أعرض في EDS

Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2) : A randomised, double-blind, placebo-controlled, phase 3 trial

التفاصيل البيبلوغرافية
العنوان: Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2) : A randomised, double-blind, placebo-controlled, phase 3 trial
المؤلفون: Marc Pracht, Kenta Motomura, Philippe Merle, Richard S. Finn, Jean-Baptiste Hiriart, Takuji Okusaka, Christophe Borg, Paolo Abada, Masatoshi Kudo, Dong Bok Shin, Guido Gerken, Eric Assenat, Chia Jui Yen, Izumi Ohno, Yoon-Koo Kang, Kun-Ming Rau, Bruno Daniele, Yanzhi Hsu, Andrew X. Zhu, Josep M. Llovet, Peter R. Galle, Manabu Morimoto, Giovanni Brandi, Ho Yeong Lim
المساهمون: Zhu, Andrew X, Kang, Yoon-Koo, Yen, Chia-Jui, Finn, Richard S, Galle, Peter R, Llovet, Josep M, Assenat, Eric, Brandi, Giovanni, Pracht, Marc, Lim, Ho Yeong, Rau, Kun-Ming, Motomura, Kenta, Ohno, Izumi, Merle, Philippe, Daniele, Bruno, Shin, Dong Bok, Gerken, Guido, Borg, Christophe, Hiriart, Jean-Baptiste, Okusaka, Takuji, Morimoto, Manabu, Hsu, Yanzhi, Abada, Paolo B, Kudo, Masatoshi, Harvard Medical School [Boston] (HMS), Asan Medical Center [Seoul], University of Ulsan, National Cheng Kung University (NCKU), David Geffen School of Medicine [Los Angeles], University of California [Los Angeles] (UCLA), University of California-University of California, University Medical Center [Mainz], Icahn School of Medicine at Mount Sinai [New York] (MSSM), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), Centre Eugène Marquis (CRLCC), Sungkyunkwan University [Suwon] (SKKU), Chang Gung Memorial Hospital [Taipei] (CGMH), Fukuoka University, University of Tokyo [Kashiwa Campus], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), G Rummo Hospital, Ospedale del Mare, Gachon University Gil Medical Center [Incheon, Republic of Korea], Universität Duisburg-Essen [Essen], Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Tokyo Medical University, Yokohama University School of Medecine, Eli Lilly and Company [Indianapolis], Kindai University
المصدر: The Lancet Oncology
The Lancet Oncology, 2019, 20 (2), pp.282-296. ⟨10.1016/S1470-2045(18)30937-9⟩
سنة النشر: 2019
مصطلحات موضوعية: Sorafenib, Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Medizin, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, Placebo, Antibodies, Monoclonal, Humanized, Gastroenterology, Ramucirumab, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, Clinical endpoint, Carcinoma, Humans, Aged, Neoplasm Staging, Intention-to-treat analysis, business.industry, Hazard ratio, Liver Neoplasms, MESH: Alpha-Fetoproteins / analysis, Middle Aged, medicine.disease, digestive system diseases, 3. Good health, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, alpha-Fetoproteins, MESH: Carcinoma, Hepatocellular / drug therapy, Liver Neoplasms / blood, Liver Neoplasms / drug therapy, Sorafenib / administration & dosage, business, medicine.drug, MESH: Antibodies, Monoclonal, Humanized /administration & dosage, Antineoplastic Agents / administration & dosage, Carcinoma, Hepatocellular / blood
الوصف: Background: Patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations have poor prognosis. We aimed to establish the efficacy of ramucirumab in patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher. Methods: REACH-2 was a randomised, double-blind, placebo-controlled, phase 3 trial done at 92 hospitals, clinics, and medical centres in 20 countries. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1, α-fetoprotein concentrations of 400 ng/mL or greater, and had previously received first-line sorafenib. Participants were randomly assigned (2:1) via an interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo. All patients received best supportive care. The primary endpoint was overall survival. Secondary endpoints were progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status. We also pooled individual patient data from REACH-2 with data from REACH (NCT01140347) for patients with α-fetoprotein concentrations of 400 ng/mL or greater. Efficacy analyses were by intention to treat, whereas safety analyses were done in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02435433. Findings: Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the placebo group. At a median follow-up of 7·6 months (IQR 4·0–12·5), median overall survival (8·5 months [95% CI 7·0–10·6] vs 7·3 months [5·4–9·1]; hazard ratio [HR] 0·710 [95% CI 0·531–0·949]; p=0·0199) and progression-free survival (2·8 months [2·8–4·1] vs 1·6 months [1·5–2·7]; 0·452 [0·339–0·603]; p
وصف الملف: ELETTRONICO
اللغة: English
تدمد: 1470-2045
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c659e7762c4ea8ec28743092b9b3bf4c
https://www.ncbi.nlm.nih.gov/pubmed/30665869
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....c659e7762c4ea8ec28743092b9b3bf4c
قاعدة البيانات: OpenAIRE
الوصف
تدمد:14702045