The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting.
Aged
Aged, 80 and over
Antineoplastic Agents
/ adverse effects
Carcinoma, Hepatocellular
/ drug therapy
Fatigue
/ chemically induced
Female
Humans
Hypertension
/ chemically induced
Liver Neoplasms
/ drug therapy
Male
Middle Aged
Phenylurea Compounds
/ adverse effects
Proteinuria
/ chemically induced
Quinolines
/ adverse effects
Response Evaluation Criteria in Solid Tumors
Retrospective Studies
Treatment Outcome
Clinical practice
Efficacy
Hepatocellular carcinoma
Lenvatinib
Journal
Hepatology international
ISSN: 1936-0541
Titre abrégé: Hepatol Int
Pays: United States
ID NLM: 101304009
Informations de publication
Date de publication:
Mar 2019
Mar 2019
Historique:
received:
19
09
2018
accepted:
08
01
2019
pubmed:
24
1
2019
medline:
18
7
2019
entrez:
24
1
2019
Statut:
ppublish
Résumé
Lenvatinib (an inhibitor of vascular endothelial growth factor (GF) receptors 1-3, fibroblast GF receptors 1-4, platelet-derived GF receptor α, rearranged during transfection, and stem cell factor receptor) was non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular carcinoma. This study examined the efficacy and safety of lenvatinib in a real-world setting. This was a retrospective, multicenter, observational study. Inclusion and exclusion criteria were based on the phase 3 trial, and participants were observed for at least 12 weeks. Therapeutic effect was determined using the modified Response Evaluation Criteria In Solid Tumors (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by reductions for lenvatinib-related toxicities were permitted. Grades of adverse events (AEs) complied with the Common Terminology Criteria for Adverse Events version 4.0. All 16 patients included in this study had prior treatment history, and a median 3.9 years had passed since the first treatment. Fatigue, hypertension, and proteinuria were the most frequent AEs, and were higher than Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and symptomatic treatment according to the protocol. In the m-RECIST evaluation at the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 40%. Lenvatinib treatment could be accomplished with safety and good response in a real-world setting.
Sections du résumé
BACKGROUND/PURPOSE
OBJECTIVE
Lenvatinib (an inhibitor of vascular endothelial growth factor (GF) receptors 1-3, fibroblast GF receptors 1-4, platelet-derived GF receptor α, rearranged during transfection, and stem cell factor receptor) was non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular carcinoma. This study examined the efficacy and safety of lenvatinib in a real-world setting.
METHODS
METHODS
This was a retrospective, multicenter, observational study. Inclusion and exclusion criteria were based on the phase 3 trial, and participants were observed for at least 12 weeks. Therapeutic effect was determined using the modified Response Evaluation Criteria In Solid Tumors (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by reductions for lenvatinib-related toxicities were permitted. Grades of adverse events (AEs) complied with the Common Terminology Criteria for Adverse Events version 4.0.
RESULTS
RESULTS
All 16 patients included in this study had prior treatment history, and a median 3.9 years had passed since the first treatment. Fatigue, hypertension, and proteinuria were the most frequent AEs, and were higher than Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and symptomatic treatment according to the protocol. In the m-RECIST evaluation at the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 40%.
CONCLUSION
CONCLUSIONS
Lenvatinib treatment could be accomplished with safety and good response in a real-world setting.
Identifiants
pubmed: 30671808
doi: 10.1007/s12072-019-09929-4
pii: 10.1007/s12072-019-09929-4
doi:
Substances chimiques
Antineoplastic Agents
0
Phenylurea Compounds
0
Quinolines
0
lenvatinib
EE083865G2
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
199-204Références
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