PO.CL01.22 · 临床研究

血清神经元特异性烯醇化酶（NSE）作为中枢神经系统（CNS）转移的生物标志物：来自BrainStorm项目（Oncodistinct 006）的最新结果

Serum neuron-specific enolase (NSE) as a biomarker of central nervous system (CNS) metastases: Updated results from the BrainStorm program (Oncodistinct 006)

编号 1063 展板 3 时间 4/19 02:00–05:00 区域 Section 42 主讲 Nuria Kotecki, MD

分会场 Circulating Tumor Cells, Metastasis, and Dissemination Biology 1

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作者与单位 Authors & Affiliations

Soraia Lobo-Martins¹, Diogo Martins-Branco¹, Luca Arecco¹, Guilherme Nader-Marta², Andrea Gombos³, Anthony Gonçalves⁴, Eleonora Stephane de Maio D’Esposito⁵, Philippe Barthelemy⁶, Vincent Vanhaudenarde⁷, Florian Clatot⁸, Stéphane Holbrechts⁹, Francois P. Duhoux¹⁰, Edith Borcoman¹¹, Elisabeth Pop¹², Damien Parlier¹², Claire Cheymol¹³, Joseph Gligorov¹⁴, Hannelore Denys¹⁵, Paul Clement¹⁶, Caroline Duhem¹⁷, Lore Decoster¹⁸, Jean-Luc Canon¹⁹, Nadège Kindt²⁰, Françoise Rothé²¹, Ahmad H. Awada²², Nuria Kotecki³

¹Academic Trials Promoting Team (ATPT), Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Institut Jules Bordet, Brussels, Belgium,²Medical Oncology Department, Dana-Farber Cancer Institute, Boston, MA,³Medical Oncology Department, Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Institut Jules Bordet, Brussels, Belgium,⁴Medical Oncology, Institut Paoli-Calmettes, Marseille, France,⁵IUCT Oncopole-Institut Claudius Regaud, Toulouse, France,⁶Hôpitaux Universitaires de Strasbourg, Strasbourg, France,⁷Medical Oncology Department, CHU UCL Namur, site Ste-Elisabeth, Namur, Belgium,⁸Medical Oncology Department, Centre Henri Becquerel, Rouen, France,⁹CHU HELORA Hôpital de Mons site Kennedy, Mons, Belgium,¹⁰Medical Oncology Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium,¹¹Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France,¹²Clinical Trials Center (CTC), Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Institut Jules Bordet, Brussels, Belgium,¹³Centre Oscar Lambret, Lille, France,¹⁴APHP Tenon, IUC-UPMC, Sorbonne University, Paris, France,¹⁵Ghent University Hospital, Gent, Belgium,¹⁶UZ Leuven Gasthuisberg, Leuven, Belgium,¹⁷Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg,¹⁸UZ Brussel, Brussels, Belgium,¹⁹Oncologie Médicale, Grand Hôpital de Charleroi, Charleroi, Belgium,²⁰Laboratory of Clinical and Experimental Oncology, Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Institut Jules Bordet, Brussels, Belgium,²¹Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Institut Jules Bordet, Brussels, Belgium,²²Medical Oncology Department, Chirec Cancer Institute, Brussels, Belgium

摘要 Abstract

中文摘要

背景：血清NSE是一种神经元损伤标志物，可能作为实体瘤早期CNS受累的非侵入性指标。在此，我们探讨NSE在预测CNS转移发生中的作用。方法：BrainStorm项目是一项正在进行的国际、多中心前瞻性计划，旨在建立一个大型临床病理数据库和生物样本库以研究CNS转移。该项目正在招募新诊断的非CNS转移性实体瘤且CNS转移高风险的患者（pts）（A部分）或已有CNS转移的患者（B部分和C部分）。所有患者在基线时以及CNS转移前后定期接受血清学NSE检测。本次分析的主要目的是使用Mann-Whitney检验进行组间比较以及逻辑回归模型估计OR，评估基线NSE作为CNS发生预测生物标志物的作用（A部分对比B部分的受检患者）。结果：2020年11月至2025年6月期间，124例有可用NSE结果的患者被纳入该项目（A部分，n=73；B部分，n=51）——见表1。B部分的NSE水平显著高于A部分（中位数15.0（IQR 12.8-24.3）对比13.6（IQR 11.4-16.4）ng/mL；p=0.017）。在A部分中，基线NSE作为连续变量与CNS转移的发生显著相关（每增加1 ng/mL的OR为1.12；95% CI 1.02-1.22）。使用正常值上限作为分类临界值，基线NSE显示出CNS转移几率升高的趋势（OR 2.84；95%CI 0.60-13.39；8例CNS事件）。结论：这些发现支持NSE作为CNS转移发生的非侵入性预测生物标志物的潜在作用，尽管仍需在完全入组的BrainStorm项目中加以确认。表1——基线特征 A部分（N=73） B部分（N=51）年龄（岁），中位数（IQR） 58（48-66） 62（56-68）女性，n（%） 65（89） 40（78） ECOG-PS，n（%） 0 40（55） 10（20） 1 27（37） 28（55） 2 4（5） 9（18）癌症类型，n（%） TNBC 12（16） 8（16） HER2+ BC 45（62） 11（22） ER+/HER2- BC - 11（22） NSCLC 10（14） 13（25） SCLC 4（5） 3（6）黑色素瘤 2（3） 0（0）其他 - 5（10）转移部位数目，中位数（IQR） 2（1-2） 2（1-3）从非CNS转移至NSE的月数，中位数（IQR） 206（76-495） 178（26-972）从CNS转移至NSE的周数，中位数（IQR） - 15（10-26）基线血清NSE（ng/mL），中位数（IQR） 13.6（11.4-16.4） 15.0（12.8-24.3）

