Sato Yozo, Nishiofuku Hideyuki, Yasumoto Taku, Nakatsuka Atsuhiro, Matsuo Kunihiro, Kodama Yoshihisa, Okubo Hironao, Abo Daisuke, Takaki Haruyuki, Inaba Yoshitaka, Yamakado Koichiro
Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan.
Department of Radiology, Nara Medical University, Kashihara, Japan.
J Vasc Interv Radiol. 2018 Aug;29(8):1061-1067. doi: 10.1016/j.jvir.2018.03.020. Epub 2018 Jun 20.
To evaluate safety and efficacy of combining sorafenib with transarterial chemoembolization in patients with advanced stage hepatocellular carcinomas (HCCs).
Systemic chemotherapy-naïve patients with a Child-Pugh class A liver profile and advanced stage HCCs were enrolled. Sorafenib therapy (daily dose 800 mg) was initiated within 4 weeks after initial conventional transarterial chemoembolization with an allowance of subsequent on-demand conventional chemoembolization. The primary endpoint was rate of protocol treatment completion, which was defined as sorafenib administration for at least 2 months. Secondary endpoints included objective response rate, disease control rate, overall survival, progression-free survival, and incidence of adverse events. Thirty-one patients (24 men, 7 women; median age, 75 years; vascular invasion, n = 19; extrahepatic metastases, n = 18; both, n = 6) who met the inclusion criteria were enrolled.
Protocol treatment was completed in 28 patients (90.3%, 28/31) with median protocol treatment duration of 7.0 months (range, 0.5-30 months) and median of 2 (range, 1-4) transarterial chemoembolization sessions. Objective response rate was 77.4% with median overall and progression-free survival of 17.3 months (95% confidence interval, 11.9-22.6 months) and 5.4 months (95% confidence interval, 4.6-6.2 months), respectively. The most common grade 3 or 4 adverse events were self-limiting elevation of aspartate aminotransferase (54.8%, 17/31) and alanine aminotransferase (45.2%, 14/31).
This combination therapy is feasible and promising in patients with advanced stage HCCs.
评估索拉非尼联合经动脉化疗栓塞术治疗晚期肝细胞癌（HCC）患者的安全性和疗效。
纳入未接受过全身化疗、肝功能为Child-Pugh A级且为晚期HCC的患者。在首次常规经动脉化疗栓塞术后4周内开始索拉非尼治疗（每日剂量800mg），后续可根据需要进行常规化疗栓塞。主要终点为方案治疗完成率，定义为索拉非尼给药至少2个月。次要终点包括客观缓解率、疾病控制率、总生存期、无进展生存期和不良事件发生率。31例符合纳入标准的患者（24例男性，7例女性；中位年龄75岁；血管侵犯19例；肝外转移18例；两者皆有6例）入组。
28例患者（90.3%，28/31）完成了方案治疗，中位方案治疗持续时间为7.0个月（范围0.5 - 30个月），中位经动脉化疗栓塞次数为2次（范围1 - 4次）。客观缓解率为77.4%，中位总生存期和无进展生存期分别为17.3个月（95%置信区间，11.9 - 22.6个月）和5.4个月（95%置信区间，4.6 - 6.2个月）。最常见的3级或4级不良事件为自限性的天冬氨酸转氨酶升高（54.8%，17/31）和丙氨酸转氨酶升高（45.2%，14/31）。
这种联合治疗对晚期HCC患者是可行且有前景的。
