背景:本研究旨在探讨索拉菲尼在治疗Child-Pugh评分为B级(CPB)的肝硬化患者中的有效性、耐受性以及生存获益。方法:对香港玛丽医院使用索拉菲尼治疗的晚期肝细胞癌患者进行回顾性分析。根据患者的Child-Pugh分级对其治疗结果进行评价。 Child-Pugh评分为B级的患者进一步分为CPB7 (Child-Pugh 评分为7) 和CPB8-9 (Child-Pugh 评分为8 或 9)两个亚组。结果:108例CPA和64例CPB的患者人口学基线特征匹配。CPA、CPB7和CPB8-9组,临床获益率(21.3% vs 32.4% vs 14.8%; P =0.23)和无进展生存期[均值(月): 3.2 vs 3.2 vs 2.3; P= 0.26]相似,三组间总体生存期存在差异(P =0.002),并在CPB患者中表现出预后较差的趋势;CPA, CPB7 和CPB8-9三组患者总体生存期均值分别为6.1, 5.4和 2.7个月。最为常见的3/4级不良反应是手足综合症(13.5%),腹泻(9.9%),和皮疹(7.0%)。3/4级不良反应:白细胞减少症、血小板减少症、贫血在这些病人中的发生率分别为2.9%, 5.3%和8.8%。总体来看,3组病人在出现大部分这些不良反应的概率相似,但CPB患者更易出现贫血(P=0.01),消化道出血(P=0.02),和肝性脑病(P=0.02)。结论:CPA 和CPB的患者对于索拉菲尼的耐受性,治疗后的临床获益及无进展生存期相似。在CPB病人中,child评分为7分的患者受益最大;然而,CPB病人更容易出现肝硬化并发症,因而需要更多警惕性的监视。
吉林大学第一医院肝胆胰内科 本文首次发表于[Cancer. 2012 Nov 1]
The Use of Single-Agent Sorafenib in the Treatment of Advanced Hepatocellular Carcinoma Patients With Underlying Child-Pugh B Liver Cirrhosis:A Retrospective Analysis of Efficacy, Safety, and Survival Benefits
BACKGROUND: This study explored the efficacy, tolerability, and survival benefits of using sorafenib in patients with Child-Pugh class B (CPB) cirrhosis. METHODS: Patients with advanced hepatocellular carcinoma who were treated with sorafenib at Queen Mary Hospital, Hong Kong, China, were analyzed retrospectively. Treatment outcomes were analyzed according to their respective Child-Pugh status. Patients with CPB disease were further divided into CPB7 (those with a score of 7) and CPB8-9 (a score of 8 or 9) subgroups. RESULTS: The baseline demographic parameters were comparable between 108 patients with Child-Pugh class A (CPA) disease and 64 CPB patients. Both clinical benefit rate (21.3% vs 32.4% vs 14.8%; P =0.23) and progression-free survival (median: 3.2 months vs 3.2 months vs 2.3 months; P =0.26) were similar among CPA, CPB7, and CPB8-9 groups, respectively. The overall survival was different among these groups (P =0.002) and showed a trend toward worse outcome in CPB patients: the median was 6.1, 5.4, and 2.7 months among CPA, CPB7, and CPB8-9 patients, respectively. The commonest grade 3/4 adverse events were hand-foot syndrome (13.5%), diarrhea (9.9%), and rash (7.0%). Grade 3/4 leukopenia, thrombocytopenia, and anemia occurred in 2.9%, 5.3%, and 8.8% of the patients, respectively. Overall, the 3 groups of patients experienced similar incidence of most of these adverse events. Nonetheless, CPB patients experienced more anemia (P=0.01), gastrointestinal bleeding (P=0.02), and hepatic encephalopathy (P=0.02). CONCLUSIONS: CPA and CPB patients tolerated sorafenib similarly and derived similar clinical and progression-free survival benefit. Among CPB patients, most benefits were observed in patients with a score of 7. Nevertheless, CPB patients were more susceptible to developing cirrhotic complications, and thus more vigilant surveillance is needed.
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