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Attend this session at the
2018 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Sunday June 3, 8:00 AM to 11:30 AM

Location: Hall A

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Discussion Session

Time: Sunday June 3, 4:45 PM to 6:00 PM

Location: Hall D2

Randomized, open label, multicenter, phase II trial of transcatheter arterial chemoembolization (TACE) therapy in combination with sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2018 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #206)

J Clin Oncol 36, 2018 (suppl; abstr 4017)

Author(s): Masatoshi Kudo, Kazuomi Ueshima, Takuji Torimura, Nobukazu Tanabe, Masafumi Ikeda, Hiroshi Aikata, Namiki Izumi, Takahiro Yamasaki, Shunsuke Nojiri, Keisuke Hino, Hidetaka Tsumura, Norio Isoda, Kohichiroh Yasui, Teiji Kuzuya, Takuji Okusaka, Junji Furuse, Norihiro Kokudo, Kiwamu Okita, Kenichi Yoshimura, Yasuaki Arai, TACTICS Trial Group; Department of Gastroenterology and Hepatology, Kindai University School of Medicine, Osaka, Japan; Kindai University, Osaka, Japan; Kurume University School of Medicine, Kurume, Japan; Sendai Medical Center, Sendai, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Hiroshima University Hospital, Hiroshima, Japan; Musashino Red Cross Hospital, Tokyo, Japan; Yamaguchi University Graduate School of Medicine, Ube, Japan; Nagoya University Graduate School of Medicine, Nagoya, Japan; Kawasaki Medical School, Okayama, Japan; Hyogo Cancer Center, Akashi, Japan; Jichi Medical University, Shimono, Japan; Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan; National Center for Global Health and Medicine, Tokyo, Japan; Shunan Memorial Hospital, Kudamatsu, Japan; Kyoto University Hospital, Kyoto, Japan; National Cancer Center, Tokyo, Japan

Abstract Disclosures


Background: There is no proven evidence that combination therapy of TACE with sorafenib (TS group) prolong progression-free survival (PFS) and/or overall survival (OS) compared to TACE alone (T group) in patients with unresectable HCC. Methods: In this randomized, open label, multicenter, comparative trial (NCT01217034), patients with unresectable HCC, Child-Pugh score ≤7, ECOG performance status 0-1, no vascular invasion (VI), no extrahepatic spread (EHS), size≤10 cm and number≤10 and adequate organ function were randomized 1:1 (stratification by institution, Milan criteria in or out, and number of previous TACE 0 or 1-2) to T or TS. In TS group, sorafenib 400 mg once daily was pretreated for 2-3 weeks prior to TACE followed by 800mg once daily during on-demand conventional TACE sessions until the time to unTACEable progression (TTUP), which was defined as the time to the date of a state when TACE continuation is not possible due to untreatable tumor progression, deterioration to Child-Pugh C or appearance of VI/EHS. Co-primary endpoints are PFS and OS. Multiplicity is adjusted using a gatekeeping hierarchical testing. PFS event in this trial was defined as death or time to TTUP. Key secondary endpoints were time to progression and safety. PFS is expected to 40% extension from 18 months (control arm) to 25 months, target HR was 0.71, with a power of 0.80. Results: The trial was conducted in 33 institutions and a total of 156 patients were randomized to T (n = 76) or TS (n = 80). Median PFS in the T group and TS group was 13.5 and 25.2 months (HR = 0.59, 95%CI 0.41-0.87; p = 0.006), respectively. The number of OS events has not reached. Median TTP was 13.5 and 24.1 months in the T and TS groups (HR = 0.56, 95%CI 0.38-0.83; p = 0.004). Median TTUP was 20.6 and 26.7 months in the T and TS groups (HR = 0.57, 95%CI 0.35-0.92; p = 0.02), respectively. There was no unexpected toxicity. Conclusions: Sorafenib in combination with TACE significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with the known safety profile with previous TACE combination trials. Clinical trial information: NCT01217034

Other Abstracts in this Sub-Category:


1. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib.

Meeting: 2018 ASCO Annual Meeting Abstract No: 4003 First Author: Andrew X. Zhu
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


2. Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer: A Japan Clinical Oncology Group study (JCOG1113, FUGA-BT).

Meeting: 2018 ASCO Annual Meeting Abstract No: 4014 First Author: Makoto Ueno
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


3. Outcomes of patients (pts) with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE): Global OPTIMIS final analysis.

Meeting: 2018 ASCO Annual Meeting Abstract No: 4018 First Author: Markus Peck-Radosavljevic
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer