Department of Oncology, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei, Taiwan.
Br J Cancer. 2010 Mar 16;102(6):981-6. doi: 10.1038/sj.bjc.6605580. Epub 2010 Feb 16.
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 < or =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.
具有抗血管生成活性的分子靶向药物，包括贝伐单抗，已在晚期/转移性肝细胞癌（HCC）患者中显示出临床活性。这项涉及多个亚洲国家患者的多中心 II 期研究旨在评估贝伐单抗联合卡培他滨在该人群中的安全性和疗效。
组织学证实/临床诊断为晚期 HCC 的患者接受贝伐单抗 7.5 mg/kg 于第 1 天，卡培他滨 800 mg/m² 每天 2 次于第 1-14 天，每 3 周为一线治疗。
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%）有乙型肝炎。未发生 3/4 级血液学毒性。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%）。根据 RECIST 标准，总缓解率（ORR）为 9%，疾病控制率为 52%。总体而言，无进展生存期（PFS）和总生存期（OS）的中位数分别为 2.7 和 5.9 个月。对于癌症分期评分（CLIP）<或=3 分的患者，中位 PFS 和 OS 分别为 3.6 和 8.2 个月，而对于 CLIP 评分 4 分的患者，分别为 1.4 和 3.3 个月。
贝伐单抗联合卡培他滨在晚期 HCC 患者中具有良好的耐受性和适度的抗肿瘤活性。
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