Soloway M S, Briggman V, Carpinito G A, Chodak G W, Church P A, Lamm D L, Lange P, Messing E, Pasciak R M, Reservitz G B, Rukstalis D B, Sarosdy M F, Stadler W M, Thiel R P, Hayden C L
University of Miami, Florida, USA.
J Urol. 1996 Aug;156(2 Pt 1):363-7. doi: 10.1097/00005392-199608000-00008.
We evaluated the ability of an immunoassay for nuclear matrix protein 22 (NMP22 test kit) to predict the subsequent disease status of patients with transitional cell carcinoma of the urinary tract at approximately 10 days after transurethral resection of bladder tumor.
A total of 90 patients with transitional cell carcinoma provided voided urine samples at least 5 days postoperatively. NMP22 was determined using a commercial test kit. At initial cystoscopic examination 3 to 6 months later the disease status was recorded, and the NMP22 values before and after transurethral resection of bladder tumor were compared.
Of 125 followup cystoscopic examinations (60 patients had 1, 26 had 2, 3 had 3 and 1 had 4 recurrences) transitional cell carcinoma was pathologically confirmed in 33. No malignancy was present at 79 examinations (if tumor was seen endoscopically, pathological evaluation indicated atypia, dysplasia or no abnormality). NMP22 values in these 2 populations were significantly different (malignancy median 20.81 units per ml. and no malignancy median 5.72 units per ml., Mann-Whitney U test for differences between 2 medians p = 0.00005). Of the 33 recurrences 23 (70%) had NMP22 values greater than the reference range (10 units per ml.). Additionally, NMP22 identified all 6 subjects (100%) who had invasive disease 3 to 6 months later. Of 72 patients with NMP22 less than 10 units per ml. 62 (86%) had no malignancy at subsequent cystoscopy.
NMP22 was highly predictive of tumor status at followup cystoscopy. This quantitative, noninvasive assay, with high negative predictive value (86%) and sensitivity to detect malignancy (100% for invasive disease and 70% overall), may be a helpful adjunct to cytology and endoscopy for monitoring disease status after endoscopic tumor resection.
我们评估了一种核基质蛋白22免疫测定法(NMP22检测试剂盒)在经尿道膀胱肿瘤切除术后约10天预测尿路移行细胞癌患者后续疾病状态的能力。
总共90例移行细胞癌患者在术后至少5天提供了晨尿样本。使用商用检测试剂盒测定NMP22。在3至6个月后的初次膀胱镜检查时记录疾病状态,并比较经尿道膀胱肿瘤切除术前和术后的NMP22值。
在125次随访膀胱镜检查中(60例患者复发1次,26例复发2次,3例复发3次,1例复发4次),33次经病理证实为移行细胞癌。79次检查未发现恶性肿瘤(如果在内镜下看到肿瘤,病理评估显示为异型增生、发育异常或无异常)。这两组人群的NMP22值有显著差异(恶性肿瘤组中位数为每毫升20.81单位,无恶性肿瘤组中位数为每毫升5.72单位,采用曼-惠特尼U检验比较两个中位数,p = 0.00005)。在33例复发患者中,23例(70%)的NMP22值高于参考范围(每毫升10单位)。此外,NMP22识别出了所有6例(100%)在3至6个月后发生浸润性疾病的患者。在72例NMP22低于每毫升10单位的患者中,62例(86%)在随后的膀胱镜检查中未发现恶性肿瘤。
NMP22对随访膀胱镜检查时的肿瘤状态具有高度预测性。这种定量、非侵入性检测方法具有较高的阴性预测值(86%)和检测恶性肿瘤的敏感性(浸润性疾病为100%,总体为70%),可能是细胞学和内镜检查监测内镜肿瘤切除术后疾病状态的有益辅助手段。