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Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
M. Kudo, PR. Galle, JM. Llovet, RS. Finn, A. Vogel, K. Motomura, E. Assenat, P. Merle, G. Brandi, B. Daniele, T. Okusaka, J. Tomášek, C. Borg, V. Dadduzio, M. Morimoto, M. Pracht, MH. Jen, N. Drove Ubreva, RC. Widau, K. Shinozaki, R. Yoshikawa, AX. Zhu
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
32279446
DOI
10.1111/liv.14462
Knihovny.cz E-zdroje
- MeSH
- alfa-fetoproteiny MeSH
- hepatocelulární karcinom * farmakoterapie MeSH
- humanizované monoklonální protilátky MeSH
- lidé MeSH
- nádory jater * farmakoterapie MeSH
- senioři MeSH
- sorafenib MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine Osaka Japan
Department of Hepatobiliary and Pancreatic Oncology Kanagawa Cancer Center Yokohama Japan
Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital Tokyo Japan
Department of Hepatology Aso Iizuka Hospital Fukuoka Japan
Department of Internal Medicine Mainz University Medical Center Mainz Germany
Department of Medical Oncology Centre Eugène Marquis Rennes France
Department of Medical Oncology CHU de Montpellier Montpellier France
Department of Medical Oncology University Hospital of Besançon Besançon France
Department of Oncology Azienda Ospedaliera Gaetano Rummo Benevento Italy
Global Statistical Sciences Eli Lilly and Company Surrey UK
Hepatology and Gastroenterology Unit Croix Rousse Hospital Northern Lyon Hospital Group Lyon France
Medicines Development Unit Japan Eli Lilly Japan K K Kobe Japan
Citace poskytuje Crossref.org
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