Hefler L, Tempfer C, Häusler G, Heinzl H, Kainz C
Klinische Abteilung für Gynäkologie und Geburtshilfe, Universitätsklinik für Frauenheilkunde, Wien.
Wien Klin Wochenschr. 1998 Oct 2;110(18):635-41.
The aim of the present study was to evaluate the clinical usefulness of the cytokeratin tumor marker M3/M21 as a screening, prognostic, and monitoring marker for ovarian cancer and as a predictive marker in patients with adnexal masses. In order to determine the specificity of the M3/M21 test we investigated M3/M21 serum levels in several benign conditions. The cytokeratin tumor markers M3/M21 and Tissue Polypeptide Specific Antigen (TPS) were also investigated in the follow-up of ovarian cancer patients. We evaluated M3/M21 serum levels in 75 patients suffering from ovarian cancer FIGO stages Ia to III, using a prototype immunoradiometric assay (IRMA). Sera of patients with benign cysts, endometriosis, pelvic inflammatory disease, inflammatory bowel disease and liver cirrhosis were evaluated in 90, 10, 38, 10, and 20 cases, respectively. Furthermore, we analyzed TPS serum levels by means of IRMA during the follow-up of 40 patients suffering from ovarian cancer. With a sensitivity of 57% and a specificity of 95% M3/M21 was not suitable as a screening marker for ovarian cancer. Although M3/M21 was able to discriminate between ovarian cancer and benign adnexal tumors (univariate logistic regression, p = 0.0003), M3/M21 did not provide additional information (in addition to CA 125) (multivariate logistic regression, p = 0.2). M3/M21 serum levels were elevated in several benign conditions such as liver cirrhosis and inflammatory bowel disease. In ovarian cancer patients elevated M3/M21 serum levels prior to therapy were associated with a poor overall and disease-free survival (log-rank test, p = 0.03, and log-rank test, p = 0.01, respectively). In patients with recurrent ovarian cancer M3/M21 and TPS showed median lead-time effects of 3.2 and 3.9 months, respectively. M3/M21, while obviously not suitable for screening or differential diagnosis of adnexal masses, could be useful as an additional prognostic factor. M3/M21 and TPS are valuable tumor markers in the follow-up of ovarian cancer patients.
本研究的目的是评估细胞角蛋白肿瘤标志物M3/M21作为卵巢癌筛查、预后及监测标志物以及附件肿块患者预测标志物的临床实用性。为确定M3/M21检测的特异性，我们研究了几种良性疾病患者的M3/M21血清水平。在卵巢癌患者的随访中，还对细胞角蛋白肿瘤标志物M3/M21和组织多肽特异性抗原（TPS）进行了研究。我们使用一种原型免疫放射分析（IRMA）方法评估了75例FIGO分期为Ia至III期的卵巢癌患者的M3/M21血清水平。分别对90例良性囊肿、10例子宫内膜异位症、38例盆腔炎、10例炎症性肠病和20例肝硬化患者的血清进行了评估。此外，我们在40例卵巢癌患者的随访期间通过IRMA分析了TPS血清水平。M3/M21作为卵巢癌筛查标志物，敏感性为57%，特异性为95%，并不适用。尽管M3/M21能够区分卵巢癌和良性附件肿瘤（单因素逻辑回归，p = 0.0003），但M3/M21并未提供额外信息（除CA 125外）（多因素逻辑回归，p = 0.2）。在几种良性疾病如肝硬化和炎症性肠病中，M3/M21血清水平也会升高。在卵巢癌患者中，治疗前M3/M21血清水平升高与总体生存率和无病生存率较差相关（对数秩检验，p分别为0.03和0.01）。在复发性卵巢癌患者中，M3/M21和TPS的中位提前期效应分别为3.2个月和3.9个月。M3/M21虽然显然不适用于附件肿块的筛查或鉴别诊断，但作为一个额外的预后因素可能有用。M3/M21和TPS在卵巢癌患者的随访中是有价值的肿瘤标志物。
