2021
Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
GALLE, P. R., M. KUDO, J. M. LLOVET, R. S. FINN, M. KARWAL et. al.Základní údaje
Originální název
Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
Autoři
GALLE, P. R. (garant), M. KUDO, J. M. LLOVET, R. S. FINN, M. KARWAL, D. PEZET, T. Y. KIM, T. S. YANG, S. LONARDI, Jiří TOMÁŠEK (203 Česká republika, domácí), J. M. PHELIP, Y. TOUCHEFEU, S. J. KOH, G. STIRNIMANN, K. LIANG, K. D. OGBURN, C. X. WANG, P. ABADA, R. C. WIDAU a A. X. ZHU
Vydání
Liver International, Hoboken, John Viley & Sons, 2021, 1478-3223
Další údaje
Jazyk
angličtina
Typ výsledku
Článek v odborném periodiku
Obor
30219 Gastroenterology and hepatology
Stát vydavatele
Spojené státy
Utajení
není předmětem státního či obchodního tajemství
Odkazy
Impakt faktor
Impact factor: 8.754
Kód RIV
RIV/00216224:14110/21:00122114
Organizační jednotka
Lékařská fakulta
UT WoS
000682738200001
Klíčová slova anglicky
hepatitis B; hepatitis C; hepatocellular carcinoma; ramucirumab
Změněno: 7. 12. 2021 13:05, Mgr. Tereza Miškechová
Anotace
V originále
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.