Supplementary Material for: Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma: US Regional Analysis of the GIDEON Registry

Background: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Treatment with Sorafenib (GIDEON) is a worldwide, prospective, non-interventional study to evaluate the safety of sorafenib in a variety of patient subsets. Methods: Eligible patients had unresectable hepatocellular carcinoma for whom the decision had been made to treat with sorafenib. Treatment strategies were instituted at the physician's discretion. Patient and disease characteristics, treatment practices, incidences of adverse events (AEs), and overall survival were collected. Results: In the United States, 563 patients were evaluable for safety. Subgroup analysis was performed for patients who underwent transarterial chemoembolization (TACE) prior to the initiation of sorafenib (group A, n=158), after the initiation of sorafenib only (group B, n=29), both (group C, n=38), or did not undergo TACE (n=318). Patient demographics were similar across the groups. In group A, 29% had Child-Pugh score B or C at diagnosis, and 19% had Barcelona Clinic Liver Cancer tumor stage C or D. In group B, 48% had Child-Pugh score B or C at study entry, and 31% had BCLC stage C or D. The majority of patients in all groups initially received full-dose sorafenib. Incidences of grade ≥3 drug-related AEs were 30%, 17%, and 16% in groups A, B, and C, respectively, and 22% in patients who did not undergo TACE. No new safety signals emerged. Conclusions: The results from GIDEON reaffirm that sorafenib can be safely used in the context of TACE.

背景：全球肝细胞癌治疗决策及索拉非尼治疗研究（Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Treatment with Sorafenib, GIDEON）是一项全球性、前瞻性、非干预性研究，旨在评估索拉非尼在多种患者亚组中的安全性。
方法：入组患者均为经临床决策确认需接受索拉非尼治疗的不可切除肝细胞癌患者。治疗方案由主治医师自主制定。本研究收集了患者及疾病特征、临床诊疗行为、不良事件（adverse events, AEs）发生率以及总生存期数据。
结果：美国地区共纳入563例可进行安全性评估的患者。针对以下患者亚组开展亚组分析：索拉非尼启动治疗前接受经动脉化疗栓塞（transarterial chemoembolization, TACE）者（A组，n=158）、仅在索拉非尼启动治疗后接受TACE者（B组，n=29）、两个阶段均接受TACE者（C组，n=38）以及未接受TACE者（n=318）。各组患者的人口学特征均衡可比。A组中，29%的患者在确诊时Child-Pugh分级为B或C级，19%的患者巴塞罗那临床肝癌（Barcelona Clinic Liver Cancer, BCLC）分期为C或D期。B组中，48%的患者在研究入组时Child-Pugh分级为B或C级，31%的患者BCLC分期为C或D期。所有组中绝大多数患者初始治疗均采用索拉非尼全剂量方案。A、B、C组中≥3级药物相关不良事件的发生率分别为30%、17%、16%，未接受TACE的患者中该发生率为22%。未发现新的安全性信号。
结论：GIDEON研究结果再次证实，索拉非尼可安全应用于经TACE治疗后的患者人群。