NCCN 肿瘤学研究计划的调查员指导委员会和 NCCN 最佳实践委员会的分子特征分析调查。

NCCN Oncology Research Program's Investigator Steering Committee and NCCN Best Practices Committee Molecular Profiling Surveys.

机构信息

From UC San Diego Moores Cancer Center, San Diego, California; Stanford Cancer Institute, Stanford, California; Fox Chase Cancer Center, Philadelphia, Pennsylvania; Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah; Vanderbilt-Ingram Cancer Center, Nashville, Tennessee; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, Ohio; Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Washington University, St. Louis, Missouri; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland; City of Hope Comprehensive Cancer Center, Los Angeles, California; The West Clinic, Memphis, Tennessee; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California; Johns Hopkins University School of Medicine, Baltimore, Maryland; and Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance.

出版信息

J Natl Compr Canc Netw. 2015 Nov;13(11):1337-46. doi: 10.6004/jnccn.2015.0163.

DOI:10.6004/jnccn.2015.0163

PMID:26553764

Abstract

BACKGROUND

With advances such as next-generation sequencing (NGS) increasing understanding of the basis of cancer and its response to treatment, NCCN believes it is important to understand how molecular profiling/diagnostic testing is being performed and used at NCCN Member Institutions and their community affiliates.

METHODS

The NCCN Oncology Research Program's Investigator Steering Committee and the NCCN Best Practices Committee gathered baseline information on the use of cancer-related molecular testing at NCCN Member Institutions and community members of the NCCN Affiliate Research Consortium through 2 separate surveys distributed in December 2013 and September 2014, respectively.

RESULTS

A total of 24 NCCN Member Institutions and 8 affiliate sites provided quantitative and qualitative data. In the context of these surveys, "molecular profiling/diagnostics" was defined as a panel of at least 10 genes examined as a diagnostic DNA test in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

CONCLUSIONS

Results indicated that molecular profiling/diagnostics are used at 100% of survey respondents' institutions to make patient care decisions. However, challenges relating to reimbursement, lack of data regarding actionable targets and targeted therapies, and access to drugs on or off clinical trials were cited as barriers to integration of molecular profiling into patient care. Frameworks for using molecular diagnostic results based on levels of evidence, alongside continued research into the predictive value of biomarkers and targeted therapies, are recommended to advance understanding of the role of genomic biomarkers. Greater evidence and consensus regarding the clinical and cost-effectiveness of molecular profiling may lead to broader insurance coverage and increased integration into patient care.

摘要

背景

随着下一代测序（NGS）等技术的进步，人们对癌症的基础及其对治疗的反应有了更深入的了解，NCCN 认为了解 NCCN 成员机构及其社区附属机构如何进行和使用分子谱分析/诊断测试非常重要。

方法

NCCN 肿瘤学研究计划的调查员指导委员会和 NCCN 最佳实践委员会通过 2013 年 12 月和 2014 年 9 月分别分发的 2 份独立调查，收集了 NCCN 成员机构和 NCCN 附属研究联盟社区成员使用癌症相关分子测试的基线信息。

结果

共有 24 家 NCCN 成员机构和 8 个附属站点提供了定量和定性数据。在这些调查中，“分子谱分析/诊断”被定义为在临床实验室改进修正案（CLIA）认证实验室中作为诊断性 DNA 测试检查的至少 10 个基因的一组。

结论

结果表明，分子谱分析/诊断在调查受访者的机构中 100%用于做出患者护理决策。然而，与报销、缺乏关于可操作靶点和靶向治疗的数据以及临床试验内外药物的获取相关的挑战被认为是将分子谱分析纳入患者护理的障碍。建议建立基于证据水平使用分子诊断结果的框架，同时继续研究生物标志物和靶向治疗的预测价值，以推进对基因组生物标志物作用的理解。更多关于分子谱分析的临床和成本效益的证据和共识可能会导致更广泛的保险覆盖范围，并增加其在患者护理中的整合。