American Society of Clinical Oncology Provisional Clinical Opinion: Testing for KRAS Gene Mutations in Patients With Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy
American Society of Clinical Oncology Provisional Clinical Opinion: Testing for KRAS Gene Mutations in Patients With Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy
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DOI：
10.1200/jco.2009.21.9170
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发表时间：
2009-04-20
影响因子：
45.3
通讯作者：
Schilsky, Richard L.
中科院分区：
文献类型：
--
作者：
Allegra, Carmen J.;Jessup, J. Milburn;Schilsky, Richard L.
目的：美国临床肿瘤学会（ASCO）临时临床意见（PCO），在发表或展示可能改变实践的主要研究数据后，为ASCO的肿瘤学家提供及时的临床指导。本PCO探讨了KRAS基因突变检测在转移性结直肠癌患者中的应用，以预测抗表皮生长因子受体（抗egfr）单克隆抗体（MoAb）治疗西妥昔单抗或帕尼单抗的反应（见注）。临床背景最近的II期和III期临床试验结果表明，转移性结直肠癌患者可以从针对EGFR的单克隆抗体治疗中获益，无论是作为单一疗法还是与化疗联合使用。这些试验数据的回顾性亚组分析强烈表明，在密码子12或13中检测到KRAS突变的患者不能从这种治疗中获益。最近DataFive的西妥昔单抗或帕尼单抗随机对照试验评估了转移性结直肠癌患者的预后与KRAS突变状态的关系，即未检测到突变（野生型）或异常（突变）。另外五项单臂研究根据KRAS状态回顾性评估了肿瘤反应。基于对相关文献的系统回顾，所有需要抗egfr抗体治疗的转移性结直肠癌患者都应该在clia认可的实验室进行肿瘤KRAS突变检测。如果检测到KRAS密码子12或13突变，则转移性结直肠癌患者不应将抗egfr抗体治疗作为其治疗的一部分。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。中华临床杂志，27(2):391 - 396。(C) 2009年美国临床肿瘤学会
PurposeAn American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO), offers timely clinical direction to ASCO's oncologists following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the utility of KRAS gene mutation testing in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody (MoAb) therapy with cetuximab or panitumumab (see Note).Clinical ContextRecent results from phase II and III clinical trials demonstrate that patients with metastatic colorectal cancer benefit from therapy with monoclonal antibodies directed against the EGFR, when used either as monotherapy or combined with chemotherapy. Retrospective subset analyses of the data from these trials strongly suggest that patients who have KRAS mutations detected in codon 12 or 13 do not benefit from this therapy.Recent DataFive randomized controlled trials of cetuximab or panitumumab have evaluated outcomes for patients with metastatic colorectal carcinoma in relation to KRAS mutational status as no mutation detected (wild type) or abnormal (mutated). Another five single-arm studies have retrospectively evaluated tumor response according to KRAS status.Provisional Clinical OpinionBased on systematic reviews of the relevant literature, all patients with metastatic colorectal carcinoma who are candidates for anti-EGFR antibody therapy should have their tumor tested for KRAS mutations in a CLIA-accredited laboratory. If KRAS mutation in codon 12 or 13 is detected, then patients with metastatic colorectal carcinoma should not receive anti-EGFR antibody therapy as part of their treatment.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. Due to 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. J Clin Oncol 27: 2091-2096. (C) 2009 by American Society of Clinical Oncology