Oncotarget

Research Papers:

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

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

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Oncotarget. 2016; 7:75482-75491. https://doi.org/10.18632/oncotarget.12780

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Abstract

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

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.


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