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Second-line ramucirumab therapy for advanced hepatocellular carcinoma (REACH): an East Asian and non-East Asian subgroup analysis

2016; Impact Journals LLC; Volume: 7; Issue: 46 Linguagem: Inglês

10.18632/oncotarget.12780

1949-2553

Joon Oh Park, Baek‐Yeol Ryoo, Chia-Jui Yen, Masatoshi Kudo, Ling Yang, Paolo Abada, Rebecca Cheng, Mauro Orlando, Andrew X. Zhu, Takuji Okusaka,

Pancreatic and Hepatic Oncology Research

// Joon Oh Park 1 , Baek-Yeol Ryoo 2 , Chia-Jui Yen 3 , Masatoshi Kudo 4 , Ling Yang 5 , Paolo B. Abada 6 , Rebecca Cheng 7 , Mauro Orlando 8 , Andrew X. Zhu 9 , Takuji Okusaka 10 1 Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea 2 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea 3 National Cheng Kung University Hospital, Tainan City, Taiwan 4 Kinki University School of Medicine, Osaka-Sayama City, Osaka, Japan 5 Eli Lilly and Company, Bridgewater, NJ, USA 6 Eli Lilly and Company, Indianapolis, IN, USA 7 Eli Lilly and Company, Taipei, Taiwan 8 Eli Lilly and Company, Buenos Aires, Argentina 9 Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA 10 National Cancer Center Hospital, Tokyo, Japan Correspondence to: Joon Oh Park, email: oncopark@skku.edu Keywords: Asians, alpha-fetoprotein, clinical trial, liver neoplasms, vascular endothelial growth factor receptor-2 Received: May 23, 2016 Accepted: October 10, 2016 Published: October 20, 2016 ABSTRACT Purpose: 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. Materials and 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.