肝癌患者经动脉化疗栓塞（TACE）加索拉非尼与单独使用TACE的

StephenW

Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial

    Masatoshi Kudo1, Kazuomi Ueshima1, Masafumi Ikeda2, Takuji Torimura3, Nobukazu Tanabe4, Hiroshi Aikata5, Namiki Izumi6, Takahiro Yamasaki7, Shunsuke Nojiri8, Keisuke Hino9, Hidetaka Tsumura10, Teiji Kuzuya11, Norio Isoda12, Kohichiroh Yasui13, Hajime Aino14, Akio Ido15, Naoto Kawabe16, Kazuhiko Nakao17, Yoshiyuki Wada18, Osamu Yokosuka19, Kenichi Yoshimura20, Takuji Okusaka21, Junji Furuse22, Norihiro Kokudo23, Kiwamu Okita24, Philip James Johnson25, Yasuaki Arai26 on behalf of the TACTICS study group

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Abstract

Objective This trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE.

Design Patients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination 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 (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing.

Results Median PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities.

Conclusion TACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials.

Trial registration number NCT01217034.

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http://dx.doi.org/10.1136/gutjnl-2019-318934

StephenW

肝癌患者经动脉化疗栓塞（TACE）加索拉非尼与单独使用TACE的随机，多中心前瞻性试验：TACTICS试验

    工藤正敏1，上岛一雄1，池田正史2，池田隆二3，田边信夫4，田中宏5，南木泉6，山高隆7，野中俊介8，圭野圭介9，中村秀隆10，中次康久矢也11，香户弘大14， ，TACTICS研究小组的代表，中尾和彦17，和田佳行18，横须修（Osamu Yokosuka）19，吉村健一（Kenichi Yoshimura）20，高冈隆司（Takuji Okusaka）21，准二古濑（Fujiuse）22，国广典弘（Norihiro Kokudo）23，冈田喜和（Kiwamu Okita）24，菲利普·詹姆斯·约翰逊（25）

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目的该研究比较了新建立的TACE特异性终点和在初始TACE之前对索拉非尼进行预处理的经动脉化疗栓塞（TACE）加索拉非尼与单独使用TACE的疗效和安全性。

设计将无法切除的肝细胞癌（HCC）患者随机分为TACE加索拉非尼（n = 80）或单独使用TACE（n = 76）。联合治疗组的患者在TACE前2至3周每天接受400毫克索拉非尼治疗，随后在常规TACE疗程中每天接受800毫克mg索拉非尼治疗，直至达到无法治疗的（不可治疗的）进展时间（TTUP），即定义为不可治疗的肿瘤进展， Child-Pugh C暂时性恶化或出现血管浸润/肝内扩散。共同主要终点是无进展生存期（PFS），这不是常规的生存期，而是定义为TTUP，即达到任何死亡原因的时间加总生存期（OS）。通过关守分级测试调整了多样性。

结果TACE加索拉非尼组的中位PFS明显长于单独TACE组（25.2 vs 13.5个月； p = 0.006）。未分析OS，因为仅达到73.6％的OS事件。 TACE加索拉非尼组的中位TTUP（26.7 vs 20.6个月； p = 0.02）也明显更长。 TACE加索拉非尼组和单独的TACE组在1年和2年时的OS分别为96.2％和82.7％，77.2％和64.6％。没有意外的毒性。

结论TACE加索拉非尼在不能切除的HCC患者中的PFS明显高于单纯TACE。不良事件与之前的TACE联合试验一致。

试用注册号NCT01217034。

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http://dx.doi.org/10.1136/gutjnl-2019-318934

StephenW

https://gut.bmj.com/content/earl ... p;utm_term=08122019