Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial

医学 吉西他滨 恶心 内科学 粘膜炎 危险系数 呕吐 胃肠病学 不利影响 临床终点 临床研究阶段 置信区间 化疗 外科 肿瘤科 随机对照试验
作者
Chigusa Morizane,Takuji Okusaka,Junki Mizusawa,Hiroshi Katayama,Makoto Ueno,Masafumi Ikeda,Masato Ozaka,Naohiro Okano,Kazuya Sugimori,Akira Fukutomi,Hiroki Hara,Nobumasa Mizuno,Hiroaki Yanagimoto,Keita Wada,Kazutoshi Tobimatsu,Kei Yane,Shoji Nakamori,Hiroyuki Yamaguchi,Akinori Asagi,Seigo Yukisawa,Yasushi Kojima,Ken Kawabe,Yasuyuki Kawamoto,Rie Sugimoto,Tomohisa Iwai,Kazuyoshi Nakamura,Hiroyoshi Miyakawa,Tatsuya Yamashita,A. Hosokawa,Tatsuya Ioka,Naoya Kato,Kazuhiko Shioji,Kyoko Shimizu,Toshio Nakagohri,Ken Kamata,Hiroshi Ishii,Junji Furuse
出处
期刊:Annals of Oncology [Elsevier BV]
卷期号:30 (12): 1950-1958 被引量:248
标识
DOI:10.1093/annonc/mdz402
摘要

BackgroundGemcitabine plus cisplatin (GC) is the standard treatment of advanced biliary tract cancer (BTC); however, it causes nausea, vomiting, and anorexia, and requires hydration. Gemcitabine plus S-1 (GS) reportedly has equal to, or better, efficacy and an acceptable toxicity profile. We aimed to confirm the non-inferiority of GS to GC for patients with advanced/recurrent BTC in terms of overall survival (OS).Patients and methodsWe undertook a phase III randomized trial in 33 institutions in Japan. Eligibility criteria included chemotherapy-naïve patients with recurrent or unresectable BTC, an Eastern Cooperative Oncology Group Performance Status of 0 − 1, and adequate organ function. The calculated sample size was 350 with a one-sided α of 5%, a power of 80%, and non-inferiority margin hazard ratio (HR) of 1.155. The primary end point was OS, while the secondary end points included progression-free survival (PFS), response rate (RR), adverse events (AEs), and clinically significant AEs defined as grade ≥2 fatigue, anorexia, nausea, vomiting, oral mucositis, or diarrhea.ResultsBetween May 2013 and March 2016, 354 patients were enrolled. GS was found to be non-inferior to GC [median OS: 13.4 months with GC and 15.1 months with GS, HR, 0.945; 90% confidence interval (CI), 0.78–1.15; P = 0.046 for non-inferiority]. The median PFS was 5.8 months with GC and 6.8 months with GS (HR 0.86; 95% CI 0.70–1.07). The RR was 32.4% with GC and 29.8% with GS. Both treatments were generally well-tolerated. Clinically significant AEs were observed in 35.1% of patients in the GC arm and 29.9% in the GS arm.ConclusionsGS, which does not require hydration, should be considered a new, convenient standard of care option for patients with advanced/recurrent BTC.Clinical Trial numberThis trial has been registered with the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm), number UMIN000010667.
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