J 2020

Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2

KUDO, M., P. R. GALLE, J. M. LLOVET, R. S. FINN, A. VOGEL et. al.

Základní údaje

Originální název

Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2

Autoři

KUDO, M. (392 Japonsko, garant), P. R. GALLE (276 Německo), J. M. LLOVET (724 Španělsko), R. S. FINN (840 Spojené státy), A. VOGEL (276 Německo), K. MOTOMURA (392 Japonsko), E. ASSENAT (250 Francie), P. MERLE (380 Itálie), G. BRANDI (380 Itálie), B. DANIELE (380 Itálie), T. OKUSAKA (392 Japonsko), Jiří TOMÁŠEK (203 Česká republika, domácí), C. BORG (250 Francie), V. DADDUZIO (380 Itálie), M. MORIMOTO (392 Japonsko), M. PRACHT (250 Francie), M. H. JEN (826 Velká Británie a Severní Irsko), N. D. UBREVA (392 Japonsko), R. C. WIDAU (840 Spojené státy), K. SHINOZAKI (392 Japonsko), R. YOSHIKAWA (392 Japonsko) a A. X. ZHU (840 Spojené státy)

Vydání

Liver International, Hoboken, John Viley & Sons, 2020, 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

Impakt faktor

Impact factor: 5.828

Kód RIV

RIV/00216224:14110/20:00116137

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

000530611100001

Klíčová slova anglicky

alpha-fetoprotein (AFP); elderly; hepatocellular carcinoma; ramucirumab; sorafenib intolerance; VEGFR2

Štítky

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 5. 8. 2020 14:30, Mgr. Tereza Miškechová

Anotace

V originále

Background & Aims Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH-2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha-fetoprotein (AFP) >= 400 ng/mL showed an overall ssurvival (OS) benefit for ramucirumab. These post-hoc analyses examined efficacy and safety of ramucirumab in patients with HCC and baseline AFP >= 400 ng/mL by three prespecified age subgroups (<65, >= 65 to <75 and >= 75 years). Methods Individual patient data were pooled from REACH (baseline AFP >= 400 ng/mL) and REACH-2. Kaplan-Meier and Cox proportional hazards regression methods (stratified by study) assessed OS, progression-free survival (PFS), time to progression (TTP) and patient-reported outcomes (Functional Hepatobiliary System Index-8 [FHSI-8] score). Results A total of 542 patients (<65 years: n = 302; >= 65 to <75 years: n = 160; >= 75 years: n = 80) showed similar baseline characteristics between ramucirumab and placebo. Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup. Ramucirumab prolonged OS in patients <65 years (hazard ratio [HR], 0.753; 95% CI 0.581-0.975), >= 65 to <75 years (0.602; 0.419-0.866) and >= 75 years (0.709; 0.420-1.199), PFS and TTP irrespective of age. Ramucirumab showed similar overall safety profiles across subgroups, with a consistent median relative dose intensity >= 97.8%. A trend towards a delay in symptom deterioration in FHSI-8 with ramucirumab was observed in all subgroups. Conclusions In this post-hoc analysis, ramucirumab showed a survival benefit across age subgroups with a tolerable safety profile, supporting its use in advanced HCC with elevated AFP, irrespective of age, including >= 75 years.