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.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30219 Gastroenterology and hepatology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

Abstract

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 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.

@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 and 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, vol.~41, No~11, p.~2759-2767. ISSN~1478-3223. Available from: https://dx.doi.org/10.1111/liv.14994.

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