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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 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).

Sub-category:
Hepatobiliary Cancer

Category:
Gastrointestinal (Noncolorectal) Cancer

Meeting:
2018 ASCO Annual Meeting

Abstract No:
4014

Poster Board Number:
Poster Discussion Session (Board #203)

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 4014)

Author(s): Makoto Ueno, Chigusa Morizane, Takuji Okusaka, Junki Mizusawa, Hiroshi Katayama, Masafumi Ikeda, Masato Ozaka, Kazuya Sugimori, Akira Fukutomi, Hiroki Hara, Nobumasa Mizuno, Hiroaki Yanagimoto, Keiji Sano, Kazutoshi Tobimatsu, Kei Yane, Shoji Nakamori, Naohiro Sata, Seigo Yukisawa, Hiroshi Ishii, Junji Furuse; Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama, Japan; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan; JCOG Data Center/ Operation Office, National Cancer Center Hospital, Tokyo, Japan; JCOG Data Center/ Operation Office, National Cancer Center, Tokyo, Japan; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan; Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan; Divison of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan; Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan; Department of Surgery, Kansai Medical University Hirakata Hospital, Hirakata, Japan; Teikyo University School of Medicine, Tokyo, Japan; Kobe University Graduate School of Medicine, Kobe, Japan; Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan; Department of Hepato-Biliary-Pancreatic Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan; Department of Surgery, Jichi Medical University School of Medicine, Shimotsuke, Japan; Tochigi Cancer Center, Utsunomiya, Japan; Clinical Research Center, Shizuoka Cancer Center, Matsuyama, Japan; Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan

Abstract Disclosures

Abstract:

Background: Gemcitabine (GEM) plus cisplatin (GC) is the standard of care for advanced biliary tract cancer (BTC). However, GC is considered to be toxic because of nausea, vomiting, and appetite loss, and inconvenient due to requiring hydration before and after administration. GEM plus S-1 (GS) was reported to be promising with preferable efficacy and acceptable toxicity profile. This phase III study aimed to confirm the non-inferiority of GS to GC in terms of overall survival (OS). Methods: Eligibility criteria included chemotherapy-naïve patients with recurrent or unresectable biliary tract adenocarcinoma (gallbladder, intrahepatic biliary tract, extrahepatic biliary tract, or ampulla of Vater), an ECOG-PS of 0–1, and adequate organ function. In the GC arm, 1 g/m2 of GEM and 25 mg/m2 of cisplatin was infused on days 1 and 8 of a 21-day cycle. In the GS arm, 1 g/m2 of GEM was infused on days 1 and 8, and S-1 60, 80, or 100 mg/day according to body-surface area was administered from days 1 to 14 of a 21-day cycle. The primary endpoint was OS and the secondary endpoints included progression-free survival (PFS), response rate (RR), adverse events (AEs), clinically relevant AEs predefined as any of grade 2 or more fatigue, appetite loss, nausea, vomiting, oral mucositis, and diarrhea. The sample size was calculated to be 350 with a one-sided alpha of 5%, a power of 80%, non-inferiority margin of 1.155 in terms of hazard ratio (HR). Results: From May 2013 to March 2016, 354 patients were enrolled. The non-inferiority of GS to GC was demonstrated (median OS: 13.4 months (m) in GC and 15.1 m in GS, HR 0.95; 90% confidence interval (CI), 0.78 to 1.15; P = 0.046 for non-inferiority). Median PFS was 5.8 m in GC and 6.8 m in GS (HR 0.86, 95% CI, 0.70-1.07). RR was 32.4% in GC and 29.8% in GS. Both treatments were generally well tolerated. Clinically relevant AEs were observed 35.1% in GC and 29.9 % in GS. Conclusions: GS demonstrated non-inferiority to GC in OS with good tolerability and was considered as new convenient option of standard of care without hydration for advanced BTC. Clinical trial information: UMIN000010667.

 
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, 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.

Meeting: 2018 ASCO Annual Meeting Abstract No: 4017 First Author: Masatoshi Kudo
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

 

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