title: Second-line ramucirumab therapy for advanced hepatocellular carcinoma (REACH): an East Asian and non-East Asian subgroup analysis.
abstract: OBJECTIVE
  REACH investigated second-line ramucirumab therapy for advanced hepatocellular carcinoma.
  
  
  RESULTS
  Median overall survival was 8.2 months for ramucirumab and 6.9 months for placebo (HR, 0.835; 95% CI, 0.634-1.100; p = 0.2046) for East Asians, and 10.1 months for ramucirumab and 8.0 months for placebo (HR, 0.895; 95% CI, 0.690-1.161; p = 0.4023) for non-East Asians. Median overall survival in patients with baseline alpha-fetoprotein ≥ 400 ng/mL was 7.8 months for ramucirumab and 4.2 months for placebo (HR, 0.749; 95% CI, 0.519-1.082; p = 0.1213) for East Asians (n = 139), and 8.2 months for ramucirumab and 4.5 months for placebo (HR, 0.579; 95% CI, 0.371-0.904; p = 0.0149) for non-East Asians (n = 111). The most common grade ≥ 3 treatment-emergent adverse events in East Asians and non-East Asians included hypertension and malignant neoplasm progression.
  
  
  METHODS
  A post-hoc analysis of East Asians (N = 252) and non-East Asians (N = 313) in the intent-to-treat population was performed.
  
  
  CONCLUSIONS
  In East Asians and non-East Asians, ramucirumab did not significantly prolong overall survival. In patients with baseline alpha-fetoprotein ≥ 400 ng/mL, a potentially larger survival benefit was observed in both subgroups. Safety for East Asians was similar to non-East Asians.
authors: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors: Joon Oh
authors: JO
authors: Park
authors: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors: Baek-Yeol
authors: BY
authors: Ryoo
authors: National Cheng Kung University Hospital, Tainan City, Taiwan.
authors: Chia-Jui
authors: CJ
authors: Yen
authors: Kinki University School of Medicine, Osaka-Sayama City, Osaka, Japan.
authors: Masatoshi
authors: M
authors: Kudo
authors: Eli Lilly and Company, Bridgewater, NJ, USA.
authors: Ling
authors: L
authors: Yang
authors: Eli Lilly and Company, Indianapolis, IN, USA.
authors: Paolo B
authors: PB
authors: Abada
authors: Eli Lilly and Company, Taipei, Taiwan.
authors: Rebecca
authors: R
authors: Cheng
authors: Eli Lilly and Company, Buenos Aires, Argentina.
authors: Mauro
authors: M
authors: Orlando
authors: Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.
authors: Andrew X
authors: AX
authors: Zhu
authors: National Cancer Center Hospital, Tokyo, Japan.
authors: Takuji
authors: T
authors: Okusaka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D019233:Retreatment; D016896:Treatment Outcome; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000096662:Ramucirumab
keywords: Asians; alpha-fetoprotein; clinical trial; liver neoplasms; vascular endothelial growth factor receptor-2