欧洲晚期结直肠癌EORTC临床试验筛查平台“SPECTAcolor”

G. Folprecht , M. Morfouace , M. Collienne , R. Salazar , A. Stein , E. Elez , A.D. Wagner , D. Arnold , C.H. Kohne , M. Ducreux , F. Lordick , B. Borelli , A. Stevovic , T. Gorlia , E. Fontana , D. Aust , V. Golfinopoulos , M. Moehler , S. Tejpar
{"title":"欧洲晚期结直肠癌EORTC临床试验筛查平台“SPECTAcolor”","authors":"G. Folprecht ,&nbsp;M. Morfouace ,&nbsp;M. Collienne ,&nbsp;R. Salazar ,&nbsp;A. Stein ,&nbsp;E. Elez ,&nbsp;A.D. Wagner ,&nbsp;D. Arnold ,&nbsp;C.H. Kohne ,&nbsp;M. Ducreux ,&nbsp;F. Lordick ,&nbsp;B. Borelli ,&nbsp;A. Stevovic ,&nbsp;T. Gorlia ,&nbsp;E. Fontana ,&nbsp;D. Aust ,&nbsp;V. Golfinopoulos ,&nbsp;M. Moehler ,&nbsp;S. Tejpar","doi":"10.1016/j.esmogo.2025.100168","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>The European Organisation for Research and Treatment of Cancer (EORTC) has established the Screening Platform for Efficient Clinical Trial Access for COLORectal Patients (SPECTAcolor), which provides centralized molecular testing to screen patients for and facilitate enrollment in molecular-based therapeutic trials.</div></div><div><h3>Materials and methods</h3><div>Patients with advanced or metastatic colorectal malignancies were recruited in 11 European countries. Patients’ paraffin-embedded material was tested for <em>KRAS</em><em>, NRAS, BRAF</em>, and <em>PI3K</em> microsatellite instability-high (MSI-H) (not routine at the time of recruitment) and later by a 300-gene next-generation sequencing panel. RNA profiling was carried out in a subset of patients. Results were reported to the centers and patients were followed up for their clinical outcome.</div></div><div><h3>Results</h3><div>Recruitment began in September 2013. The molecular screening program was completed at the end of 2015. A total of &gt;1000 patients were prospectively recruited into SPECTAcolor. Molecular and complete clinical/follow-up data are available for 845 metastatic colorectal cancer (CRC) patients. The simple κ coefficient for the agreement between local and central testing for <em>KRAS</em>, <em>NRAS</em>, and <em>BRAF</em> was 0.82-0.95, and the κ for MSI-H was 0.55. The median overall survival was 56.6 months. Patients with <em>BRCA</em>, <em>FGFR</em>, and <em>HER2</em> alterations had a trend toward shorter survival.</div></div><div><h3>Conclusion</h3><div>SPECTAcolor demonstrated that recruitment to an academic screening platform is feasible and that central (quality-assured) testing may remain necessary even for commonly tested markers. SPECTAcolor has generated a clinical and molecular dataset with associated samples for &gt;800 CRC patients for future academic research such as biomarker validation. Linking screening platforms to therapeutic trials and ensuring sustainability remain challenging.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100168"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"European screening platform for EORTC clinical trials in advanced colorectal cancer ‘SPECTAcolor’\",\"authors\":\"G. Folprecht ,&nbsp;M. Morfouace ,&nbsp;M. Collienne ,&nbsp;R. Salazar ,&nbsp;A. Stein ,&nbsp;E. Elez ,&nbsp;A.D. Wagner ,&nbsp;D. Arnold ,&nbsp;C.H. Kohne ,&nbsp;M. Ducreux ,&nbsp;F. Lordick ,&nbsp;B. Borelli ,&nbsp;A. Stevovic ,&nbsp;T. Gorlia ,&nbsp;E. Fontana ,&nbsp;D. Aust ,&nbsp;V. Golfinopoulos ,&nbsp;M. Moehler ,&nbsp;S. Tejpar\",\"doi\":\"10.1016/j.esmogo.2025.100168\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>The European Organisation for Research and Treatment of Cancer (EORTC) has established the Screening Platform for Efficient Clinical Trial Access for COLORectal Patients (SPECTAcolor), which provides centralized molecular testing to screen patients for and facilitate enrollment in molecular-based therapeutic trials.</div></div><div><h3>Materials and methods</h3><div>Patients with advanced or metastatic colorectal malignancies were recruited in 11 European countries. Patients’ paraffin-embedded material was tested for <em>KRAS</em><em>, NRAS, BRAF</em>, and <em>PI3K</em> microsatellite instability-high (MSI-H) (not routine at the time of recruitment) and later by a 300-gene next-generation sequencing panel. RNA profiling was carried out in a subset of patients. Results were reported to the centers and patients were followed up for their clinical outcome.</div></div><div><h3>Results</h3><div>Recruitment began in September 2013. The molecular screening program was completed at the end of 2015. A total of &gt;1000 patients were prospectively recruited into SPECTAcolor. Molecular and complete clinical/follow-up data are available for 845 metastatic colorectal cancer (CRC) patients. The simple κ coefficient for the agreement between local and central testing for <em>KRAS</em>, <em>NRAS</em>, and <em>BRAF</em> was 0.82-0.95, and the κ for MSI-H was 0.55. The median overall survival was 56.6 months. Patients with <em>BRCA</em>, <em>FGFR</em>, and <em>HER2</em> alterations had a trend toward shorter survival.</div></div><div><h3>Conclusion</h3><div>SPECTAcolor demonstrated that recruitment to an academic screening platform is feasible and that central (quality-assured) testing may remain necessary even for commonly tested markers. SPECTAcolor has generated a clinical and molecular dataset with associated samples for &gt;800 CRC patients for future academic research such as biomarker validation. Linking screening platforms to therapeutic trials and ensuring sustainability remain challenging.</div></div>\",\"PeriodicalId\":100490,\"journal\":{\"name\":\"ESMO Gastrointestinal Oncology\",\"volume\":\"8 \",\"pages\":\"Article 100168\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ESMO Gastrointestinal Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2949819825000378\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ESMO Gastrointestinal Oncology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2949819825000378","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

