将循环嗜铬粒蛋白 A 作为类癌患者的监测生物标记物--CASPAR 研究

IF 10 1区医学 Q1 ONCOLOGY

Clinical Cancer Research Pub Date : 2024-10-25 DOI:10.1158/1078-0432.ccr-24-1875

Qing H. Meng, Thorvardur R. Halfdanarson, Joshua A. Bornhorst, Henning Jann, Shagufta Shaheen, Run Zhang Shi, Andrej Schwabe, Katrin Stade, Daniel M. Halperin

{"title":"将循环嗜铬粒蛋白 A 作为类癌患者的监测生物标记物--CASPAR 研究","authors":"Qing H. Meng, Thorvardur R. Halfdanarson, Joshua A. Bornhorst, Henning Jann, Shagufta Shaheen, Run Zhang Shi, Andrej Schwabe, Katrin Stade, Daniel M. Halperin","doi":"10.1158/1078-0432.ccr-24-1875","DOIUrl":null,"url":null,"abstract":"Purpose: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are relatively indolent but can be more aggressive. The current recommendations for the use of serum CgA for GEP-NET patients are equivocal. This study was designed to validate an automated CgA immunofluorescence assay for monitoring disease progression in GEP-NET patients. Patients and Methods: A prospective, multi-center blinded observational study was designed to validate an automated chromogranin A (CgA) immunofluorescence assay for monitoring disease progression in GEP-NET patients. Tumor progression was evaluated with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by CT/MRI. An increase ≥ 50% above the prior CgA concentration to a value &gt; 100 ng/mL in the following CgA concentration was considered positive. Results: 153 GEP-NET patients were enrolled. Using the pre-specified cut-off of CgA change for tumor progression, specificity was 93·4% (95%-CI: 90·4%—95·5%, p &lt; 0·001), sensitivity 34·4% (25·6%—44·3%), positive predictive value 57·9% (45·0—69·8), negative predictive value (NPV) 84·3% (80·5—87·6), and area under the curve 0·73 (0·67—0·79). Conclusions: Changes in serial measurements of serum CgA had a favorable specificity and NPV, making this test a useful adjunct to routine radiographic monitoring.","PeriodicalId":10279,"journal":{"name":"Clinical Cancer Research","volume":"236 1","pages":""},"PeriodicalIF":10.0000,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Circulating Chromogranin A as Surveillance Biomarker in Patients with Carcinoids – The CASPAR Study\",\"authors\":\"Qing H. Meng, Thorvardur R. Halfdanarson, Joshua A. Bornhorst, Henning Jann, Shagufta Shaheen, Run Zhang Shi, Andrej Schwabe, Katrin Stade, Daniel M. Halperin\",\"doi\":\"10.1158/1078-0432.ccr-24-1875\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Purpose: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are relatively indolent but can be more aggressive. The current recommendations for the use of serum CgA for GEP-NET patients are equivocal. This study was designed to validate an automated CgA immunofluorescence assay for monitoring disease progression in GEP-NET patients. Patients and Methods: A prospective, multi-center blinded observational study was designed to validate an automated chromogranin A (CgA) immunofluorescence assay for monitoring disease progression in GEP-NET patients. Tumor progression was evaluated with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by CT/MRI. An increase ≥ 50% above the prior CgA concentration to a value &gt; 100 ng/mL in the following CgA concentration was considered positive. Results: 153 GEP-NET patients were enrolled. Using the pre-specified cut-off of CgA change for tumor progression, specificity was 93·4% (95%-CI: 90·4%—95·5%, p &lt; 0·001), sensitivity 34·4% (25·6%—44·3%), positive predictive value 57·9% (45·0—69·8), negative predictive value (NPV) 84·3% (80·5—87·6), and area under the curve 0·73 (0·67—0·79). Conclusions: Changes in serial measurements of serum CgA had a favorable specificity and NPV, making this test a useful adjunct to routine radiographic monitoring.\",\"PeriodicalId\":10279,\"journal\":{\"name\":\"Clinical Cancer Research\",\"volume\":\"236 1\",\"pages\":\"\"},\"PeriodicalIF\":10.0000,\"publicationDate\":\"2024-10-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Cancer Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1158/1078-0432.ccr-24-1875\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Cancer Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1158/1078-0432.ccr-24-1875","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

目的：胃肠胰神经内分泌肿瘤（GEP-NET）相对较轻，但也可能更具侵袭性。目前对 GEP-NET 患者使用血清 CgA 的建议并不明确。本研究旨在验证用于监测 GEP-NET 患者疾病进展的自动 CgA 免疫荧光测定。患者和方法：一项前瞻性、多中心盲法观察研究旨在验证用于监测 GEP-NET 患者疾病进展的自动嗜铬粒蛋白 A (CgA) 免疫荧光测定。肿瘤进展根据实体瘤反应评估标准（RECIST）1.1通过CT/MRI进行评估。如果CgA浓度比之前增加≥50%，达到100 ng/mL，则视为阳性。结果153名GEP-NET患者入选。使用预先指定的肿瘤进展CgA变化临界值，特异性为93-4%（95%-CI：90-4%-95-5%，p< 0-001），灵敏度为34-4%（25-6%-44-3%），阳性预测值为57-9%（45-0-69-8），阴性预测值（NPV）为84-3%（80-5-87-6），曲线下面积为0-73（0-67-0-79）。结论血清 CgA 连续测量值的变化具有良好的特异性和 NPV，使该检验成为常规放射学监测的有效辅助手段。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Circulating Chromogranin A as Surveillance Biomarker in Patients with Carcinoids – The CASPAR Study

Purpose: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are relatively indolent but can be more aggressive. The current recommendations for the use of serum CgA for GEP-NET patients are equivocal. This study was designed to validate an automated CgA immunofluorescence assay for monitoring disease progression in GEP-NET patients. Patients and Methods: A prospective, multi-center blinded observational study was designed to validate an automated chromogranin A (CgA) immunofluorescence assay for monitoring disease progression in GEP-NET patients. Tumor progression was evaluated with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by CT/MRI. An increase ≥ 50% above the prior CgA concentration to a value > 100 ng/mL in the following CgA concentration was considered positive. Results: 153 GEP-NET patients were enrolled. Using the pre-specified cut-off of CgA change for tumor progression, specificity was 93·4% (95%-CI: 90·4%—95·5%, p < 0·001), sensitivity 34·4% (25·6%—44·3%), positive predictive value 57·9% (45·0—69·8), negative predictive value (NPV) 84·3% (80·5—87·6), and area under the curve 0·73 (0·67—0·79). Conclusions: Changes in serial measurements of serum CgA had a favorable specificity and NPV, making this test a useful adjunct to routine radiographic monitoring.

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

Clinical Cancer Research 医学-肿瘤学

CiteScore

20.10

自引率

1.70%

发文量

1207

审稿时长

2.1 months

期刊介绍： Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.