阿瑞匹坦治疗生物癌症治疗相关严重瘙痒的管理：一项初步研究。

Aprepitant for management of severe pruritus related to biological cancer treatments: a pilot study.

机构信息

Department of Medical Oncology, Campus Bio-Medico University of Rome, Rome, Italy.

出版信息

Lancet Oncol. 2012 Oct;13(10):1020-4. doi: 10.1016/S1470-2045(12)70373-X. Epub 2012 Sep 18.

DOI:10.1016/S1470-2045(12)70373-X

PMID:22995650

Abstract

BACKGROUND

Itch is a common side-effect of treatment with anti-EGFR antibodies and tyrosine-kinase inhibitors. We designed a pilot single-centre study to assess the effects of aprepitant-a neurokinin receptor inhibitor-for management of severe pruritus induced by biological drugs.

METHODS

In this single-group, prospective study, we consecutively enrolled 45 outpatients with metastatic solid tumours treated with biological drugs at the Campus Bio-Medico Hospital of Rome, Rome, Italy, between September, 2010, and November, 2011. We classified patients into two groups: a refactory group, for patients with pruritis refractory to standard treatment, or a naive group, for patients who had not been previously treated for pruritis. Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) was given to patients in the refractory group after at least 1 week of standard systemic treatment. In the naive group, aprepitant was given in the same schedule as the refractory group, after first onset of severe pruritus. Intensity of itch was evaluated by Visual Analogue Scale (VAS) score. The primary endpoint was change in median VAS score. This trial is registered with ClinicalTrials.gov, number NCT01683552.

FINDINGS

Median VAS in the refractory group was 8·00 (95% CI 7·93-8·57) at baseline and 1·00 (0·00-2·00) after 1 week of treatment with aprepitant (p<0·0001). In the naive group, VAS score was 8·00 (7·43-8·37) at baseline and 0·00 (0·06-1·08) after 1 week of treatment (p<0·0001). 41 (91%) patients responded to aprepitant (ie, had a >50% reduction in intensity of pruritis) and pruritus recurred in only six (13%) patients. No adverse events related to aprepitant occurred.

INTERPRETATION

Aprepitant decreases severe pruritus induced by biological treatments; it is an old drug, widely available, and therefore easy to add to the armamentarium of supportive treatment. Although to our knowledge no other studies of the anti-itch activity of aprepitant are planned, the results of our trial warrant confirmation in phase 2 and 3 trials.

FUNDING

None.

摘要

背景

抗 EGFR 抗体和酪氨酸激酶抑制剂治疗会引起瘙痒，这是一种常见的副作用。我们设计了一项单中心研究，以评估阿瑞匹坦（一种神经激肽受体抑制剂）对生物药物引起的严重瘙痒的治疗效果。

方法

在这项单组前瞻性研究中，我们连续招募了意大利罗马 Campus Bio-Medico 医院的 45 名转移性实体瘤患者，他们正在接受生物药物治疗。我们将患者分为两组：难治性组，用于治疗对标准治疗无反应的瘙痒患者；或无治疗组，用于治疗未接受过瘙痒治疗的患者。难治性组患者在接受至少 1 周的标准全身治疗后，给予阿瑞匹坦（第 1 天 125mg；第 3 天 80mg；第 5 天 80mg）。无治疗组患者在出现严重瘙痒后，按照难治性组的方案给予阿瑞匹坦。瘙痒强度采用视觉模拟评分（VAS）进行评估。主要终点是 VAS 评分的中位数变化。该试验在 ClinicalTrials.gov 注册，编号为 NCT01683552。

结果

难治性组患者的 VAS 中位数基线时为 8.00（95%CI 7.93-8.57），接受阿瑞匹坦治疗 1 周后为 1.00（0.00-2.00）（p<0.0001）。无治疗组患者的 VAS 中位数基线时为 8.00（7.43-8.37），接受阿瑞匹坦治疗 1 周后为 0.00（0.06-1.08）（p<0.0001）。41 名（91%）患者对阿瑞匹坦有反应（即瘙痒强度降低≥50%），仅 6 名（13%）患者瘙痒复发。没有与阿瑞匹坦相关的不良反应发生。