Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study
| Autor: | Davide Pastorelli, Maria Reig, Vincenzo Mazzaferro, Nevena Damjanov, Marie Dupuy, Eric Assenat, Dale Shuster, Lorenza Rimassa, Terri Goldberg, Markus Peck-Radosavljevic, Vittorina Zagonel, Armando Santoro, Brian Schwartz, William P. Harris, Nicola Personeni, Francesca Negri, Philippe Mathurin, W. Sieghart, Thomas Decaens, Jennifer J. Knox, Giovanni Abbadessa, Jordi Bruix, Elena Rota Caremoli, Bruno Daniele, Camillo Porta, Maria Lamar, Luigi Bolondi, Carlos López López, Marc Pracht, Jörg Trojan |
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| Přispěvatelé: | Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Medizinische Universität Wien = Medical University of Vienna, CRLCC Eugène Marquis (CRLCC), Hôpital Claude Huriez [Lille], CHU Lille, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Rok vydání: | 2018 |
| Předmět: |
Male
Time Factors [SDV]Life Sciences [q-bio] Placebo-controlled study Administration Oral Phases of clinical research Gastroenterology chemistry.chemical_compound 0302 clinical medicine 80 and over Medicine Aged 80 and over education.field_of_study Liver Neoplasms Middle Aged Proto-Oncogene Proteins c-met Progression-Free Survival Pyrrolidinones 3. Good health Europe Editorial Commentary Oncology 030220 oncology & carcinogenesis Hepatocellular carcinoma Administration Quinolines Female 030211 gastroenterology & hepatology medicine.drug Oral Adult Sorafenib medicine.medical_specialty Carcinoma Hepatocellular Population Antineoplastic Agents Placebo Drug Administration Schedule Young Adult 03 medical and health sciences Double-Blind Method Internal medicine Humans Progression-free survival Tivantinib education Protein Kinase Inhibitors Aged business.industry Carcinoma Australia Hepatocellular medicine.disease chemistry Americas business New Zealand |
| Zdroj: | Lancet Oncology Lancet Oncology, Elsevier, 2018, 19 (5), pp.682--693. ⟨10.1016/S1470-2045(18)30146-3⟩ Ann Transl Med |
| ISSN: | 1470-2045 |
| DOI: | 10.1016/s1470-2045(18)30146-3 |
| Popis: | International audience; BACKGROUND: Tivantinib (ARQ 197), a selective, oral MET inhibitor, improved overall survival and progression-free survival compared with placebo in a randomised phase 2 study in patients with high MET expression (MET-high) hepatocellular carcinoma previously treated with sorafenib. The aim of this phase 3 study was to confirm the results of the phase 2 trial. METHODS: We did a phase 3, randomised, double-blind, placebo-controlled study in 90 centres in Australia, the Americas, Europe, and New Zealand. Eligible patients were 18 years or older and had unresectable, histologically confirmed, hepatocellular carcinoma, an Eastern Cooperative Oncology Group performance status of 0-1, high MET expression (MET-high; staining intensity score >=2 in >=50% of tumour cells), Child-Pugh A cirrhosis, and radiographically-confirmed disease progression after receiving sorafenib-containing systemic therapy. We randomly assigned patients (2:1) in block sizes of three using a computer-generated randomisation sequence to receive oral tivantinib (120 mg twice daily) or placebo (twice daily); patients were stratified by vascular invasion, extrahepatic spread, and α-fetoprotein concentrations ( |
| Databáze: | OpenAIRE |
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