Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma

索拉非尼 医学 肝细胞癌 危险系数 内科学 实体瘤疗效评价标准 肝癌 肿瘤科 经导管动脉化疗栓塞 胃肠病学 随机对照试验 随机化 置信区间 肝功能 进行性疾病 化疗
作者
Masatoshi Kudo,Kazuomi Ueshima,Masafumi Ikeda,Takuji Torimura,Nobukazu Tanabe,Hiroshi Aikata,Namiki Izumi,Takahiro Yamasaki,Shunsuke Nojiri,Keisuke Hino,Hidetaka Tsumura,Teiji Kuzuya,Norio Isoda,Michihisa Moriguchi,Hajime Aino,Akio Ido,Naoto Kawabe,Kazuhiko Nakao,Yoshiyuki Wada,Sadahisa Ogasawara,Kenichi Yoshimura,Takuji Okusaka,Junji Furuse,Norihiro Kokudo,Kiwamu Okita,Philip J. Johnson,Yasuaki Arai
出处
期刊:Liver cancer [Karger Publishers]
卷期号:11 (4): 354-367 被引量:72
标识
DOI:10.1159/000522547
摘要

<b><i>Introduction:</i></b> Several clinical trials comparing the efficacy and safety of transarterial chemoembolization (TACE) plus molecular-targeted agents versus TACE alone revealed no clinical benefits in progression-free survival (PFS) or overall survival (OS). Here, we report the final OS analysis from the TACTICS trial, which previously demonstrated significant improvement in PFS with TACE plus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) (NCT01217034). <b><i>Methods:</i></b> Patients with unresectable HCC were randomized to a TACE plus sorafenib group (<i>N</i> = 80) or a TACE alone group (<i>N</i> = 76). Patients in the combination treatment group received sorafenib 400 mg once daily for 2–3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable progression. In this trial, TACE-specific PFS was used. TACE-specific PFS is defined as the time from randomization to progressive disease (PD) or death from any cause, and PD was defined as untreatable progression, caused by the inability of a patient to further receive or benefit from TACE for reasons that include intrahepatic tumor progression (25% increase vs. baseline) according to response evaluation criteria in cancer of the liver, the detection of extrahepatic spread, vascular invasion, or transient deterioration of liver function to Child-Pugh C after TACE. <b><i>Results:</i></b> At the cut-off date of July 31, 2020, 131 OS events were observed. The median OS was 36.2 months with TACE plus sorafenib and 30.8 months with TACE alone (hazard ratio [HR] = 0.861; 95% confidence interval [CI], 0.607–1.223; <i>p</i> = 0.40, ΔOS, 5.4 months). The updated PFS was 22.8 months with TACE plus sorafenib and 13.5 months with TACE alone (HR = 0.661; 95% CI, 0.466–0.938; <i>p</i> = 0.02). Post-trial treatments with active procedures/agents were received by 47 (58.8%) patients in the TACE plus sorafenib group and 58 (76.3%) in the TACE alone group (<i>p</i> = 0.01). In post hoc analysis, PFS and OS benefit were shown in HCC patients with tumor burden beyond up-to-7 criteria. <b><i>Conclusions:</i></b> In TACTICS trial, TACE plus sorafenib did not show significant OS benefit over TACE alone; however, clinical meaningful OS prolongation and significantly improved PFS was observed. Thus, the TACE plus sorafenib can be considered a choice of treatment in intermediate-stage HCC, especially in patients with high tumor burden. Trial Registration: NCT01217034.
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