...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>BMC Medical Informatics and Decision Making >Treatment recommendations to cancer patients in the context of FDA guidance for next generation sequencing
【24h】

Treatment recommendations to cancer patients in the context of FDA guidance for next generation sequencing

机译：在FDA下一代测序指南的指导下为癌症患者提供治疗建议

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Regulatory approval of next generation sequencing (NGS) by the FDA is advancing the use of genomic-based precision medicine for the therapeutic management of cancer as standard care. Recent FDA guidance for the classification of genomic variants based on clinical evidence to aid clinicians in understanding the actionability of identified variants provided by comprehensive NGS panels has also been set forth. In this retrospective analysis, we interpreted and applied the FDA variant classification guidance to comprehensive NGS testing performed for advanced cancer patients and assessed oncologist agreement with NGS test treatment recommendations. NGS comprehensive genomic profiling was performed in a CLIA certified lab (657 completed tests for 646 patients treated at Roswell Park Comprehensive Cancer Center) between June 2016 and June 2017. Physician treatment recommendations made within 120?days post-test were gathered from tested patients’ medical records and classified as targeted therapy, precision medicine clinical trial, immunotherapy, hormonal therapy, chemotherapy/radiation, surgery, transplant, or non-therapeutic (hospice, surveillance, or palliative care). Agreement between NGS test report targeted therapy recommendations based on the FDA variant classification and physician targeted therapy treatment recommendations were evaluated. Excluding variants contraindicating targeted therapy (i.e., KRAS or NRAS mutations), at least one variant with FDA level 1 companion diagnostic supporting evidence as the most actionable was identified in 14% of tests, with physicians most frequently recommending targeted therapy (48%) for patients with these results. This stands in contrast to physicians recommending targeted therapy based on test results with FDA level 2 (practice guideline) or FDA level 3 (clinical trial or off label) evidence as the most actionable result (11 and 4%, respectively). We found an appropriate “dose-response” relationship between the strength of clinical evidence supporting biomarker-directed targeted therapy based on application of FDA guidance for NGS test variant classification, and subsequent treatment recommendations made by treating physicians. In view of recent changes at FDA, it is paramount to define regulatory grounds and medical policy coverage for NGS testing based on this guidance.
机译：FDA批准了下一代测序（NGS）的法规，正在促进基于基因组的精密药物在癌症治疗管理中的应用。 FDA还提出了基于临床证据对基因组变异进行分类的最新FDA指南，以帮助临床医生了解由综合NGS专家组提供的已鉴定变异的可操作性。在这项回顾性分析中，我们将FDA变体分类指南解释并应用到了针对晚期癌症患者的全面NGS测试中，并评估了肿瘤学家对NGS测试治疗建议的认可。在2016年6月至2017年6月之间，在CLIA认证的实验室中对NGS进行了全面的基因组分析（在罗斯韦尔公园综合癌症中心对646例患者进行了657项完整测试）。在测试后120天内提出的医师治疗建议来自被测患者。病历，分为目标疗法，精准医学临床试验，免疫疗法，激素疗法，化学疗法/放射疗法，手术，移植或非治疗（临终关怀，监视或姑息治疗）。评估了基于FDA变体分类的NGS测试报告针对性治疗建议与医师针对性治疗建议之间的一致性。除禁止靶向治疗的变体（即KRAS或NRAS突变）外，在14％的测试中至少发现了一种具有FDA 1级伴随诊断支持证据的变体最有作用，而医生最常推荐针对以下治疗的靶向治疗（48％）这些结果的患者。这与医师建议根据具有FDA 2级（实践准则）或FDA 3级（临床试验或不合格）证据的测试结果进行靶向治疗为最可操作的结果（分别为11％和4％）相反。我们在基于FDA指导NGS测试变体分类的应用的基础上，支持生物标志物定向治疗的临床证据的强度与治疗医生提出的后续治疗建议之间，找到了适当的“剂量反应”关系。鉴于FDA最近的变化，基于此指南定义NGS测试的法规依据和医疗政策覆盖范围至关重要。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号