Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial
| Autor: | Josep M. Llovet, Gerold Meinhardt, Valeriy Breder, Marie Aude Leberre, Tianqiang Song, Jean-Pierre Bronowicki, Gianluca Masi, Ann-Lii Cheng, György Bodoky, Jordi Bruix, Shukui Qin, René Gerolami, Isabelle Ollivier-Hourmand, Olivier Rosmorduc, Annette Baumhauer, Masatoshi Kudo, Osamu Yokosuka, Paul Ross, Marc Pracht, Philippe Merle, Richard S. Finn, Guohong Han, Alessandro Granito, Yi Hsiang Huang |
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| Přispěvatelé: | DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE |
| Rok vydání: | 2017 |
| Předmět: |
Male
Niacinamide Sorafenib medicine.medical_specialty Carcinoma Hepatocellular Pyridines Population Antineoplastic Agents Kaplan-Meier Estimate Placebo Aged Double-Blind Method Female Humans Liver Neoplasms Middle Aged Phenylurea Compounds Treatment Outcome Medicine (all) law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine Regorafenib medicine Clinical endpoint education education.field_of_study Intention-to-treat analysis business.industry Carcinoma Hepatocellular General Medicine Surgery chemistry 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Liver function business medicine.drug |
| Zdroj: | Bruix, J, Qin, S, Merle, P, Granito, A, Huang, Y-H, Bodoky, G, Pracht, M, Yokosuka, O, Rosmorduc, O, Breder, V, Gerolami, R, Masi, G, Ross, P J, Song, T, Bronowicki, J-P, Ollivier-Hourmand, I, Kudo, M, Cheng, A-L, Llovet, J M, Finn, R S, LeBerre, M-A, Baumhauer, A, Meinhardt, G & Han, G 2016, ' Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial ', Lancet . https://doi.org/10.1016/S0140-6736(16)32453-9 |
| ISSN: | 0140-6736 0177-4344 |
| DOI: | 10.1016/s0140-6736(16)32453-9 |
| Popis: | none 24 si Published Online December 5, 2016 Background: There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment. Methods: In this randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults with HCC who tolerated sorafenib (≥400 mg/day for ≥20 of last 28 days of treatment), progressed on sorafenib, and had Child-Pugh A liver function were enrolled. Participants were randomly assigned (2:1) by a computer-generated randomisation list and interactive voice response system and stratified by geographical region, Eastern Cooperative Oncology Group performance status, macrovascular invasion, extrahepatic disease, and α-fetoprotein level to best supportive care plus oral regorafenib 160 mg or placebo once daily during weeks 1-3 of each 4-week cycle. Investigators, patients, and the funder were masked to treatment assignment. The primary endpoint was overall survival (defined as time from randomisation to death due to any cause) and analysed by intention to treat. This trial is registered with . ClinicalTrials.gov, number . NCT01774344. Findings: Between May 14, 2013, and Dec 31, 2015, 843 patients were screened, of whom 573 were enrolled and randomised (379 to regorafenib and 194 to placebo; population for efficacy analyses), and 567 initiated treatment (374 received regorafenib and 193 received placebo; population for safety analyses). Regorafenib improved overall survival with a hazard ratio of 0·63 (95% CI 0·50-0·79; one-sided p |
| Databáze: | OpenAIRE |
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