Dolscheid-Pommerich Ramona C, Keyver-Paik Mignon, Hecking Thomas, Kuhn Walther, Hartmann Gunther, Stoffel-Wagner Birgit, Holdenrieder Stefan
1 Department of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.
2 Department of Gynecology and Obstetrics, University Hospital Bonn, Bonn, Germany.
Tumour Biol. 2017 Oct;39(10):1010428317730246. doi: 10.1177/1010428317730246.
Evidence is sparse regarding the clinical performance of luminescent oxygen channeling immunoassays-based tumor marker assays in gynecological cancer. Analyzing serum samples of 336 patients with Dimension™Vista1500, we investigated the diagnostic power of carbohydrate antigen 15-3, carbohydrate antigen 125, carcinoembryonic antigen, carbohydrate antigen 19-9, and alpha-fetoprotein in patients suffering from different types of gynecological cancer and precancerous gynecological diseases and compared findings to appropriate control groups. The cohort comprised 177 female patients with gynecological cancers (73 breast, 22 cervical, 16 endometrial, 17 vulva, and 49 ovarian cancers), 26 patients with precancerous gynecological diseases (11 vulva, 4 cervical, and 10 breast), 109 patients with benign gynecological diseases, and 24 healthy controls. Discriminative power was assessed by areas under the curve in receiver operating characteristic curves, and sensitivities were determined at a fixed specificity of 95%. Levels of biomarkers in healthy controls were in the expected ranges and a discriminative power between gynecological cancers and healthy controls was observed for several tumor markers. Established tumor type-associated markers were elevated in specific gynecological cancers and benign controls as well as within precancerous gynecological diseases and healthy control group. In ovarian cancer, carbohydrate antigen 125 and carbohydrate antigen 15-3 were significantly elevated compared to the respective benign diseases. Carbohydrate antigen 125 was the most conclusive marker (area under the curve = 0.86% and 77.6% sensitivity at 95% specificity). In breast cancer, carcinoembryonic antigen and carbohydrate antigen 15-3 were significantly higher than in the respective benign diseases. Carcinoembryonic antigen achieved the most conclusive area under the curve (0.65) with 31.5% sensitivity at 95% specificity. None of the investigated markers was found to be of value in discriminating benign and malignant cervical diseases. Carcinoembryonic antigen and alpha-fetoprotein distinguished precancerous breast and vulva diseases from healthy controls. These findings show that luminescent oxygen channeling immunoassays-based tumor marker assays provide reliable results in routine diagnostics.
关于基于发光氧通道免疫分析的肿瘤标志物检测在妇科癌症中的临床性能，证据稀少。我们使用Dimension™Vista1500分析了336例患者的血清样本，研究了糖类抗原15-3、糖类抗原125、癌胚抗原、糖类抗原19-9和甲胎蛋白在不同类型妇科癌症和癌前妇科疾病患者中的诊断能力，并将结果与适当的对照组进行比较。该队列包括177例患有妇科癌症的女性患者（73例乳腺癌、22例宫颈癌、16例子宫内膜癌、17例外阴癌和49例卵巢癌）、26例患有癌前妇科疾病的患者（11例外阴疾病、4例宫颈疾病和10例乳腺疾病）、109例患有良性妇科疾病的患者和24例健康对照。通过受试者操作特征曲线下的面积评估鉴别能力，并在固定特异性为95%时确定敏感性。健康对照中生物标志物的水平在预期范围内，并且观察到几种肿瘤标志物在妇科癌症和健康对照之间具有鉴别能力。既定的肿瘤类型相关标志物在特定的妇科癌症和良性对照中以及在癌前妇科疾病和健康对照组中均升高。在卵巢癌中，与各自的良性疾病相比，糖类抗原125和糖类抗原15-3显著升高。糖类抗原125是最具决定性的标志物（曲线下面积 = 0.86%，在95%特异性时敏感性为77.6%）。在乳腺癌中，癌胚抗原和糖类抗原15-3显著高于各自的良性疾病。癌胚抗原在曲线下面积方面最具决定性（0.65），在95%特异性时敏感性为31.5%。未发现所研究的标志物在鉴别良性和恶性宫颈疾病方面有价值。癌胚抗原和甲胎蛋白将癌前乳腺和外阴疾病与健康对照区分开来。这些发现表明，基于发光氧通道免疫分析的肿瘤标志物检测在常规诊断中提供了可靠的结果。
