Kelley M C, Jones R C, Gupta R K, Yee R, Stern S, Wanek L, Morton D L
Roy E. Coats Research Laboratories, John Wayne Cancer Institute, Saint John's Health Center, Santa Monica, California 90404, USA.
Cancer. 1998 Oct 1;83(7):1355-61. doi: 10.1002/(sici)1097-0142(19981001)83:7<1355::aid-cncr12>3.0.co;2-3.
TA-90 is a tumor-associated antigen first identified in the urine and sera of patients with metastatic melanoma. In the early stages of disease, TA-90 is present in circulating immune complexes (ICs) that may be detected with an antigen specific enzyme-linked immunosorbent assay (ELISA). In this study, the authors evaluated the efficacy of the TA-90 IC assay in detecting subclinical metastasis of early stage melanoma and predicting the survival of patients with this disease.
Archival sera were collected preoperatively from 114 patients who underwent wide excision with or without regional lymphadenectomy in the treatment of clinical Stage I melanoma. Sera were analyzed for TA-90 IC in a blinded fashion, and results were correlated with the patient's clinical course as determined by database and chart review. Subclinical metastases were considered present at the time of surgery if the lymphadenectomy specimen was pathologically positive and/or the patient subsequently developed recurrence.
The TA-90 IC assay predicted subclinical metastasis in 43 of 56 patients (P < 0.0001), with 14 false-positive and 13 false-negative results. Sensitivity and specificity for the detection of occult metastasis were 77% and 76%, respectively. Positive and negative predictive values were 75% and 77%, respectively. Fifteen of 18 tumor positive regional lymph node basins (83%) and 34 of 46 recurrences (74%) were accurately predicted when considered independently (P < 0.004). Preoperative TA-90 IC status was also highly correlated with survival: 5-year overall and disease free survival rates were 63% and 46%, respectively, for the TA-90 IC positive group, compared with 88% and 82%, respectively, for the TA-90 IC negative group (P=0.0001). A multivariate analysis with standard prognostic variables identified preoperative TA-90 IC status as a strong, independent prognostic factor for both overall and disease free survival.
To the authors' knowledge, TA-90 is the first tumor marker that accurately predicts subclinical metastatic disease and survival for patients with early stage melanoma. For this reason, the TA-90 IC assay has the potential to improve dramatically the prognostic evaluation of patients with this disease. Its role in postoperative risk stratification and early detection of recurrence is being evaluated in a prospective study.
TA-90是一种肿瘤相关抗原，最初在转移性黑色素瘤患者的尿液和血清中被发现。在疾病早期，TA-90存在于循环免疫复合物（ICs）中，可通过抗原特异性酶联免疫吸附测定（ELISA）检测到。在本研究中，作者评估了TA-90 IC测定法在检测早期黑色素瘤亚临床转移及预测该疾病患者生存率方面的疗效。
术前收集了114例接受广泛切除（伴或不伴区域淋巴结清扫）以治疗临床I期黑色素瘤患者的存档血清。以盲法分析血清中的TA-90 IC，并将结果与通过数据库和病历审查确定的患者临床病程相关联。如果淋巴结清扫标本病理检查呈阳性和/或患者随后出现复发，则认为手术时存在亚临床转移。
TA-90 IC测定法在56例患者中的43例中预测了亚临床转移（P < 0.0001），有14例假阳性和13例假阴性结果。检测隐匿性转移的敏感性和特异性分别为77%和76%。阳性和阴性预测值分别为75%和77%。当单独考虑时，18个肿瘤阳性区域淋巴结组中的15个（83%）和46例复发中的34例（74%）被准确预测（P < 0.004）。术前TA-90 IC状态也与生存率高度相关：TA-90 IC阳性组的5年总生存率和无病生存率分别为63%和46%，而TA-90 IC阴性组分别为88%和82%（P = 0.0001）。对标准预后变量进行多变量分析后发现，术前TA-90 IC状态是总生存率和无病生存率的一个强大独立预后因素。
据作者所知，TA-90是首个能准确预测早期黑色素瘤患者亚临床转移疾病及生存率的肿瘤标志物。因此，TA-90 IC测定法有可能显著改善该疾病患者的预后评估。其在术后风险分层和复发早期检测中的作用正在一项前瞻性研究中进行评估。
