Goodgame R, Kiefe C, Rose E, Sutton F, Brown J, Alpert E
Department of Medicine, Baylor College of Medicine, Houston, Texas 77030.
Cancer Res. 1993 Jun 15;53(12):2803-9.
A monoclonal antibody to colon carcinoma mucin was found to react with a colon carcinoma-associated carbohydrate epitope. This antibody was used to develop a quantitative solid phase immunoassay, M43. We prospectively and retrospectively evaluated the assay in patients with and without gastrointestinal carcinoma and compared the sensitivity and specificity with that of carcinoembryonic antigen (CEA) and CA 19-9. One hundred ninety-two patients (181 with no evidence of malignancy) referred for upper or lower gastrointestinal endoscopy were prospectively studied. Sera from 172 patients with histologically confirmed gastrointestinal adenocarcinoma were retrospectively studied. Optimal discrimination cutoffs for M43 (5 units/ml), CEA (5 ng/ml), and CA 19-9 (30 units/ml) were determined by receiver operating characteristic curves analysis. M43 was positive in 112 of 151 patients with colorectal carcinoma (sensitivity 74%) and was negative in 167 of 181 patients without carcinoma (specificity 92%). Sensitivity and specificity were 77% and 93% for CEA and 60% and 83% for CA 19-9. Sixty-four % of 73 patients with colorectal carcinoma limited to the bowel wall had a positive M43 with a mean value of 178 units/ml. Eighty-one % of 27 patients with nonhepatic metastasis had a positive M43 with a mean value of 223 units/ml. Eighty-four % of 51 patients with hepatic metastasis had a positive M43 assay with a mean value of 2532 units/ml. Sensitivity in these three groups was 67%, 82%, and 82%, respectively, for CEA and 43%, 68%, and 79%, respectively, for CA 19-9. Of 38 carcinoma patients with a negative CEA, 45% had a positive M43. No correlation between the levels of M43 and CEA in patients with colorectal carcinoma was found. We conclude that M43 is positive in most patients with colorectal carcinoma, even in early stages. As a diagnostic test, its sensitivity and specificity are equivalent to those of CEA. However, the M43 assay is measuring a tumor antigen which is fundamentally different from CEA and which is present in a high percentage of CEA-negative patients.
一种针对结肠癌粘蛋白的单克隆抗体被发现可与一种结肠癌相关的碳水化合物表位发生反应。该抗体被用于开发一种定量固相免疫测定法，即M43。我们对患有和未患有胃肠道癌的患者进行了前瞻性和回顾性评估该测定法，并将其敏感性和特异性与癌胚抗原（CEA）和CA 19-9的敏感性和特异性进行了比较。对192例因上消化道或下消化道内镜检查而转诊的患者（181例无恶性肿瘤证据）进行了前瞻性研究。对172例经组织学证实为胃肠道腺癌患者的血清进行了回顾性研究。通过受试者操作特征曲线分析确定了M43（5单位/毫升）、CEA（5纳克/毫升）和CA 19-9（30单位/毫升）的最佳区分临界值。在151例结直肠癌患者中，112例M43呈阳性（敏感性74%），在181例无癌患者中，167例M43呈阴性（特异性92%）。CEA的敏感性和特异性分别为77%和93%，CA 19-9的敏感性和特异性分别为60%和83%。73例局限于肠壁的结直肠癌患者中有64%的M43呈阳性，平均值为178单位/毫升。27例有非肝转移的患者中有81%的M43呈阳性，平均值为223单位/毫升。51例有肝转移的患者中有84%的M43测定呈阳性，平均值为2532单位/毫升。这三组中CEA的敏感性分别为67%、82%和82%，CA 19-9的敏感性分别为43%、68%和79%。在38例CEA阴性的癌症患者中，45%的M43呈阳性。未发现结直肠癌患者中M43水平与CEA水平之间存在相关性。我们得出结论，M43在大多数结直肠癌患者中呈阳性，即使在早期阶段也是如此。作为一种诊断测试，其敏感性和特异性与CEA相当。然而，M43测定法检测的是一种与CEA根本不同的肿瘤抗原，且在高比例的CEA阴性患者中存在。