欧洲癌症研究和治疗组织(EORTC)已经建立了结肠直肠癌患者高效临床试验筛选平台(SPECTAcolor),该平台提供集中的分子检测来筛选患者并促进分子治疗试验的登记。材料和方法在11个欧洲国家招募晚期或转移性结直肠恶性肿瘤患者。对患者石蜡包埋材料进行KRAS、NRAS、BRAF和PI3K微卫星不稳定性高(MSI-H)检测(招募时不常规),然后通过300个基因的下一代测序小组进行检测。在一部分患者中进行了RNA分析。结果报告给中心,并随访患者的临床结果。2013年9月开始招募。分子筛选项目于2015年底完成。总共有1000名患者被前瞻性地招募到SPECTAcolor中。845例转移性结直肠癌(CRC)患者的分子和完整的临床/随访数据。KRAS、NRAS和BRAF的局部和中心检测的简单κ系数为0.82-0.95,MSI-H的κ系数为0.55。中位总生存期为56.6个月。BRCA、FGFR和HER2改变的患者有缩短生存期的趋势。结论:spectacolor表明,招募到学术筛选平台是可行的,即使对常用的检测标记物,中心(质量保证)检测也可能是必要的。SPECTAcolor已经为800名结直肠癌患者建立了一个临床和分子数据集,用于未来的学术研究,如生物标志物验证。将筛查平台与治疗试验联系起来并确保可持续性仍然具有挑战性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
European screening platform for EORTC clinical trials in advanced colorectal cancer ‘SPECTAcolor’

Background

The European Organisation for Research and Treatment of Cancer (EORTC) has established the Screening Platform for Efficient Clinical Trial Access for COLORectal Patients (SPECTAcolor), which provides centralized molecular testing to screen patients for and facilitate enrollment in molecular-based therapeutic trials.

Materials and methods

Patients with advanced or metastatic colorectal malignancies were recruited in 11 European countries. Patients’ paraffin-embedded material was tested for KRAS, NRAS, BRAF, and PI3K microsatellite instability-high (MSI-H) (not routine at the time of recruitment) and later by a 300-gene next-generation sequencing panel. RNA profiling was carried out in a subset of patients. Results were reported to the centers and patients were followed up for their clinical outcome.

Results

Recruitment began in September 2013. The molecular screening program was completed at the end of 2015. A total of >1000 patients were prospectively recruited into SPECTAcolor. Molecular and complete clinical/follow-up data are available for 845 metastatic colorectal cancer (CRC) patients. The simple κ coefficient for the agreement between local and central testing for KRAS, NRAS, and BRAF was 0.82-0.95, and the κ for MSI-H was 0.55. The median overall survival was 56.6 months. Patients with BRCA, FGFR, and HER2 alterations had a trend toward shorter survival.

Conclusion

SPECTAcolor demonstrated that recruitment to an academic screening platform is feasible and that central (quality-assured) testing may remain necessary even for commonly tested markers. SPECTAcolor has generated a clinical and molecular dataset with associated samples for >800 CRC patients for future academic research such as biomarker validation. Linking screening platforms to therapeutic trials and ensuring sustainability remain challenging.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信