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A review of erlotinib--an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor.

机译：厄洛替尼-口服选择性表皮生长因子受体酪氨酸激酶抑制剂的综述。

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摘要

IMPORTANCE OF THE FIELD: The epidermal growth factor receptor (EGFR) is a cell surface receptor for EGF and transforming growth factor-alpha which is overexpressed by a number of human tumors. Erlotinib, developed by OSI Pharmaceuticals, is an oral selective EGFR tyrosine kinase inhibitor, the only drug of its class approved for the treatment of locally advanced non-small cell lung cancer (NSCLC) after failure of at least one previous chemotherapy regimen and for first-line treatment of advanced pancreatic cancer with gemcitabine. AREAS COVERED IN THIS REVIEW: Findings from major Phase III studies that led to the approval of erlotinib are summarized in this review. Key aspects of erlotinib clinical pharmacology, dosing in special populations (e.g., smokers), and toxicity are also reviewed. The article also outlines the results of all correlative studies that have been done in clinical trials of patients receiving erlotinib to identify biomarkers that predict response, such as rash, EGFR status of the tumor by immunohistochemistry and activating EGFR mutations. WHAT WILL THE READER GAIN: The reader will have an outline of the landmark trials leading to the approval of this drug and know which ongoing Phase III trials are expected to enhance the knowledge of this drug's activity. The reader will also understand the pharmacologic bases for the recent change in dosing guidelines of erlotinib, and the current knowledge of clinical and laboratory correlates that can serve as surrogates of response. TAKE HOME MESSAGE: This is a well-tolerated oral biologic agent with two approved clinical indications. More studies to individualize therapy and optimize dosing are needed.
机译：领域的重要性：表皮生长因子受体（EGFR）是EGF和转化生长因子-α的细胞表面受体，在许多人类肿瘤中都过表达。由OSI Pharmaceuticals开发的厄洛替尼是一种口服选择性EGFR酪氨酸激酶抑制剂，是该类药物中的唯一一种，该药物在至少一种先前的化疗方案失败后首次被批准用于治疗局部晚期非小细胞肺癌（NSCLC）。吉西他滨在线治疗晚期胰腺癌。该评价涵盖的领域：本综述总结了导致埃洛替尼获批的主要III期研究发现。还综述了厄洛替尼临床药理学的关键方面，特殊人群的剂量（例如吸烟者）以及毒性。本文还概述了接受厄洛替尼治疗的患者的临床试验中所有相关研究的结果，以鉴定可预测反应的生物标记物，如皮疹，通过免疫组织化学和激活EGFR突变的肿瘤EGFR状态。读者将获得什么：读者将概述导致该药物获批的里程碑式试验的概况，并知道哪些正在进行的III期试验有望增强对该药物活性的了解。读者还将了解厄洛替尼剂量指南近期变化的药理基础，以及有关临床和实验室相关知识的最新知识，可以作为反应的替代指标。温馨提示：这是一种耐受良好的口服生物制剂，具有两种已获批准的临床适应症。需要更多的研究来个体化治疗和优化剂量。

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