An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma.
BMJ Open
; 6(6): e010696, 2016 06 24.
Article
em En
| MEDLINE
| ID: mdl-27342239
ABSTRACT
OBJECTIVES:
The objective of this study was to explore the association between health-related quality of life (HRQoL) and the recommended phase 2 dose in a phase I clinical trial according to the Time to HRQoL deterioration approach (TTD).SETTING:
This is a phase I dose-escalation trial of transarterial chemoembolisation (TACE) with idarubicin-loaded beads performed in cirrhotic patients with hepatocellular carcinoma. Patients had to complete the EORTC QLQ-C30 HRQoL questionnaire at baseline and at days 15, 30 and 60 after TACE.PARTICIPANTS:
Patients aged ≥18â years with HCC unsuitable for curative treatments were evaluated for the study (N=21). PRIMARY AND SECONDARY OUTCOME MEASUREMENTS The primary objective was to determine the maximum tolerated dose (MTD) of idarubicin loaded after a single TACE session. MTD was defined as the dose level closest to that causing dose-limiting toxicity in 20% of patients. HRQoL was the secondary end point.RESULTS:
Between March 2010 and March 2011, 9, 6 and 6 patients were included at idarubicin dose levels of 5, 10 and 15â mg, respectively. Calculated MTD of idarubicin was 10â mg. At the 10â mg idarubicin dose, patients presented a longer TTD than at 5â mg, for global health status (HR=0.91 (95% CI 0.18 to 4.72)), physical functioning (HR=0.38 (0.04 to 3.22)), fatigue (HR=0.67 (0.18 to 2.56)) and pain (HR=0.47 (0.05 to 4.24)).CONCLUSIONS:
These HRQoL results were consistent with the estimated MTD, with a median TTD for global health status of 41â days (21 to NA) at 5â mg, 23â days (20 to NA) at 10â mg and 25â days (17 to NA) at 15â mg. These results show the importance of studying HRQoL in phase I trials. TRIAL REGISTRATION NUMBER NCT01040559; Post-results.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Temas:
Cuidados_paliativos
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Geral
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Tipos_de_cancer
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Outros_tipos
Base de dados:
MEDLINE
Assunto principal:
Qualidade de Vida
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Idarubicina
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Quimioembolização Terapêutica
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Carcinoma Hepatocelular
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Neoplasias Hepáticas
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Antibióticos Antineoplásicos
Tipo de estudo:
Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
França