GALLE, P. R., M. KUDO, J. M. LLOVET, R. S. FINN, M. KARWAL, D. PEZET, T. Y. KIM, T. S. YANG, S. LONARDI, Jiří TOMÁŠEK, J. M. PHELIP, Y. TOUCHEFEU, S. J. KOH, G. STIRNIMANN, K. LIANG, K. D. OGBURN, C. X. WANG, P. ABADA, R. C. WIDAU and A. X. ZHU. Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology. Liver International. Hoboken: John Viley & Sons, 2021, vol. 41, No 11, p. 2759-2767. ISSN 1478-3223. Available from: https://dx.doi.org/10.1111/liv.14994.
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Basic information
Original name Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
Authors GALLE, P. R. (guarantor), M. KUDO, J. M. LLOVET, R. S. FINN, M. KARWAL, D. PEZET, T. Y. KIM, T. S. YANG, S. LONARDI, Jiří TOMÁŠEK (203 Czech Republic, belonging to the institution), J. M. PHELIP, Y. TOUCHEFEU, S. J. KOH, G. STIRNIMANN, K. LIANG, K. D. OGBURN, C. X. WANG, P. ABADA, R. C. WIDAU and A. X. ZHU.
Edition Liver International, Hoboken, John Viley & Sons, 2021, 1478-3223.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30219 Gastroenterology and hepatology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 8.754
RIV identification code RIV/00216224:14110/21:00122114
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1111/liv.14994
UT WoS 000682738200001
Keywords in English hepatitis B; hepatitis C; hepatocellular carcinoma; ramucirumab
Tags 14110811, rivok
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 7/12/2021 13:05.
Abstract
Background & Aims Hepatocellular carcinoma (HCC) is a common complication of chronic liver disease with diverse underlying aetiologies. REACH/REACH-2 were global phase III studies investigating ramucirumab in advanced HCC (aHCC) following sorafenib treatment. We performed an exploratory analysis of outcomes by liver disease aetiology and baseline serum viral load. Methods Meta-analysis was conducted in patients with aHCC and alpha-fetoprotein (AFP) >= 400 ng/mL (N = 542) from REACH/REACH-2 trials. Individual patient-level data were pooled with results reported by aetiology subgroup (hepatitis B [HBV] or C [HCV] and Other). Pre-treatment serum HBV DNA and HCV RNA were quantified using Roche COBAS AmpliPrep/COBAS TaqMan. Overall survival (OS) and progression-free survival (PFS) were evaluated using the Kaplan-Meier method and Cox proportional hazard model (stratified by study). Results Baseline characteristics were generally balanced between arms in each subgroup (HBV: N = 225, HCV: N = 127, Other: N = 190). No significant difference in treatment effect by aetiology subgroup was detected (OS interaction P-value = .23). Median OS (ramucirumab vs placebo) in months was 7.7 versus 4.5 (HR 0.74, 95% CI 0.55-0.99) for HBV, 8.2 versus 5.5 (HR 0.82, 95% CI 0.55-1.23) for HCV and 8.5 versus 5.4 (HR 0.56, 95% CI 0.40-0.79) for Other. Ramucirumab showed similar overall safety profiles across subgroups. Worst outcomes were noted in patients with a detectable HBV load. Use of HBV antiviral therapy, irrespective of viral load, was beneficial for survival, liver function and liver-specific adverse events. Conclusions Ramucirumab improved survival across aetiology subgroups with a tolerable safety profile, supporting its use in patients with aHCC and elevated AFP.
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