Sorafenib in combination with transarterial chemoembolization in Chinese patients with hepatocellular carcinoma: a subgroup interim analysis of the START trial
Sorafenib in combination with transarterial chemoembolization in Chinese patients with hepatocellular carcinoma: a subgroup interim analysis of the START trial
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DOI：
10.2217/fon.13.11
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发表时间：
2013-03-01
期刊：
影响因子：
3.3
通讯作者：
Wang, Jianhua
中科院分区：
文献类型：
--
作者：
Han, Guohong;Yang, Jijin;Wang, Jianhua
START试验的第三个中期结果显示了令人鼓舞的安全性和有效性，中位进展时间为9个月。该亚组分析提供了入组START试验的中国患者的结果。材料和方法：62例患有不可切除肝细胞癌的中国患者（中位年龄52岁）使用碘油（R）（加栢，巴黎，法国）和多柔比星（30-60 mg）乳剂进行经动脉化疗栓塞（TACE），然后使用可吸收颗粒进行栓塞。索拉非尼（400 mg，每日两次）在TACE手术前后4天连续给药，有剂量假期。每6-8周进行一次TACE，4-6周后评估缓解，如果没有进一步TACE的指征，则每3个月评估一次。患者继续接受索拉非尼治疗，直至出现疾病进展或不可接受的毒性。结果：37例（59.68%）患者接受了不超过2次TACE手术。索拉非尼治疗期间（中位持续时间6.4个月;平均日剂量787.6 mg），75.8%的患者发生不良事件，最常见的是发热（37.1%）、腹泻（27.4%）、皮肤反应（22.6%）、脱发（19.4%）和肝功能异常（16.1%）。最常见的3-4级不良事件为肝功能异常（6.5%）和腹泻（3.2%）。中位至进展时间和总生存期分别为10.6和16.5个月，客观缓解率和疾病稳定率分别为44.3%和42.6%。结论：TACE联合索拉非尼治疗中国不能切除的肝癌患者安全有效。
Aim: The third interim results of the START trial showed encouraging safety and efficacy profiles, with a median time to progression of 9 months. This subgroup analysis presents results in Chinese patients enrolled in the START trial. Materials & methods: Sixty two Chinese patients (median age 52 years) with unresectable hepatocellular carcinoma had transarterial chemoembolization (TACE) performed with an emulsion of Lipiodol (R) (Guerbet, Paris, France) and doxorubicin (30-60 mg) followed by embolization with absorbable particles. Sorafenib (400 mg twice-daily) was administered continuously with dose holidays 4 days prior to and post TACE procedures. TACE was performed every 6-8 weeks and responses were assessed after 4-6 weeks and then every 3 months if no further TACE was indicated. Patients continued receiving sorafenib until disease progression or unacceptable toxicity occurred. Results: Thirty seven patients (59.68%) received no more than two TACE procedures. During sorafenib treatment (median duration 6.4 months; mean daily dose 787.6 mg), 75.8% of patients experienced adverse events, most commonly pyrexia (37.1%), diarrhea (27.4%), skin reactions (22.6%), alopecia (19.4%) and abnormal hepatic function (16.1%). The most common grade 3-4 adverse events were abnormal hepatic function (6.5%) and diarrhea (3.2%). The median time to progression and overall survival were 10.6 and 16.5 months, respectively, and the objective response and stable disease rates were 44.3 and 42.6%, respectively. Conclusion: The combination of the TACE and sorafenib proved both safe and effective in the treatment of Chinese patients with unresectable hepatocellular carcinoma.