Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-04

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

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. More... »

PAGES

494-503

References to SciGraph publications

  • 2011-05. HCC and angiogenesis: possible targets and future directions in NATURE REVIEWS CLINICAL ONCOLOGY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00535-016-1247-4

    DOI

    http://dx.doi.org/10.1007/s00535-016-1247-4

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1038372931

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/27549242


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