American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients With Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy
American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients With Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy
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DOI：
10.1200/jco.2010.31.8923
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发表时间：
2011-05-20
影响因子：
45.3
通讯作者：
Giaccone, Giuseppe
中科院分区：
文献类型：
--
作者：
Keedy, Vicki Leigh;Temin, Sarah;Giaccone, Giuseppe
目的：美国临床肿瘤学会（ASCO）临时临床意见（PCO）在发表或介绍可能改变实践的主要研究数据后，为ASCO会员提供及时的临床指导。本PCO探讨了使用表皮生长因子受体（EGFR）突变检测晚期非小细胞肺癌（NSCLC）患者的临床应用，以预测服用一线EGFR酪氨酸激酶抑制剂（TKI）的益处。临床背景EGFR突变的NSCLC患者对EGFR TKIs吉非替尼和厄洛替尼的部分应答率明显更高。在美国，大约15%的肺腺癌患者携带激活EGFR突变。EGFR突变检测在学术医疗中心和一些社区实践中广泛应用。到目前为止，还没有证据表明根据进行这种测试来选择治疗会使总生存期（OS）受益。最近的数据：一项大型III期试验（易瑞沙泛亚研究[IPASS]试验），三项较小的III期随机对照试验，以无进展生存期为主要终点，一项小型III期试验，以OS为主要终点，均涉及一线EGFR TKIs和化疗双药，构成了该PCO的基础。根据5项III期随机对照试验的结果，考虑接受EGFR TKI一线治疗的非小细胞肺癌患者（之前未接受化疗或EGFR TKI的患者）应进行肿瘤EGFR突变检测，以确定EGFR TKI或化疗是否是合适的一线治疗。ASCO的临时临床意见（PCOs）反映了专家在撰写时基于临床证据和文献的共识，旨在帮助医生进行临床决策，并确定进一步研究的问题和环境。由于肿瘤学科学信息的快速流动，自PCO提交出版以来，可能已经出现了新的证据。PCOs没有持续更新，可能不能反映最新的证据。PCOs不能解释患者之间的个体差异，不能被认为包括所有适当的护理方法或排除其他治疗。治疗医生或其他卫生保健提供者有责任依靠独立的经验和对患者的了解，确定对患者的最佳治疗方案。因此，遵守任何PCO都是自愿的，医生根据每位患者的个人情况作出最终决定。ASCO PCOs描述了临床实践中程序和疗法的使用，不能被认为适用于临床试验背景下这些干预措施的使用。对于因使用ASCO的PCOs而引起的或与之相关的人员或财产的任何伤害或损害，或任何错误或遗漏，ASCO不承担任何责任。
PurposeAn American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the clinical utility of using epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small-cell lung cancer (NSCLC) to predict the benefit of taking a first-line EGFR tyrosine kinase inhibitor (TKI).Clinical ContextPatients with EGFR-mutated NSCLC have a significantly higher rate of partial responses to the EGFR TKIs gefitinib and erlotinib. In the United States, approximately 15% of patients with adenocarcinoma of the lung harbor activating EGFR mutations. EGFR mutation testing is widespread at academic medical centers and in some locales in community practice. As of yet, there is no evidence of an overall survival (OS) benefit from selecting treatment based on performing this testing.Recent DataOne large phase III trial (the Iressa Pan-Asia Study [IPASS] trial), three smaller phase III randomized controlled trials using progression-free survival as the primary end point, and one small phase III trial with OS as the primary end point, all involving first-line EGFR TKIs and chemotherapy doublets, form the basis of this PCO.Provisional Clinical OpinionOn the basis of the results of five phase III randomized controlled trials, patients with NSCLC who are being considered for first-line therapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy.NOTE.ASCO's provisional clinical opinions (PCOs) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and settings for further research. Because of the rapid flow of scientific information in oncology, new evidence may have emerged since the time a PCO was submitted for publication. PCOs are not continually updated and may not reflect the most recent evidence. PCOs cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any PCO is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO PCOs describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's PCOs, or for any errors or omissions.