Efficacy and tolerability of bevacizumab plus capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.

Efficacy and tolerability of bevacizumab plus capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.
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贝伐珠单抗联合卡培他滨作为晚期肝细胞癌患者一线治疗的疗效和耐受性。

DOI:
10.1038/sj.bjc.6605580
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发表时间:
2010-03-16
影响因子:
8.8
通讯作者:
--
中科院分区:
医学1区
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--
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具有抗血管生成活性的分子靶向药物,包括贝伐单抗,已经在晚期/转移性肝细胞癌(HCC)患者中显示出临床活性。这项涉及几个亚洲国家患者的多中心II期研究试图评估贝伐单抗联合卡培他滨在这些人群中的安全性和有效性。经组织学证实/临床确诊的晚期肝癌患者,贝伐单抗7.5 mg kg-1,第1天;卡培他滨800 mg m-2,每3周2次,第1-14天,作为一线治疗。共纳入45例患者,44例(96%)有肝外转移和/或大血管侵犯,30例(67%)有乙肝,未发生3/4级血液学毒性。与治疗相关的3/4级非血液学毒性包括腹泻(n=2,4%)、恶心/呕吐(n=1,2%)、胃肠道出血(n=4,9%)和手足综合征(n=4,9%)。总有效率(RECIST)为9%,疾病控制率为52%。总体而言,中位无进展生存期(PFS)和总生存期(OS)分别为2.7个月和5.9个月。意大利方案(CLIP)评分⩽评分为3的患者的中位PFS和OS分别为3.6月和8.2月,CLIP评分为4的患者分别为1.4月和3.3月。贝伐单抗-卡培他滨联合用药在晚期肝癌患者中显示出良好的耐受性和适度的抗肿瘤活性。
Molecularly targeted agents with anti-angiogenic activity, including bevacizumab, have demonstrated clinical activity in patients with advanced/metastatic hepatocellular carcinoma (HCC). This multicentre phase II study involving patients from several Asian countries sought to evaluate the safety and efficacy of bevacizumab plus capecitabine in this population. Histologically proven/clinically diagnosed advanced HCC patients received bevacizumab 7.5 mg kg–1 on day 1 and capecitabine 800 mg m–2 twice daily on days 1–14 every 3 weeks as first-line therapy. A total of 45 patients were enrolled; 44 (96%) had extrahepatic metastasis and/or major vessel invasion and 30 (67%) had hepatitis B. No grade 3/4 haematological toxicity occurred. Treatment-related grade 3/4 non-haematological toxicities included diarrhoea (n=2, 4%), nausea/vomiting (n=1, 2%), gastrointestinal bleeding (n=4, 9%) and hand–foot syndrome (n=4, 9%). The overall response rate (RECIST) was 9% and the disease control rate was 52%. Overall, median progression-free survival (PFS) and overall survival (OS) were 2.7 and 5.9 months, respectively. Median PFS and OS were 3.6 and 8.2 months, respectively, for Cancer of the Liver Italian Programme (CLIP) score ⩽3 patients, and 1.4 and 3.3 months, respectively, for CLIP score 4 patients. The bevacizumab–capecitabine combination shows good tolerability and modest anti-tumour activity in patients with advanced HCC.
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