Meng Qing H, Halfdanarson Thorvardur R, Bornhorst Joshua A, Jann Henning, Shaheen Shagufta, Shi Run Zhang, Schwabe Andrej, Stade Katrin, Halperin Daniel M
Department of Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, Minnesota.
Clin Cancer Res. 2024 Dec 16;30(24):5559-5567. doi: 10.1158/1078-0432.CCR-24-1875.
Gastroenteropancreatic neuroendocrine tumors (GEP-NET) are relatively indolent but can be more aggressive. The current recommendations for using serum chromogranin A (CgA) for patients with GEP-NET are equivocal. This study was designed to validate an automated CgA immunofluorescence assay for monitoring disease progression in patients with GEP-NET.
A prospective, multicenter, blinded observational study was designed to validate an automated CgA immunofluorescence assay for monitoring disease progression in patients with GEP-NET. Tumor progression was evaluated with 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.
A total of 153 patients with GEP-NET were enrolled. Using the prespecified cut-off of CgA change for tumor progression, specificity was 93.4% (95% confidence interval, 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 84.3% (80.5-87.6), and AUC 0.73 (0.67-0.79).
Changes in serial measurements of serum CgA had a favorable specificity and negative predictive value, making this test a useful adjunct to routine radiographic monitoring.
胃肠胰神经内分泌肿瘤（GEP-NET）相对惰性，但也可能更具侵袭性。目前关于GEP-NET患者使用血清嗜铬粒蛋白A（CgA）的建议并不明确。本研究旨在验证一种用于监测GEP-NET患者疾病进展的自动化CgA免疫荧光检测方法。
一项前瞻性、多中心、盲法观察性研究旨在验证一种用于监测GEP-NET患者疾病进展的自动化CgA免疫荧光检测方法。通过CT/MRI使用RECIST 1.1评估肿瘤进展。后续CgA浓度较先前CgA浓度升高≥50%且值>100 ng/mL被认为是阳性。
共纳入153例GEP-NET患者。使用预先设定的CgA变化临界值来判断肿瘤进展，特异性为93.4%（95%置信区间，90.4%-95.5%；P<0.001），敏感性为34.4%（25.6%-44.3%），阳性预测值为57.9%（45.0-69.8），阴性预测值为84.3%（80.5-87.6），曲线下面积为0.73（0.67-0.79）。
血清CgA连续测量值的变化具有良好的特异性和阴性预测值，使该检测成为常规影像学监测的有用辅助手段。
