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全面基因组分析在晚期实体瘤患者临床试验入组中的临床价值。

Clinical value of comprehensive genomic profiling on clinical trial enrollment for patients with advanced solid tumors.

作者信息

Huang Richard S P, Lee Jessica K, Lofgren Katherine T

机构信息

Foundation Medicine, Inc., Cambridge, MA, United States.

出版信息

Oncologist. 2025 Jul 4;30(7). doi: 10.1093/oncolo/oyae293.

DOI:10.1093/oncolo/oyae293
PMID:39471423
Abstract

The use of biomarker testing to inform treatment decisions has emerged as a standard of care in multiple cancer types. However, the rates of patients with genomic testing results in hand to inform treatment decision-making remain variable. Here, we studied the impact of comprehensive genomic profiling (CGP) on clinical trial enrollment rates in patients with advanced-stage non-small cell lung, colorectal, breast, and prostate cancer using a real-world clinicogenomic database. On average, clinical trial enrollment in the therapy line immediately after CGP report receipt was 5.4%, which represents a 3.0 percentage point increase compared to therapy lines preceding CGP report receipt, supporting a meaningful association between CGP report availability and increased clinical trial enrollment.

摘要

使用生物标志物检测来指导治疗决策已成为多种癌症类型的治疗标准。然而,手握基因组检测结果以指导治疗决策的患者比例仍然存在差异。在此,我们使用一个真实世界的临床基因组数据库,研究了全面基因组分析(CGP)对晚期非小细胞肺癌、结直肠癌、乳腺癌和前列腺癌患者临床试验入组率的影响。平均而言,在收到CGP报告后的紧接着的治疗线中,临床试验入组率为5.4%,与收到CGP报告之前的治疗线相比增加了3.0个百分点,这支持了CGP报告的可获得性与临床试验入组率增加之间存在有意义的关联。

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Clinical value of comprehensive genomic profiling on clinical trial enrollment for patients with advanced solid tumors.全面基因组分析在晚期实体瘤患者临床试验入组中的临床价值。
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本文引用的文献

1
Disparities According to Genetic Ancestry in the Use of Precision Oncology Assays.精准肿瘤学检测使用中基于遗传血统的差异
N Engl J Med. 2023 Jan 19;388(3):281-283. doi: 10.1056/NEJMc2213457.
2
Impact of a Clinical Genomics Program on Trial Accrual for Targeted Treatments: Practical Approach Overcoming Barriers to Accrual for Underserved Patients.临床基因组学计划对靶向治疗试验入组的影响:克服未满足患者入组障碍的实用方法。
JCO Clin Cancer Inform. 2022 Jul;6:e2200011. doi: 10.1200/CCI.22.00011.
3
Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors.
FoundationOne®CDx 的临床和分析验证,一种用于实体瘤的全面基因组分析检测方法。
PLoS One. 2022 Mar 16;17(3):e0264138. doi: 10.1371/journal.pone.0264138. eCollection 2022.
4
Clinical and analytical validation of FoundationOne Liquid CDx, a novel 324-Gene cfDNA-based comprehensive genomic profiling assay for cancers of solid tumor origin.FoundationOne Liquid CDx 的临床和分析验证,一种新型的基于 324 个基因 cfDNA 的用于实体瘤来源的癌症的全面基因组分析检测方法。
PLoS One. 2020 Sep 25;15(9):e0237802. doi: 10.1371/journal.pone.0237802. eCollection 2020.
5
Association of Patient Characteristics and Tumor Genomics With Clinical Outcomes Among Patients With Non-Small Cell Lung Cancer Using a Clinicogenomic Database.基于临床基因组数据库的非小细胞肺癌患者的患者特征和肿瘤基因组与临床结局的相关性分析。
JAMA. 2019 Apr 9;321(14):1391-1399. doi: 10.1001/jama.2019.3241.