A phase I pharmacokinetic study of lenvatinib in Chinese patients with unresectable hepatocellular carcinoma.
Future Oncol
; 18(22): 2413-2424, 2022 Jul.
Article
em En
| MEDLINE
| ID: mdl-35674480
ABSTRACT
Aim:
This phase I study assessed the pharmacokinetic profile, safety and antitumor activity of lenvatinib in Chinese patients with unresectable hepatocellular carcinoma. Materials &methods:
Bodyweight-based lenvatinib dosing was administered (patients <60 kg 8 mg/day, n = 13; patients ≥60 kg 12 mg/day, n = 12). Pharmacokinetic sampling was performed during the first cycle. Efficacy and safety were assessed.Results:
There was considerable overlap between individual exposure values at steady-state in the 8 and 12 mg groups. The most common adverse events were increased blood bilirubin and decreased platelet count (48.0%). Two patients had partial responses, and 16 patients attained stable disease.Conclusion:
No significant pharmacokinetic differences between dose groups were detected. Lenvatinib was tolerable, showing promising antitumor activities in Chinese patients with unresectable hepatocellular carcinoma.
Hepatocellular carcinoma (HCC; liver cancer) is common in Chinese patients. Lenvatinib is a drug approved to treat HCC, and patients with higher bodyweights are given a higher dose than patients with lower bodyweights. This trial in Chinese patients with HCC looked at lenvatinib pharmacokinetics (what the body does to a drug) after one dose and multiple doses, and at lenvatinib's antitumor activity and side effects. Meaningful differences in pharmacokinetics between the higher and lower doses after a single dose or multiple doses of daily lenvatinib were not observed. Lenvatinib partially shrank the tumors of 2 out of 21 patients whose tumors were assessed. The side effects seen matched those from other studies of lenvatinib in HCC and other cancers. ClinicalTrial Registration NCT02953743 (ClinicalTrials.gov).
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Quinolinas
/
Carcinoma Hepatocelular
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Neoplasias Hepáticas
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Antineoplásicos
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
Future Oncol
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
China