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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F21%3A00078665" target="_blank" >RIV/00209805:_____/21:00078665 - isvavai.cz</a>

Výsledek na webu

<a href="https://onlinelibrary.wiley.com/doi/epdf/10.1111/liv.14994" target="_blank" >https://onlinelibrary.wiley.com/doi/epdf/10.1111/liv.14994</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/liv.14994" target="_blank" >10.1111/liv.14994</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

Background &amp; aims: Hepatocellular carcinoma (HCC) is a common complication of chronic liver disease with diverse underlying etiologies. 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 etiology and baseline serum viral load. Methods: Meta-analysis was conducted in patients with aHCC and alpha-fetoprotein (AFP) GREATER-THAN OR EQUAL TO400 ng/mL (N=542) from REACH/REACH-2 trials. Individual patient-level data were pooled with results reported by etiology subgroup (hepatitis B [HBV] or C [HCV] and Other). Pretreatment 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 etiology subgroup was detected (OS interaction p-value= 0.23). 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 etiology subgroups with a tolerable safety profile, supporting its use in patients with aHCC and elevated AFP.

Název v anglickém jazyce

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

Popis výsledku anglicky

Background &amp; aims: Hepatocellular carcinoma (HCC) is a common complication of chronic liver disease with diverse underlying etiologies. 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 etiology and baseline serum viral load. Methods: Meta-analysis was conducted in patients with aHCC and alpha-fetoprotein (AFP) GREATER-THAN OR EQUAL TO400 ng/mL (N=542) from REACH/REACH-2 trials. Individual patient-level data were pooled with results reported by etiology subgroup (hepatitis B [HBV] or C [HCV] and Other). Pretreatment 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 etiology subgroup was detected (OS interaction p-value= 0.23). 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 etiology subgroups with a tolerable safety profile, supporting its use in patients with aHCC and elevated AFP.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Liver international

ISSN

1478-3223

e-ISSN

—

Svazek periodika

41

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

2759-2767

Kód UT WoS článku

000682738200001

EID výsledku v databázi Scopus

2-s2.0-85112645841