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

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 ≥18 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 15 mg, respectively. Calculated MTD of idarubicin was 10 mg. At the 10 mg idarubicin dose, patients presented a longer TTD than at 5 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 41 days (21 to NA) at 5 mg, 23 days (20 to NA) at 10 mg and 25 days (17 to NA) at 15 mg. These results show the importance of studying HRQoL in phase I trials.
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-01384670
Contributeur : Lnc - Université de Bourgogne <>
Soumis le : jeudi 20 octobre 2016 - 12:36:31
Dernière modification le : jeudi 21 février 2019 - 10:16:13

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Amélie Anota, Mathieu Boulin, Sandrine Dabakuyo-Yonli, Patrick Hillon, Jean-Pierre Cercueil, et al.. 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, BMJ Publishing Group, 2016, 6 (6), ⟨10.1136/bmjopen-2015-010696⟩. ⟨hal-01384670⟩

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