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中华肝脏外科手术学电子杂志 ›› 2021, Vol. 10 ›› Issue (04) : 403 -408. doi: 10.3877/cma.j.issn.2095-3232.2021.04.014

临床研究

索拉非尼治疗后完全缓解肝癌患者"等待观察"策略安全性分析
郭平1, 袁瑾2, 周彦明1,()   
  1. 1. 361003 厦门大学附属第一医院肝胆胰血管外科
    2. 361003 厦门大学附属第一医院皮肤病与性病学
  • 收稿日期:2021-02-02 出版日期:2021-08-18
  • 通信作者: 周彦明
  • 基金资助:
    福建省科技厅卫生联合面上项目(2019J01570)

Safety of wait-and-see strategy for primary liver cancer patients with complete response after sorafenib treatment

Ping Guo1, Jin Yuan2, Yanming Zhou1,()   

  1. 1. Department of Hepatobiliary, Pancreatic and Vascular Surgery, the First Affiliated Hospital of Xiamen University, Xiamen 361003, China
    2. Department of Dermatology and Venereology, the First Affiliated Hospital of Xiamen University, Xiamen 361003, China
  • Received:2021-02-02 Published:2021-08-18
  • Corresponding author: Yanming Zhou
引用本文:

郭平, 袁瑾, 周彦明. 索拉非尼治疗后完全缓解肝癌患者"等待观察"策略安全性分析[J/OL]. 中华肝脏外科手术学电子杂志, 2021, 10(04): 403-408.

Ping Guo, Jin Yuan, Yanming Zhou. Safety of wait-and-see strategy for primary liver cancer patients with complete response after sorafenib treatment[J/OL]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2021, 10(04): 403-408.

目的

探讨索拉非尼治疗后完全缓解的肝细胞癌(肝癌)患者采用"等待观察"策略的安全性和可行性。

方法

报道1例肝癌患者接受介入联合索拉非尼治疗达到完全病理缓解。患者已签署知情同意书,符合医学伦理学规定。检索2007年1月至2020年4月PubMed、Embase、Ovid、万方、中国知网、维普网等数据库收录的中英文临床研究文献。英文检索词:"hepatocellular carcinoma"、"sorafenib"、"complete response"、"complete pathological response"。中文检索词:"肝癌"、"索拉非尼"、"完全缓解"、"完全病理缓解"。统计以索拉非尼为基础治疗后完全缓解患者术后1、3、5年总体生存率和无进展生存率。生存分析采用Kaplan-Meier法和Log-rank检验。

结果

共纳入37篇文献,总计肝癌患者45例,其中男39例,女6例。患者术后1、3、5年总体生存率分别为100%、94.3%、94.3%,无进展生存率分别为100%、89.3%、89.3%。患者性别、年龄、AFP水平、BCLC分期、门静脉癌栓、肝外转移、病毒性肝炎情况、是否全量使用索拉非尼、治疗方案、是否行肝肿瘤切除、缓解情况等因素均不影响患者生存时间(χ2=0.260,1.411,0.219,0.852,0.087,1.838,0.916,1.065,0.539,0.027,0.590;P>0.05)及疾病复发(χ2=0.409,1.899,1.455,3.300,0.853,0.557,1.220,0.006,2.790,0.894,0.384;P>0.05 )。

结论

以索拉非尼为基础治疗获完全缓解的肝癌患者生存预后明显改善,缓解后采用"等待观察"可能是一种安全有效的策略,不推荐进行肝癌切除或介入治疗。

Objective

To evaluate the safety and feasibility of wait-and-see strategy for primary liver cancer (PLC) patients with complete response after sorafenib treatment.

Methods

1 case of PLC who achieved pathological complete response after interventional therapy combined with sorafenib therapy was reported. The informed consent of this patient was obtained and the local ethical committee approval was received. Relevant clinical studies were searched from PubMed, Embase, Ovid, Wanfang, CNKI and Chongqing VIP databases from January 2007 to April 2020 using the keywords hepatocellular carcinoma, sorafenib, complete response, complete pathological response in both Chinese and English. The 1-, 3- and 5-year overall survival and progression-free survival of PLC patients with complete response after sorafenib-based treatments were calculated. Survival analysis was conducted by Kaplan-Meier method and Log-rank test.

Results

37 articles of 45 PLC patients, 39 male and 6 female, were included. The 1-, 3-, and 5-year overall survival rates were 100%, 94.3%, and 94.3%, and the progression-free survival rates were 100%, 89.3%, and 89.3%, respectively. Gender, age, AFP level, BCLC staging, portal vein tumor thrombus, extrahepatic metastasis, viral hepatitis, use of full-dose sorafenib, therapeutic regimen, resection of liver tumor and condition of remission were not significantly associated with the survival of patients (χ2=0.260, 1.411, 0.219, 0.852, 0.087, 1.838, 0.916, 1.065, 0.539, 0.027, 0.590; P>0.05) and disease recurrence (χ2=0.409, 1.899, 1.455, 3.300, 0.853, 0.557, 1.220, 0.006, 2.790, 0.894, 0.384; P>0.05).

Conclusions

PLC patients who achieve complete response after sorafenib-based treatments can obtain favorable clinical prognosis. Application of wait-and-see strategy is a safe option. Liver tumor resection or interventional therapy is not recommended.

图1 一例以索拉非尼为基础治疗后完全缓解肝癌患者MRI及病理检查
表1 以索拉非尼为基础治疗后完全缓解肝癌患者基本信息
图2 以索拉非尼为基础治疗后完全缓解肝癌患者Kaplan-Meier生存曲线
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