Xijing Hospital, the Fourth Military Medical University, Xi'an, China.
Future Oncol. 2013 Mar;9(3):403-10. doi: 10.2217/fon.13.11.
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(®) (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.
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.
The combination of the TACE and sorafenib proved both safe and effective in the treatment of Chinese patients with unresectable hepatocellular carcinoma.
START 试验的第三次中期结果显示出令人鼓舞的安全性和疗效，无进展中位时间为 9 个月。本亚组分析介绍了 START 试验中入组的中国患者的结果。
62 例不能切除的肝细胞癌患者（中位年龄 52 岁）接受了载药微球栓塞化疗（TACE），化疗药物使用的是碘油（®）（法国盖尔贝公司）和阿霉素（30-60mg），随后用可吸收颗粒进行栓塞。索拉非尼（400mg，每日两次）连续给药，在 TACE 术前和术后 4 天有 4 天的停药期。TACE 每 6-8 周进行一次，在 4-6 周后评估反应，如果没有进一步的 TACE 指征，则每 3 个月评估一次。患者继续接受索拉非尼治疗，直到疾病进展或出现不可接受的毒性。
37 例患者（59.68%）接受的 TACE 治疗不超过 2 次。在索拉非尼治疗期间（中位持续时间 6.4 个月；平均日剂量 787.6mg），75.8%的患者出现不良反应，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 级不良反应是肝功能异常（6.5%）和腹泻（3.2%）。中位无进展生存期和总生存期分别为 10.6 个月和 16.5 个月，客观缓解率和疾病稳定率分别为 44.3%和 42.6%。
TACE 联合索拉非尼治疗不能切除的肝细胞癌的中国患者，既安全又有效。
