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首页> 外文期刊>Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners >Flipped script for gefitinib: A reapproved tyrosine kinase inhibitor for first-line treatment of epidermal growth factor receptor mutation positive metastatic nonsmall cell lung cancer
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Flipped script for gefitinib: A reapproved tyrosine kinase inhibitor for first-line treatment of epidermal growth factor receptor mutation positive metastatic nonsmall cell lung cancer

机译：翻转吉替尼的脚本：一种用于一线术治疗表皮生长因子受体突变阳性转移性NONSMALL细胞肺癌的重新曝光的酪氨酸激酶抑制剂

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Purpose The approval history, pharmacology, pharmacokinetics, clinical trials, efficacy, dosing recommendations, drug interactions, safety, place in therapy, and economic considerations of gefitinib are reviewed. Summary Lung cancer is one of the most commonly diagnosed cancers and is the leading cause of cancer death. Platinum-based chemotherapy and tyrosine kinase inhibitors, such as erlotinib and afatinib, are recommended therapies for nonsmall cell lung cancer. The European Medicines Association based their approval of gefitinib on the randomized, multicenter Iressa Pan-Asia Study (IPASS, NCT00322452) and a single-arm study showing effectiveness in Caucasians (IFUM, NCT01203917). Both studies were recently referenced by the United States Food & Drug Administration to reapprove gefitinib for the first-line treatment of advanced nonsmall cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 substitution. Diarrhea, acneiform rash, and interstitial lung disease are known side effects of gefitinib. Conclusion Use of gefitinib for the first-line therapy of metastatic nonsmall cell lung cancer with epidermal growth factor receptor exon 19 deletions (residues 747–750) or exon 21 substitution mutation (L858R) is well-documented and supported.
机译：目的综述吉非替尼的批准历史、药理学、药代动力学、临床试验、疗效、给药建议、药物相互作用、安全性、治疗位置和经济考虑。肺癌是最常见的癌症之一，也是癌症死亡的主要原因。铂类化疗和酪氨酸激酶抑制剂，如厄洛替尼和阿法替尼，是非小细胞肺癌的推荐疗法。欧洲药物协会（European Medicines Association）批准吉非替尼的依据是随机、多中心的艾瑞莎泛亚研究（Iressa Pan Asia Study，IPASS，NCT00322452）和一项显示对高加索人有效的单臂研究（IFUM，NCT01203917）。美国食品和药物管理局最近引用了这两项研究，以重新批准吉非替尼用于表皮生长因子受体外显子19缺失或外显子21替换的晚期非小细胞肺癌的一线治疗。腹泻、痤疮样皮疹和间质性肺病是吉非替尼已知的副作用。结论使用吉非替尼一线治疗表皮生长因子受体外显子19缺失（残基747–750）或外显子21替换突变（L858R）的转移性非小细胞肺癌是有充分证据和支持的。

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