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Alpha-fetoprotein kinetics in patients with hepatocellular carcinoma receiving ramucirumab or placebo: an analysis of the phase 3 REACH study
I. Chau, JO. Park, BY. Ryoo, CJ. Yen, R. Poon, D. Pastorelli, JF. Blanc, M. Kudo, T. Pfiffer, E. Hatano, HC. Chung, K. Kopeckova, JM. Phelip, G. Brandi, S. Ohkawa, CP. Li, T. Okusaka, Y. Hsu, PB. Abada, AX. Zhu,
Language English Country England, Great Britain
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Free Medical Journals
from 1947 to 1 year ago
Freely Accessible Journals
from 1947 to 1 year ago
PubMed Central
from 1947 to 1 year ago
Europe PubMed Central
from 1947 to 1 year ago
ProQuest Central
from 2000-01-01 to 1 year ago
Open Access Digital Library
from 1947-01-01
Open Access Digital Library
from 1999-01-01
Nursing & Allied Health Database (ProQuest)
from 2000-01-01 to 1 year ago
Health & Medicine (ProQuest)
from 2000-01-01 to 1 year ago
Public Health Database (ProQuest)
from 2000-01-01 to 1 year ago
- MeSH
- alpha-Fetoproteins metabolism MeSH
- Adult MeSH
- Carcinoma, Hepatocellular blood diagnostic imaging drug therapy pathology MeSH
- Kaplan-Meier Estimate MeSH
- Middle Aged MeSH
- Humans MeSH
- Antibodies, Monoclonal administration & dosage adverse effects MeSH
- Liver Neoplasms blood diagnostic imaging drug therapy pathology MeSH
- Disease-Free Survival MeSH
- Radiography methods MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Post-hoc analyses of AFP response and progression and their relationship with objective measures of response and survival were performed in patients from REACH. METHODS: Serum AFP was measured at baseline and every 3 cycles (2 weeks/cycle). Associations between AFP and radiographic progression and efficacy end points were analysed. RESULTS: Median percent AFP increase from baseline was smaller in the ramucirumab than in the placebo arm throughout treatment. Time to AFP progression (HR 0.621; P < 0.0001) and to radiographic progression (HR 0.613; P < 0.0001) favoured ramucirumab. Association between AFP and radiographic progression was shown at 6 (OR 6.44, 95% CI 4.03, 10.29; P < 0.0001) and 12 weeks (OR 2.28, 95% CI 1.47, 3.53; P = 0.0002). AFP response was higher with ramucirumab compared with placebo (P < 0.0001). More patients in the ramucirumab arm experienced tumour shrinkage and AFP response compared with placebo. Survival was longer in patients with AFP response (13.6 months) than in patients without (6.2 months), irrespective of treatment (HR 0.457, P < 0.0001). CONCLUSIONS: Treatment with ramucirumab prolonged time to AFP progression, slowed AFP increase and was more likely to induce AFP response. Similar benefits in radiographic progression and response correlated with AFP changes.
Department of Medical Oncology Instituto do Câncer do Estado de São Paulo São Paulo 01246 000 Brazil
Department of Medicine Harvard Medical School Massachusetts General Hospital Boston MA 02114 USA
Department of Medicine Royal Marsden Hospital Sutton Surrey SM2 5PT UK
Department of Oncology Asan Medical Center University of Ulsan College of Medicine Seoul 05505 Korea
Department of Oncology Santa Maria del Prato Hospital Feltre 32032 Italy
Department of Surgery Graduate School of Medicine Kyoto University Kyoto 606 8507 Japan
Departmentof Surgery The University of Hong Kong Pokfulam Hong Kong
Division of Hepatobiliary and Pancreatic Oncology Kanagawa Cancer Center Yokohama 241 0815 Japan
References provided by Crossref.org
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