非小细胞肺癌患者既往单基因检测对综合基因组分析结果的影响

IF 3.2 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2024-06-01 Epub Date: 2024-03-19 DOI:10.1007/s40487-024-00270-x

Mary K Nesline, Vivek Subbiah, Rebecca A Previs, Kyle C Strickland, Heidi Ko, Paul DePietro, Michael D Biorn, Maureen Cooper, Nini Wu, Jeffrey Conroy, Sarabjot Pabla, Shengle Zhang, Zachary D Wallen, Pratheesh Sathyan, Kamal Saini, Marcia Eisenberg, Brian Caveney, Eric A Severson, Shakti Ramkissoon

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引用次数: 0

摘要

简介：在对非小细胞肺癌（NSCLC）患者进行治疗管理时，建议对指南推荐的生物标志物进行基于组织的广泛分子分析。然而，实践中的差异会影响是否对所有指定的生物标志物进行检测。我们的目的是评估普通单基因检测（SGT）对随后的非小细胞肺癌综合基因组图谱（CGP）检测结果的影响：我们前瞻性地联系了为 NSCLC 患者开具指南推荐生物标志物 SGT 检测单的肿瘤学家（2022 年 5 月至 12 月），并在收到 SGT 阴性结果后为每位患者提供 CGP（DNA 和 RNA 测序）服务，或代替 SGT。我们描述了SGT的模式，并比较了CGP的完成率、周转时间，以及对SGT结果阴性和未阴性的NSCLC患者推荐的生物标记物检测：大于 80 个社区诊所的肿瘤学家为 561 名 NSCLC 患者开具了 CGP 订单；135 名患者（27%）首先从 30 种不同的 SGT 组合中获得了阴性结果；84% 的订单包括 ALK、表皮生长因子受体和 PD-L1，而只有 3% 的订单包括指南推荐基因的所有可用 SGT。在 SGT 结果为阴性的患者中，90% 的患者尝试使用相同的组织标本进行 CGP。此外，因组织不足（17% 对 7%）、DNA 测序失败（13% 对 8%）和周转时间超过 14 天（62% 对 29%）而取消 CGP 订单的患者也明显多于只进行 CGP 的患者。在既往SGT阴性的患者中，46%的推荐生物标记物CGP结果呈阳性，包括ALK和表皮生长因子受体以外基因的可靶基因组变异，如ERBB2、KRAS（非G12C）、MET（第14外显子跳越）、NTRK2/3和RET：对于 NSCLC 患者来说，初次使用 SGT 会增加后续 CGP 检测的取消率、周转时间以及因组织不足而导致指南推荐的生物标志物分子图谱不完整的可能性。

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The Impact of Prior Single-Gene Testing on Comprehensive Genomic Profiling Results for Patients with Non-Small Cell Lung Cancer.

Introduction: Tissue-based broad molecular profiling of guideline-recommended biomarkers is advised for the therapeutic management of patients with non-small cell lung cancer (NSCLC). However, practice variation can affect whether all indicated biomarkers are tested. We aimed to evaluate the impact of common single-gene testing (SGT) on subsequent comprehensive genomic profiling (CGP) test outcomes and results in NSCLC.

Methods: Oncologists who ordered SGT for guideline-recommended biomarkers in NSCLC patients were prospectively contacted (May-December 2022) and offered CGP (DNA and RNA sequencing), either following receipt of negative SGT findings, or instead of SGT for each patient. We describe SGT patterns and compare CGP completion rates, turnaround time, and recommended biomarker detection for NSCLC patients with and without prior negative SGT results.

Results: Oncologists in > 80 community practices ordered CGP for 561 NSCLC patients; 135 patients (27%) first had negative results from 30 different SGT combinations; 84% included ALK, EGFR and PD-L1, while only 3% of orders included all available SGTs for guideline-recommended genes. Among patients with negative SGT results, CGP was attempted using the same tissue specimen 90% of the time. There were also significantly more CGP order cancellations due to tissue insufficiency (17% vs. 7%), DNA sequencing failures (13% vs. 8%), and turnaround time > 14 days (62% vs. 29%) than among patients who only had CGP. Forty-six percent of patients with negative prior SGT had positive CGP results for recommended biomarkers, including targetable genomic variants in genes beyond ALK and EGFR, such as ERBB2, KRAS (non-G12C), MET (exon 14 skipping), NTRK2/3, and RET .

Conclusion: For patients with NSCLC, initial use of SGT increases subsequent CGP test cancellations, turnaround time, and the likelihood of incomplete molecular profiling for guideline-recommended biomarkers due to tissue insufficiency.

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. 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