Journal article
Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
Liver international, Vol.41(11), pp.2759-2767
11/2021
DOI: 10.1111/liv.14994
PMID: 34173317
Abstract
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.
Details
- Title: Subtitle
- Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
- Creators
- Peter R. Galle - Department of Internal Medicine, Mainz University Medical Center, Mainz, Germany.Masatoshi Kudo - Kindai UniversityJosep M. Llovet - Universitat de BarcelonaRichard S. Finn - University of California, Los AngelesMark Karwal - University of IowaDenis Pezet - University of Clermont-FerrandTae‐You Kim - Seoul National University HospitalTsai‐Sheng Yang - Chang Gung Memorial HospitalSara Lonardi - Istituto Oncologico VenetoJiri Tomasek - Masaryk Memorial Cancer InstituteJean‐Marc Phelip - University Hospital Saint‐Etienne NorthYann Touchefeu - CHU Hôtel-Dieu, Nantes, France.Su‐Jin Koh - University of UlsanGuido Stirnimann - University Hospital of BernKun Liang - Eli Lilly (United States)Kenyon D. Ogburn - Eli Lilly (United States)Chunxiao Wang - Eli Lilly (United States)Paolo Abada - Eli Lilly (United States)Ryan C. Widau - Eli Lilly (United States)Andrew X. Zhu - Massachusetts General Hospital
- Resource Type
- Journal article
- Publication Details
- Liver international, Vol.41(11), pp.2759-2767
- DOI
- 10.1111/liv.14994
- PMID
- 34173317
- NLM abbreviation
- Liver Int
- ISSN
- 1478-3223
- eISSN
- 1478-3231
- Number of pages
- 9
- Grant note
- Eli Lilly and Company
- Language
- English
- Date published
- 11/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359590902771
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