Please use this identifier to cite or link to this item: http://doi.org/10.25358/openscience-7702
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dc.contributor.authorGalle, Peter R.-
dc.contributor.authorKudo, Masatoshi-
dc.contributor.authorLlovet, Josep M.-
dc.contributor.authorFinn, Richard S.-
dc.contributor.authorKarwal, Mark-
dc.contributor.authorPezet, Denis-
dc.contributor.authorKim, Tae-You-
dc.contributor.authorYang, Tsai-Sheng-
dc.contributor.authorLonardi, Sara-
dc.contributor.authorTomasek, Jiri-
dc.contributor.authorPhelip, Jean-Marc-
dc.contributor.authorTouchefeu, Yann-
dc.contributor.authorKoh, Su-Jin-
dc.contributor.authorStirnimann, Guido-
dc.contributor.authorLiang, Kun-
dc.contributor.authorOgburn, Kenyon D.-
dc.contributor.authorWang, Chunxiao-
dc.contributor.authorAbada, Paolo-
dc.contributor.authorWidau, Ryan C.-
dc.contributor.authorZhu, Andrew X.-
dc.date.accessioned2022-09-07T10:31:38Z-
dc.date.available2022-09-07T10:31:38Z-
dc.date.issued2021-
dc.identifier.urihttps://openscience.ub.uni-mainz.de/handle/20.500.12030/7717-
dc.description.abstractBackground & 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.en_GB
dc.language.isoengde
dc.rightsCC BY-NC*
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/*
dc.subject.ddc610 Medizinde_DE
dc.subject.ddc610 Medical sciencesen_GB
dc.titleRamucirumab in patients with previously treated advanced hepatocellular carcinoma : impact of liver disease aetiologyen_GB
dc.typeZeitschriftenaufsatzde
dc.identifier.doihttp://doi.org/10.25358/openscience-7702-
jgu.type.dinitypearticleen_GB
jgu.type.versionPublished versionde
jgu.type.resourceTextde
jgu.organisation.departmentFB 04 Medizinde
jgu.organisation.number2700-
jgu.organisation.nameJohannes Gutenberg-Universität Mainz-
jgu.rights.accessrightsopenAccess-
jgu.journal.titleLiver internationalde
jgu.journal.volume41de
jgu.journal.issue11de
jgu.pages.start2759de
jgu.pages.end2767de
jgu.publisher.year2021-
jgu.publisher.nameWiley-Blackwellde
jgu.publisher.placeOxfordde
jgu.publisher.issn1478-3231de
jgu.organisation.placeMainz-
jgu.subject.ddccode610de
jgu.publisher.doi10.1111/liv.14994de
jgu.organisation.rorhttps://ror.org/023b0x485-
Appears in collections:JGU-Publikationen

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