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Subgroup analysis of East Asian patients in REGARD: A phase III trial of ramucirumab and best supportive care for advanced gastric cancer

 Hyun Cheol Chung  ;  Victor C Kok  ;  Rebecca Cheng  ;  Yanzhi Hsu  ;  Mauro Orlando  ;  Charles Fuchs  ;  Jae Yong Cho 
 Asia-Pacific Journal of Clinical Oncology, Vol.14(3) : 204-209, 2018 
Journal Title
 Asia-Pacific Journal of Clinical Oncology 
Issue Date
Asia ; gastric cancer ; gastrointestinal neoplasms ; ramucirumab ; vascular endothelial growth factor receptor-2
AIM: We describe a subgroup analysis assessing the efficacy and safety of ramucirumab monotherapy in East Asian (EA) patients from the REGARD trial. METHODS: Patients with advanced gastric or gastroesophageal junction adenocarcinoma with progressive disease were randomized 2:1 to receive ramucirumab (8 mg/kg) plus best supportive care (BSC) or placebo plus BSC every 2 weeks. Post hoc subset analyses were performed on the EA and non-EA intention-to-treat populations. RESULTS: Of 355 intention-to-treat patients, 26 patients from EA were randomized to ramucirumab (n = 18) or placebo (n = 8). Median overall survival was 6.5 months in the ramucirumab arm and 4.8 months in the placebo arm (hazard ratio [HR] 0.69; 95% confidence interval [CI], 0.27-1.82) for EA patients, and 5.2 months in the ramucirumab arm and 3.8 months in the placebo arm (HR 0.78; 95% CI, 0.60-1.02) for non-EA patients. The rate of disease control was numerically higher in ramucirumab patients versus placebo; 61% versus 38% respectively for EA patients, and 48% versus 22% for non-EA patients. The incidence of grade >/=3 treatment emergent adverse events was higher in the ramucirumab arm compared to placebo (39% vs 13%). CONCLUSION: Despite limitations, this subgroup analysis suggests that ramucirumab monotherapy improves efficacy outcomes with a tolerable safety profile in EA patients with previously treated advanced gastric cancer.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
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