教員業績データベース |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読なし |
表題 | Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial |
掲載誌名 | 正式名:Journal of gastroenterology 略 称:J Gastroenterol ISSNコード:1435-5922(Electronic)0944-1174(Linking) |
掲載区分 | 国外 |
巻・号・頁 | 52(4),pp.494-503 |
著者・共著者 | Kudo Masatoshi, Hatano Etsuro, Ohkawa Shinichi, Fujii Hirofumi, Masumoto Akihide, Furuse Junji, Wada Yoshiyuki, Ishii Hiroshi, Obi Shuntaro, Kaneko Shuichi, Kawazoe Seiji, Yokosuka Osamu, Ikeda Masafumi, Ukai Katsuaki, Morita Sojiro, Tsuji Akihito, Kudo Toshihiro, Shimada Mitsuo, Osaki Yukio, Tateishi Ryosuke, Sugiyama Gen, Abada Paolo Benjamin, Yang Ling, Okusaka Takuji, Zhu Andrew Xiuxuan |
発行年月 | 2017/04 |
概要 | BACKGROUND:REACH evaluated ramucirumab in the second-line treatment of patients with advanced hepatocellular carcinoma. In the intent-to-treat population (n = 565), a significant improvement in overall survival (OS) was not observed. In patients with an elevated baseline α-fetoprotein (AFP) level (400 ng/mL or greater), an improvement in OS was demonstrated. An analysis of the Japanese patients in REACH was performed.METHODS:An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93).RESULTS:The median OS was 12.9 months for the ramucirumab arm (n = 45) and 8.0 months for the placebo arm (n = 48) [hazard ratio (HR) 0.621 (95 % confidence interval (CI) 0.391-0.986); P = 0.0416]. The median progression-free survival was 4.1 months for the ramucirumab arm and 1.7 months for the placebo arm [HR 0.449 (95 % CI 0.285-0.706); P = 0.0004]. The objective response rates were 11 % for the ramucirumab arm and 2 % for the placebo arm (P = 0.0817). The grade 3 or higher treatment-emergent adverse events occurring in more than 5 % of patients with a higher incidence for the ramucirumab arm (n = 44) than for the placebo arm (n = 47) were ascites (7% vs 2 %), hypertension (7 % vs 2 %), and cholangitis (7 % vs 0 %). In patients with a baseline AFP level of 400 ng/mL or greater, the median OS was 12.9 months for the ramucirumab arm (n = 20) and 4.3 months for the placebo arm (n = 22) [HR 0.464 (95 % CI 0.232-0.926); P = 0.0263].CONCLUSIONS:In the Japanese patients in REACH, ramucirumab treatment improved OS, including in patients with a baseline AFP level of 400 ng/mL or greater; improvements in progression-free survival and objective response rate were also demonstrated. The safety profile of ramucirumab was acceptable and well tolerated in Japanese patients. ClinicalTrials.gov identifier NCT01140347. |
DOI | 10.1007/s00535-016-1247-4 |
PMID | 27549242 |