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厄洛替尼在非小细胞肺癌治疗中的依从性、暴露情况及患者体验。

Adherence, exposure and patients' experiences with the use of erlotinib in non-small cell lung cancer.

作者信息

Timmers Lonneke, Boons Christel C L M, Moes-Ten Hove J, Smit Egbert F, van de Ven Peter M, Aerts Joachim G, Swart Eleonora L, Boven Epie, Hugtenburg Jacqueline G

机构信息

Department of Clinical Pharmacology and Pharmacy, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands,

出版信息

J Cancer Res Clin Oncol. 2015 Aug;141(8):1481-91. doi: 10.1007/s00432-015-1935-0. Epub 2015 Mar 6.

Abstract

PURPOSE

Erlotinib is an orally administered tyrosine kinase inhibitor used for treatment of non-small cell lung cancer. Understanding actual use of medication is essential for optimizing treatment conditions.

METHODS

In this multicentre prospective observational study, patients starting erlotinib treatment were followed for 4 months. Adherence was assessed using a medication event monitoring system (MEMS). Area under the curve (AUC) was determined after 1, 2 and 4 months. Before start and at monthly intervals, patients filled out questionnaires about attitude towards medication and disease, quality of life, symptoms and use in daily practice.

RESULTS

Sixty-two patients (median age 63.5 years, 53 % male) were included of whom 15 were still on treatment after 4 months. MEMS data of 55 patients revealed a mean adherence of 96.8 ± 4.0 %. Over one-third of patients had an adherence rate <95 %. At 1 month, 21 % of patients did not always correctly take erlotinib without food. Associated risk factors were older age, suboptimal adherence, ocular symptoms and stomatitis (all p < 0.05). After 1 month of treatment, fatigue (91 %) and rash (86 %) were the most common symptoms reported. AUCss of erlotinib was higher in patients with rash and patients with moderate-severe anorexia (both p < 0.05).

CONCLUSION

Though adherence to erlotinib treatment is generally high, non-adherence might be an issue in a considerable number of patients. To support optimal erlotinib intake, clinicians need to take adequate measures to ameliorate symptoms and to address adherence and correct intake without food. Especially older patients and those who experience stomatitis may need extra attention.

摘要

目的

厄洛替尼是一种口服酪氨酸激酶抑制剂,用于治疗非小细胞肺癌。了解药物的实际使用情况对于优化治疗条件至关重要。

方法

在这项多中心前瞻性观察研究中,对开始使用厄洛替尼治疗的患者进行了4个月的随访。使用药物事件监测系统(MEMS)评估依从性。在1、2和4个月后测定曲线下面积(AUC)。在开始治疗前及每月,患者填写关于对药物和疾病的态度、生活质量、症状及日常用药情况的问卷。

结果

纳入62例患者(中位年龄63.5岁,53%为男性),其中4个月后仍有15例在接受治疗。55例患者的MEMS数据显示平均依从率为96.8±4.0%。超过三分之一的患者依从率<95%。在1个月时,21%的患者并非总是正确空腹服用厄洛替尼。相关危险因素包括年龄较大、依从性欠佳、眼部症状和口腔炎(均p<0.05)。治疗1个月后,疲劳(91%)和皮疹(86%)是报告最多的常见症状。皮疹患者和中重度厌食患者的厄洛替尼稳态血药浓度曲线下面积(AUCss)较高(均p<0.05)。

结论

尽管厄洛替尼治疗的依从性总体较高,但相当一部分患者可能存在不依从问题。为支持最佳的厄洛替尼摄入,临床医生需要采取适当措施改善症状,并解决依从性和正确空腹服药问题。尤其是老年患者和有口腔炎的患者可能需要格外关注。

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