Second-line ramucirumab therapy for advanced hepatocellular carcinoma (REACH): an East Asian and non-East Asian subgroup analysis
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Joon Oh Park1, Baek-Yeol Ryoo2, Chia-Jui Yen3, Masatoshi Kudo4, Ling Yang5, Paolo B. Abada6, Rebecca Cheng7, Mauro Orlando8, Andrew X. Zhu9, Takuji Okusaka10
1Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
2Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
3National Cheng Kung University Hospital, Tainan City, Taiwan
4Kinki University School of Medicine, Osaka-Sayama City, Osaka, Japan
5Eli Lilly and Company, Bridgewater, NJ, USA
6Eli Lilly and Company, Indianapolis, IN, USA
7Eli Lilly and Company, Taipei, Taiwan
8Eli Lilly and Company, Buenos Aires, Argentina
9Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA
10National Cancer Center Hospital, Tokyo, Japan
Joon Oh Park, email: [email protected]
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
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.
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