Ramucirumab in patients with previously treated advanced
hepatocellular carcinoma: Impact of liver disease aetiology

J 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

URL

Impakt faktor

Impact factor: 8.754

Kód RIV

RIV/00216224:14110/21:00122114

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1111/liv.14994

UT WoS

000682738200001

Klíčová slova anglicky

hepatitis B; hepatitis C; hepatocellular carcinoma; ramucirumab

Štítky

14110811, rivok

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.

Citovat

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 a A. X. ZHU. Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology. Liver International. Hoboken: John Viley & Sons, 2021, roč. 41, č. 11, s. 2759-2767. ISSN 1478-3223. Dostupné z: https://dx.doi.org/10.1111/liv.14994.

@article{1786777,
   author = {Galle, P. R. and Kudo, M. and Llovet, J. M. and Finn, R. S. and Karwal, M. and Pezet, D. and Kim, T. Y. and Yang, T. S. and Lonardi, S. and Tomášek, Jiří and Phelip, J. M. and Touchefeu, Y. and Koh, S. J. and Stirnimann, G. and Liang, K. and Ogburn, K. D. and Wang, C. X. and Abada, P. and Widau, R. C. and Zhu, A. X.},
   article_location = {Hoboken},
   article_number = {11},
   doi = {http://dx.doi.org/10.1111/liv.14994},
   keywords = {hepatitis B; hepatitis C; hepatocellular carcinoma; ramucirumab},
   language = {eng},
   issn = {1478-3223},
   journal = {Liver International},
   title = {Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology},
   url = {https://onlinelibrary.wiley.com/doi/10.1111/liv.14994},
   volume = {41},
   year = {2021}
}

TY  - JOUR
ID  - 1786777
AU  - Galle, P. R. - Kudo, M. - Llovet, J. M. - Finn, R. S. - Karwal, M. - Pezet, D. - Kim, T. Y. - Yang, T. S. - Lonardi, S. - Tomášek, Jiří - Phelip, J. M. - Touchefeu, Y. - Koh, S. J. - Stirnimann, G. - Liang, K. - Ogburn, K. D. - Wang, C. X. - Abada, P. - Widau, R. C. - Zhu, A. X.
PY  - 2021
TI  - Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
JF  - Liver International
VL  - 41
IS  - 11
SP  - 2759-2767
EP  - 2759-2767
PB  - John Viley & Sons
SN  - 14783223
KW  - hepatitis B
KW  - hepatitis C
KW  - hepatocellular carcinoma
KW  - ramucirumab
UR  - https://onlinelibrary.wiley.com/doi/10.1111/liv.14994
N2  - 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.
ER  -

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 a A. X. ZHU. Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology. \textit{Liver International}. Hoboken: John Viley \&{} Sons, 2021, roč.~41, č.~11, s.~2759-2767. ISSN~1478-3223. Dostupné z: https://dx.doi.org/10.1111/liv.14994.

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