A phase II study of sunitinib in advanced hepatocellular carcinoma.
Dig Liver Dis
; 45(8): 692-8, 2013 Aug.
Article
em En
| MEDLINE
| ID: mdl-23410734
ABSTRACT
BACKGROUND:
In 2007, sorafenib was the first drug able to improve overall survival in patients with advanced hepatocellular carcinoma.AIM:
In 2005 we designed a phase II study to assess safety and efficacy of sunitinib.METHODS:
This is a single arm, open-label, single-centre phase II trial. Eligibility criteria were advanced hepatocellular carcinoma; no prior chemotherapy, performance status 0-1; and Child≤B8. The treatment schedule was 50mg each day orally, 4 weeks on, 2 weeks off.RESULTS:
Between 10/2007 and 10/2010, 34 patients were enrolled. A significant worsening of liver functional reserve after sunitinib was observed. Grade 3/4 adverse effects occurred in 80% of patients and included fatigue (47%), nausea (15%), liver failure (15%), encephalopathy (12%) and upper gastrointestinal bleeding (12%). Six patients (18%) died within 60 days of enrolment. A partial response was observed in 4 patients (12%). Median time to tumour progression was 2.8 months and median overall survival was 5.8 months.CONCLUSION:
A dose of 50mg/d induces a high rate of severe adverse events. Toxicity remains a key concern also at the dose of 37.5mg/d. However, sunitinib is able to induce a prolonged response in some patients. Positron Emission Tomography/Computed Tomography scans may select good responders.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pirróis
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Carcinoma Hepatocelular
/
Indóis
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Neoplasias Hepáticas
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Antineoplásicos
Tipo de estudo:
Etiology_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
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Female
/
Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article