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Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: Patient-focused outcome results from the randomised phase III REACH study

Authors
 Ian Chau  ;  Markus Peck-Radosavljevic  ;  Christophe Borg  ;  Peter Malfertheiner  ;  Jean Francois Seitz  ;  Joon Oh Park  ;  Baek-Yeol Ryoo  ;  Chia-Jui Yen  ;  Masatoshi Kudo  ;  Ronnie Poon  ;  Davide Pastorelli  ;  Jean-Frederic Blanc  ;  Hyun Cheol Chung  ;  Ari D. Baron  ;  Takuji Okusaka  ;  L. Bowman  ;  Zhanglin Lin Cui  ;  Allicia C. Girvan  ;  Paolo B. Abada p  ;  Ling Yang  ;  Andrew X. Zhu 
Citation
 European Journal of Cancer, Vol.81 : 17-25, 2017 
Journal Title
 European Journal of Cancer 
ISSN
 0959-8049 
Issue Date
2017
MeSH
Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Carcinoma, Hepatocellular/drug therapy* ; Disease-Free Survival ; Double-Blind Method ; Female ; Humans ; Kaplan-Meier Estimate ; Liver Neoplasms/drug therapy* ; Male ; Middle Aged ; Niacinamide/administration & dosage ; Niacinamide/analogs & derivatives ; Phenylurea Compounds/administration & dosage ; Quality of Life
Keywords
Hepatocellular carcinoma ; Patient-focused outcomes ; Performance status ; Quality of life ; Ramucirumab ; Sorafenib
Abstract
PURPOSE: To report patient-focused outcomes as measured by quality of life (QoL) and performance status (PS) in REACH, a phase III placebo-controlled randomised study, assessing ramucirumab in advanced hepatocellular carcinoma (HCC) patients who received prior sorafenib. METHODS: Eligible patients had advanced HCC, Child-Pugh A, PS 0 or 1 and prior sorafenib. Patients received ramucirumab (8 mg/kg) or placebo (1:1) on day 1 of a 2-week cycle. QoL was assessed by FACT Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL (EQ-5D) at baseline; cycles 4, 10, and 16; and end of treatment. PS was assessed at baseline, each cycle, and end of treatment. Deterioration in FHSI-8 was defined as a ≥3-point decrease from baseline and PS deterioration was defined as a change of ≥2. Both intention-to-treat and pre-specified subgroup of patients with baseline serum alpha-fetoprotein (AFP) ≥400 ng/mL were assessed. RESULTS: There were 565 patients randomised to ramucirumab and placebo. Compliance with FHSI and EQ-5D was high and similar between groups. In the ITT population, deterioration in FHSI-8, EQ-5D, and PS was similar between ramucirumab and placebo. In patients with baseline AFP ≥400 ng/mL, ramucirumab significantly reduced deterioration in FHSI-8 at the end of treatment compared with placebo (P = 0.0381), and there was a trend towards a delay in the deterioration of symptoms in FHSI-8 (HR 0.690; P = 0.054) and PS (HR 0.642; P = 0.057) in favour of ramucirumab. CONCLUSIONS: We report one of the most comprehensive data sets of QoL and symptom burden in patients undergoing systemic therapy for advanced HCC. Ramucirumab was associated with no worsening of QoL. In patients with baseline AFP ≥400 ng/mL, the significant survival benefit observed in patients treated with ramucirumab was coupled with a trend in patient-focused outcome benefits.
Full Text
https://www.sciencedirect.com/science/article/pii/S0959804917309334
DOI
10.1016/j.ejca.2017.05.001
Appears in Collections:
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
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/160322
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