GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis.
GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis.
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DOI：
10.1111/ijcp.12352
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发表时间：
2014-05
影响因子：
2.6
通讯作者：
Sanyal AJ
中科院分区：
文献类型：
--
作者：
Lencioni R;Kudo M;Ye SL;Bronowicki JP;Chen XP;Dagher L;Furuse J;Geschwind JF;de Guevara LL;Papandreou C;Takayama T;Yoon SK;Nakajima K;Lehr R;Heldner S;Sanyal AJ
GIDEON （Global Investigation of therapeutic DEcisions in hepatellular carcinoma [HCC] and of the treatment with sorafeNib）是一项全球性、前瞻性、非干预性研究，旨在评估索拉非尼在现实生活中治疗不可切除HCC患者的安全性，包括被排除在临床试验之外的Child-Pugh B患者。不可切除的HCC患者，其医生根据批准的标签和处方指南决定使用索拉非尼治疗，符合纳入条件。入境时记录人口统计数据和疾病/病史。随访时收集索拉非尼剂量和不良事件（ae）。第二次中期分析对约1500名接受治疗的患者进行了≥4个月的随访。在1571例可评估安全性的患者中，61%为Child-Pugh A状态，23%为Child-Pugh b状态，大多数患者（74%）接受了批准的800 mg索拉非尼初始剂量，无论Child-Pugh状态如何；然而，Child-Pugh B患者的中位治疗时间较短。大多数药物相关不良事件为1级或2级，最常见的报告与以前的报告一致。在Child-Pugh、巴塞罗那临床肝癌（BCLC）和初始给药亚组中，药物相关不良事件的发生率和性质大致相似，并且与总体人群一致。与第一次中期分析一致，Child-Pugh亚组的总体安全性和给药策略相似。无论索拉非尼初始剂量或BCLC分期如何，安全性研究结果也具有可比性。目前正在对3000名患者进行最终分析。
GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials. Patients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ∼1500 treated patients were followed up for ≥ 4 months. Of the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population. Consistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.
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影响因子：
29.4
作者：
El-Serag HB
通讯作者：
El-Serag HB
DOI：
10.1111/j.1742-1241.2010.02414.x
发表时间：
2010-07-01
影响因子：
2.6
作者：
Lencioni, R.;Marrero, J.;Kudo, M.
通讯作者：
Kudo, M.
DOI：
10.1111/j.1478-3231.2008.01957.x
发表时间：
2009-04
期刊：
Liver international : official journal of the International Association for the Study of the Liver
影响因子：
--
作者：
Tandon P;Garcia-Tsao G
通讯作者：
Garcia-Tsao G
影响因子：
158.5
作者：
Llovet, Josep M.;Ricci, Sergio;Bruix, Jordi
通讯作者：
Bruix, Jordi
索拉非尼对亚太地区晚期肝细胞癌患者的疗效和安全性：一项 III 期随机、双盲、安慰剂对照试验
影响因子：
51.1
作者：
Cheng, Ann-Lii;Kang, Yoon-Koo;Guan, Zhongzhen
通讯作者：
Guan, Zhongzhen