-13

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被引次数

3

摘要：

目的 评价索拉非尼治疗晚期原发性肝癌的疗效和不良反应，分析影响疗效的因素。方法 回顾性收集2008年1月至2013年9月在广西医科大学附属肿瘤医院应用索拉非尼治疗的晚期原发性肝癌患者完整的临床资料。计算缓解率和疾病控制率（DCR）并进行Logistic回归分析影响因素，运用Kaplan-Meier法估计总生存期和无疾病进展生存期，并采用Cox风险比例模型分析其影响因素。结果 共收集78 例患者资料，中位随访时间为192 d（95％CI：173~218）。无一例患者获得完全缓解（CR）或部分缓解（PR），稳定（ＳＤ）48例（61.5%），进展（ＰＤ）30例（38.5%）。中位生存期（mOS）和中位无疾病进展生存期（mPFS）分别为196 d（95%CI：173~218）和96 d（95%CI：93~98）。不良反应大多数为1~2级，手足皮肤反应是影响索拉非尼治疗的最主要因素。年龄、血清乙型肝炎表面抗原阳性（乙肝病毒感染）是ＤＣＲ的独立影响因素。肝功能（Child-Pugh）分级、既往化疗是影响无疾病进展生存期及总生存期的独立预后因素，美国东部肿瘤协作组活动状态评分（ECOG　PS）是另一个影响总生存期的独立预后因素。结论 索拉非尼治疗晚期原发性肝癌有较好的疾病控制率，安全性较好。ECOG　PS评分、Child-Pugh 分级、既往化疗是影响患者生存的主要因素。

关键词: 原发性肝癌, 索拉非尼, 化疗, 疗效, 影响因素

Abstract:

Objective To evaluate the efficacy and safety of sorafenib in the treatment of advanced primary liver cancer and analyze factors that may affect drug outcomes. Methods Medical records of 78 patients with advanced primary liver cancer who received sorafenib from January 2008 to September 2013 were analyzed. Logistic regression was used to identify variables influencing response rate and disease control rate. Overall survival and progression-free survival were estimated using the Kaplan-Meier method， and Cox proportional hazard multivariate modeling was used to identify prognostic factors. Results Median follow-up time for the 78 patients was 192 days（95%CI 173-218）. No complete remission or partial remission was observed，and stable disease occurred in 48 patients（61.5%），corresponding to a disease control rate of 61.5%. Disease progression occurred in 30 patients. Median overall survival was 196 days （95%CI 173-218） and median progression-free survival was 96 days（95%CI 93-98）. Multivariate analysis identified age and HBV infection as independent risk factors for disease control rate. Child-Pugh class and previous chemotherapy were identified as independent prognostic factors of overall and progression-free survival. ECOG performance status was also found to be an independent predictor of overall survival. Most adverse events were grade 1 or 2. Two patients experienced grade IV hand-foot syndrome. No treatment-related deaths were recorded. Conclusion Sorafenib shows substantial survival benefit and tolerable toxicity in patients with advanced primary liver cancer. Lower ECOG performance status， Child-Pugh A class and previous chemotherapy predict better survival.

Key words: Liver neoplasm, Sorafenib, Chemotherapy, Efficacy, Prognostic factors