Title |
Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial
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Published in |
Journal of Gastroenterology, August 2016
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DOI | 10.1007/s00535-016-1247-4 |
Pubmed ID | |
Authors |
Masatoshi Kudo, Etsuro Hatano, Shinichi Ohkawa, Hirofumi Fujii, Akihide Masumoto, Junji Furuse, Yoshiyuki Wada, Hiroshi Ishii, Shuntaro Obi, Shuichi Kaneko, Seiji Kawazoe, Osamu Yokosuka, Masafumi Ikeda, Katsuaki Ukai, Sojiro Morita, Akihito Tsuji, Toshihiro Kudo, Mitsuo Shimada, Yukio Osaki, Ryosuke Tateishi, Gen Sugiyama, Paolo Benjamin Abada, Ling Yang, Takuji Okusaka, Andrew Xiuxuan Zhu |
Abstract |
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. An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93). 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]. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 53 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Other | 10 | 19% |
Student > Master | 8 | 15% |
Researcher | 7 | 13% |
Student > Ph. D. Student | 6 | 11% |
Student > Bachelor | 5 | 9% |
Other | 8 | 15% |
Unknown | 9 | 17% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 23 | 43% |
Biochemistry, Genetics and Molecular Biology | 4 | 8% |
Nursing and Health Professions | 3 | 6% |
Agricultural and Biological Sciences | 3 | 6% |
Computer Science | 2 | 4% |
Other | 8 | 15% |
Unknown | 10 | 19% |