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Clinical Characteristics of Long-Term Survivors After Sorafenib Treatment for Unresectable Hepatocellular Carcinoma: A Korean National Multicenter Retrospective Cohort Study
Journal of Hepatocellular Carcinoma ( IF 4.1 ) Pub Date : 2021-06-18 , DOI: 10.2147/jhc.s304439
Young Youn Cho 1, 2 , Su Jong Yu 1 , Hye Won Lee 3 , Do Young Kim 3 , Wonseok Kang 4 , Yong-Han Paik 4 , Pil Soo Sung 5 , Si Hyun Bae 6 , Su Cheol Park 7 , Young Seok Doh 8, 9 , Kang Mo Kim 9 , Eun Sun Jang 10 , In Hee Kim 11 , Won Kim 12 , Yoon Jun Kim 1
Affiliation  

Background/Aim: Sorafenib is the first systemic therapy for the treatment of advanced-stage hepatocellular carcinoma (HCC) and progressive HCC after locoregional therapy. The aim of this study was to evaluate the prognostic factors of long-term survivors after sorafenib treatment.
Methods: This multicenter, retrospective, cohort study included 1,566 unresectable HCC patients who received sorafenib treatment between 2007 and 2014 in nine tertiary centers in Korea. The patients were classified into a long-term survivor group (survival more than two years, n = 257) or a control group (n = 1309). The primary outcomes were the prognostic factors affecting long-term survival. Secondary endpoints included time-to-progression and other safety profiles.
Results: The patients were predominantly men (83.8%) with chronic hepatitis B (77.3%) and Barcelona clinic of liver cancer-stage C (BCLC-C) (78.3%). The median overall survival was 9.0 months. After treatment, eight patients (0.4%) achieved complete response and 139 patients (8.8%) achieved partial response according to the mRECIST criteria. The prognostic factors predicting long-term survival were metformin use (adjusted hazard ratio [aHR] = 3.464; P < 0.001), hand-foot skin reaction (aHR = 1.688; P = 0.003), and concomitant treatment with chemoembolization or radiotherapy (aHR = 2.766; P < 0.001). Poor prognostic factors of long-term survival were a Child-Pugh score of B (HR = 0.422; P < 0.001), the presence of extrahepatic metastasis (HR = 0.639; P = 0.005), main portal vein invasion (HR = 0.502; P = 0.001), and elevated alpha-fetoprotein (> 1,000 ng/mL; HR = 0.361; P < 0.001).
Conclusion: This large, multicenter, retrospective study showed an objective response rate of 9.1% and a proportion of long-term survivors of 16.4% in Korean patients. The prognostic factors derived in our study can be used in clinical practice during sorafenib treatment.

Keywords: sorafenib, hepatocellular carcinoma, prognosis, survival


中文翻译:

索拉非尼治疗不可切除的肝细胞癌后长期幸存者的临床特征:韩国国家多中心回顾性队列研究

背景/目的:索拉非尼是首个用于治疗晚期肝细胞癌(HCC)和局部区域治疗后进行性HCC的全身疗法。本研究的目的是评估索拉非尼治疗后长期幸存者的预后因素。
方法:这项多中心、回顾性、队列研究包括 2007 年至 2014 年间在韩国九个三级中心接受索拉非尼治疗的 1,566 名不可切除的 HCC 患者。患者被分为长期存活组(存活超过两年,n = 257)或对照组(n = 1309)。主要结果是影响长期生存的预后因素。次要终点包括进展时间和其他安全概况。
结果:患者主要是男性(83.8%)慢性乙型肝炎(77.3%)和肝癌 C 期(BCLC-C)巴塞罗那诊所(78.3%)。中位总生存期为 9.0 个月。根据 mRECIST 标准,治疗后,8 名患者 (0.4%) 达到完全缓解,139 名患者 (8.8%) 达到部分缓解。预测长期生存的预后因素是二甲双胍的使用(调整后的风险比 [aHR] = 3.464;P < 0.001)、手足皮肤反应(aHR = 1.688;P = 0.003)以及化疗栓塞或放疗的伴随治疗(aHR = 2.766;P < 0.001)。长期生存的不良预后因素是 Child-Pugh 评分为 B (HR = 0.422; P < 0.001)、存在肝外转移 (HR = 0.639; P = 0.005)、主门静脉侵犯 (HR = 0.502; P = 0.001),甲胎蛋白升高(> 1,000 纳克/毫升;人力资源 = 0.361;P < 0.001)。
结论:这项大型、多中心、回顾性研究显示,韩国患者的客观缓解率为 9.1%,长期幸存者比例为 16.4%。我们研究中得出的预后因素可用于索拉非尼治疗期间的临床实践。

关键词:索拉非尼,肝细胞癌,预后,生存
更新日期:2021-06-18
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