Abstract

Administration of Nalfurafine Hydrochloride in Patients with Hepatocellular Carcinoma and Refractory Pruritus Improved Patient-Reported Outcome

Author(s): Toru Ishikawa, Hiroshi Hirosawa

Background: Patients with hepatocellular carcinoma (HCC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in HCC patients with refractory pruritus. Herein, we conducted a study to investigate the efficacy of nalfurafine hydrochloride in terms of PRO.
Methods: We identified 21 chronic liver disease patients with pruritus after screening for pruritus. The participants received 2.5 μg nalfurafine hydrochloride once daily. Generic HRQOL using short form 36 (SF-36) and the visual analog scale (VAS) were also measured at baseline and at end of treatment.
Results: VAS significantly declined during the study period, from 43.7 ± 34.1 to 14.3 ± 23.8 (p = 0.002) at bedtime between baseline and end of treatment, respectively, indicating a significant effect of nalfurafine hydrochloride. In HCC group, the mean VAS at baseline and at end of treatment was 46.8 ± 35.3 and 13.0 ± 19.4, respectively, representing a more pronounced reduction (p = 0.009) at bednight. Furthermore, the mean VAS at baseline and at end of treatment was 31.1 ± 31.7 and 6.6 ± 8.2, respectively, representing a more pronounced reduction (p = 0.042) at upon awaking. Vitality (VT) and mental health (MH) improved in overall chronic liver disease patients undergoing this therapy. VT domains of SF-36 was significantly altered by this treatment in HCC group (p=0.045).
Conclusions: This study demonstrated that nalfurafine hydrochloride improved pruritus in chronic liver disease patients, and more effective on the PRO in chronic liver disease patients with HCC. PDF