Sorafenib in metastatic uveal melanoma: efficacy, toxicity and health-related quality of life in a multicentre phase II study.
Br J Cancer
; 115(1): 20-4, 2016 Jun 28.
Article
em En
| MEDLINE
| ID: mdl-27253171
ABSTRACT
BACKGROUND:
The aim of the study was to analyse efficacy, safety, and health-related quality of life (HRQoL) for sorafenib treatment in patients with metastatic uveal melanoma.METHODS:
A multicentre, single-arm phase II trial was conducted. The primary objective was to determine the non-progression rate (RECIST) at 24 weeks for patients receiving sorafenib at a dose of 800 mg per day. Secondary endpoints included progression-free survival (PFS), overall survival (OS), toxicity, and HRQoL.RESULTS:
Thirty-two patients were included. Ten patients showed non-progression at 24 weeks (31.2%) without objective tumour responses. The estimated 24-week PFS was 31.2% (95% CI 14.8%-47.6%) and the estimated 24-week OS was 62.5% (95% CI 45.4%-79.6%). Ten patients (34.3%) had at least one grade 3 or 4 adverse reaction and 12 patients (41.4%) required dose modifications due to toxicity. At 24 weeks, no patient had an improvement in global HRQoL and 87.5% experienced a permanent increase in physical fatigue.CONCLUSIONS:
Sorafenib demonstrated non-progression at 24 weeks in 31.2% of patients. However, 41.4% of patients required dose modifications due to toxicity and no improvement in HRQoL was demonstrated.
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Base de dados:
MEDLINE
Assunto principal:
Compostos de Fenilureia
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Neoplasias Uveais
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Niacinamida
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Melanoma
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Antineoplásicos
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article