查看英文原文 English abstract

Background: Serum NSE, a marker of neuronal injury, may serve as a non-invasive indicator of early CNS involvement in solid tumors. Here, we explore the role of NSE for predicting development of CNS metastases. Methods: The BrainStorm program, is an ongoing international, multicenter prospective initiative, allowing the constitution of a large clinicopathological database and biobank to study CNS metastases. The program is recruiting patients (pts) with newly diagnosed non-CNS metastatic solid tumors at high risk of (Part A) or with CNS metastases (Part B and C). All pts undergo serologic NSE testing at baseline and at regular intervals pre- and post-CNS metastases. Main objective of the present analysis was to assess the role of baseline NSE as a predictive biomarker of CSN development from pts tested in Part A vs B, using Mann-Whitney test for group comparisons and logistic regression models to estimate OR. Results: 124 pts with available NSE results were included in the program from Nov/2020 to Jun/2025 (Part A, n=73; Part B, n=51) - Table 1. NSE levels were significatively higher in Part B than Part A (median 15.0 (IQR 12.8-24.3) vs 13.6 (IQR 11.4-16.4) ng/mL; p=0.017). In Part A, baseline NSE, as a continuous variable, was significantly associated with CNS metastases development (OR per ng/mL increase 1.12; 95% CI 1.02-1.22). Using the upper limit of normal as a categorical cut-off, baseline NSE showed a trend toward higher odds of CNS metastases (OR 2.84; 95%CI 0.60-13.39; 8 CNS events). Conclusions: These findings support a potential role for NSE as a non-invasive predictive biomarkers for the development of CNS metastases although confirmation in the fully accrued BrainStorm program is required. Table 1 - Baseline characteristics Part A (N=73) Part B (N=51) Age in years, median (IQR) 58 (48-66) 62 (56-68) Female, n (%) 65 (89) 40 (78) ECOG-PS, n (%) 0 40 (55) 10 (20) 1 27 (37) 28 (55) 2 4 (5) 9 (18) Cancer type, n (%) TNBC 12 (16) 8 (16) HER2+ BC 45 (62) 11 (22) ER+/HER2- BC - 11 (22) NSCLC 10 (14) 13 (25) SCLC 4 (5) 3 (6) Melanoma 2 (3) 0 (0) Other - 5 (10) No. metastatic sites, median (IQR) 2 (1-2) 2 (1-3) Months from non-CNS metastases to NSE, median (IQR) 206 (76-495) 178 (26-972) Weeks from CNS metastases to NSE, median (IQR) - 15 (10-26) Baseline serum NSE in ng/mL, median (IQR) 13.6 (11.4-16.4) 15.0 (12.8-24.3)

利益披露 Disclosure

S. Lobo-Martins, Roche ). AstraZeneca ). Novartis ). D. Martins-Branco, None. L. Arecco, Gilead ). AstraZeneca Travel. G. Nader-Marta, None.. A. Gombos, None.. A. Gonçalves, None.. E. Stephane de Maio D’Esposito, None.. P. Barthelemy, None.. V. Vanhaudenarde, None.. F. Clatot, None.. S. Holbrechts, None.. F. P. Duhoux, None.. E. Borcoman, None.. E. Pop, None.. D. Parlier, None.. C. Cheymol, None. H. Denys, PharmaMar Other, Consulting or Advisory Role. AstraZeneca Other, Consulting or Advisory Role. Eli Lilly Other, Consulting or Advisory Role. Novartis Other, Consulting or Advisory Role. Amgen Other, Consulting or Advisory Role. GSK Other, Consulting or Advisory Role. Seagen Other, Consulting or Advisory Role. MSD Other, Consulting or Advisory Role. Gilead Other, Consulting or Advisory Role. AbbVie Other, Consulting or Advisory Role. Menarini Other, Consulting or Advisory Role. Biopa Other, Consulting or Advisory Role. Incyclix Other, Consulting or Advisory Role. AstraZeneca Travel. MSD Travel. Gilead Travel. GSK Travel. Novartis Travel. P. Clement, None.. C. Duhem, None.. L. Decoster, None.. J. Canon, None.. N. Kindt, None.. F. Rothé, None.. A. H. Awada, None.. N. Kotecki, None.

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