Sorafenib for hepatocellular carcinoma according to Child-Pugh class of liver function
Sorafenib for hepatocellular carcinoma according to Child-Pugh class of liver function
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DOI：
10.1007/s00280-011-1616-x
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发表时间：
2011-11-01
影响因子：
3
通讯作者：
Kang, Yoon-Koo
中科院分区：
文献类型：
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作者：
Kim, Jeong Eun;Ryoo, Baek-Yeol;Kang, Yoon-Koo
我们比较了索拉非尼在Child - Pugh（CP）B级和CP A级患者中的疗效和安全性。回顾了267例接受索拉非尼治疗的肝细胞癌（HCC）患者的临床资料。根据CP评分（5 - 6分、7分和8 - 9分）对患者进行分组，并评估其肿瘤反应、耐受性和生存期。患者中位年龄为55岁，87.6%为男性。性别、HCC病因和肝外转移在不同CP评分组之间无差异。在225例可评估的患者中，4例达到部分缓解，121例达到疾病稳定，疾病控制率为46.8%。CP A级患者的疾病控制率（DCR）高于CP B级患者，但CP评分为7分和8 - 9分的患者之间无差异。3/4级毒性的发生率在不同CP评分组之间无差异。许多CP评分为8 - 9分的患者（26.3%）因肝硬化相关并发症不得不停用索拉非尼。中位随访15.6个月时，所有患者的中位疾病进展时间和总生存期分别为2.6个月和7.9个月。CP评分为5 - 6分的患者总生存期（OS）长于CP评分为7分或8 - 9分的患者。索拉非尼在CP B级肝功能患者中的疗效和生存结果较差。CP评分为7分的患者不良事件和肝硬化相关并发症的发生率与CP A级肝功能患者相同，这表明前者可纳入新药的临床试验。
We compared the efficacy and safety of sorafenib in patients with Child-Pugh (CP) class B and CP class A.Clinical data from 267 patients with HCC who had been treated with sorafenib were reviewed. Patients were grouped according to CP score (5-6, 7, and 8-9), and their tumor response, tolerance, and survival were assessed.Median patient age was 55 years, and 87.6% were men. Gender, HCC etiology, and extrahepatic metastasis did not differ according to CP score. Of the 225 evaluable patients, 4 achieved partial response and 121 achieved stable disease, making the disease control rate 46.8%. DCR was higher in patients with CP A than CP B score, but did not differ between those with CP scores of 7 and 8-9. The incidence rates of grade 3/4 toxicities did not differ according to CP score. Many patients with CP score 8-9 (26.3%) had to stop sorafenib due to cirrhosis-related complications. At a median follow-up of 15.6 months, the median time to progression and overall survival of all patients were 2.6 and 7.9 months, respectively. OS was greater in patients with CP score 5-6 than in patients with CP scores of 7 or 8-9.Sorafenib efficacy and survival outcomes were worse in patients with CP B function. Patients with a CP score of 7 had the same incidence of adverse events and cirrhosis-related complications as those with CP A liver function, suggesting that the former can be included in clinical trials of new agents.