From Vascular and Interventional Radiology, Johns Hopkins University School of Medicine, 600 N Wolfe St, Blalock 545, Baltimore, MD 21287 (J.F.G.); Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan (M.K.); Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, Tex (J.A.M.); University of California-San Francisco, San Francisco, Calif (A.P.V.); Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (X.P.C.); Department of Gastroenterology and Hepatology, INSERM U954, University Hospital, University of Lorraine, Nancy, France (J.P.B.); Policlínica Metropolitana, Caracas, Venezuela (L.D.); Kyorin University School of Medicine, Mitaka, Tokyo, Japan (J.F.); Hospital Angeles Clínica Londres, Mexico City, Mexico (L.L.d.G.); University Hospital of Larissa, Larissa, Greece (C.P.); Virginia Commonwealth University Medical Center, Richmond, Va (A.J.S.); Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan (T.T.); Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China (S.L.Y.); The Catholic University of Korea, Seoul, Korea (S.K.Y.); Global Medical Affairs, Bayer Healthcare Pharmaceuticals, Whippany, NJ (K.N.); Clinical Statistics, Bayer Healthcare Pharmaceuticals, Whippany, NJ (R.L.); Global Medical Affairs and Pharmacovigilance, Bayer Pharma AG, Berlin, Germany (S.H.); and Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy (R.L.).
Radiology. 2016 May;279(2):630-40. doi: 10.1148/radiol.2015150667. Epub 2016 Jan 8.
To evaluate transarterial chemoembolization (TACE) use prior to and concomitantly with sorafenib in patients with unresectable hepatocellular carcinoma (HCC) across different global regions.
GIDEON is an observational registry study of more than 3000 HCC patients. Patients with histologically, cytologically, or radiographically diagnosed HCC, and for whom a decision had been made to treat with sorafenib, were eligible. Patients were enrolled into the registry from 39 countries beginning in January 2009, with the last patient follow-up in April 2012. Detailed data on treatment history, treatment patterns, adverse events, and outcomes were collected. All treatment decisions were at the discretion of the treating physicians. Documented approval from local ethics committees was obtained, and all patients provided signed informed consent. Descriptive statistics, including minimum, median, and maximum, were calculated for metric data, and frequency tables for categorical data. Kaplan-Meier estimates with 95% confidence intervals were calculated for survival end points.
A total of 3202 patients were eligible for safety analysis, of whom 2631 (82.2%) were male. Median age was 62 years (range, 15-98 years). A total of 1511 (47.2%) patients underwent TACE prior to sorafenib; 325 (10.1%) underwent TACE concomitantly. TACE prior to sorafenib was more common in Japan and Asia-Pacific compared with all other regions (362 [71.3%] and 560 [60.3%] vs 12-209 [13.3%-37.1%]). Adverse events were reported in 2732 (85.3%) patients overall, with no notable differences in the incidence of adverse events, regardless of TACE treatment history. Overall survival was 12.7 months in prior-TACE patients, 9.2 months in non-prior-TACE patients, 21.6 months in concomitant-TACE patients, and 9.7 months in non-concomitant-TACE patients.
Global variation exists in TACE use in sorafenib-treated HCC patients. The combination of TACE with sorafenib appears to be a well-tolerated and viable therapeutic approach.
评估在不同全球区域内无法切除的肝细胞癌（HCC）患者中，在索拉非尼治疗前和同时进行经动脉化疗栓塞（TACE）的效果。
GIDEON 是一项针对 3000 多名 HCC 患者的观察性注册研究。符合组织学、细胞学或影像学诊断为 HCC 且已决定用索拉非尼治疗的患者符合入组条件。该研究于 2009 年 1 月开始在 39 个国家招募患者，最后一次患者随访时间为 2012 年 4 月。收集了详细的治疗史、治疗模式、不良事件和结局数据。所有治疗决策均由治疗医生决定。获得了当地伦理委员会的书面批准，所有患者均签署了知情同意书。对计量数据计算了最小值、中位数和最大值，对分类数据计算了频数表。计算了生存终点的 Kaplan-Meier 估计值及其 95%置信区间。
共有 3202 名患者符合安全性分析的条件，其中 2631 名（82.2%）为男性。中位年龄为 62 岁（范围：15-98 岁）。共有 1511 名（47.2%）患者在接受索拉非尼治疗前接受了 TACE；325 名（10.1%）患者同时接受了 TACE。与所有其他区域相比，日本和亚太地区在索拉非尼治疗前接受 TACE 的患者更多（分别为 362 例[71.3%]和 560 例[60.3%]与 12-209 例[13.3%-37.1%]）。总体而言，3232 名（85.3%）患者报告了不良事件，但无论 TACE 治疗史如何，不良事件的发生率均无显著差异。在接受 TACE 治疗的患者中，总体生存率为 12.7 个月，未接受 TACE 治疗的患者为 9.2 个月，同时接受 TACE 治疗的患者为 21.6 个月，未同时接受 TACE 治疗的患者为 9.7 个月。
在接受索拉非尼治疗的 HCC 患者中，TACE 的使用存在全球差异。TACE 联合索拉非尼似乎是一种耐受良好且可行的治疗方法。
