Shariat Shahrokh F, Marberger Michael J, Lotan Yair, Sanchez-Carbayo Marta, Zippe Craig, Lüdecke Gerson, Boman Hans, Sawczuk Ihor, Friedrich Martin G, Casella Roberto, Mian Christine, Eissa Sanaa, Akaza Hideyuki, Serretta Vincenzo, Huland Hartwig, Hedelin Hans, Raina Rupesh, Miyanaga Naoto, Sagalowsky Arthur I, Roehrborn Claus G, Karakiewicz Pierre I
Department of Urology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.
J Urol. 2006 Sep;176(3):919-26; discussion 926. doi: 10.1016/j.juro.2006.04.017.
We assessed variability in the diagnostic performance of NMP22 for detecting recurrence and progression in patients with Ta, T1, and/or CIS transitional cell carcinoma of the bladder in a large international cohort.
NMP22 voided urine levels were measured in 2,871 patients who underwent office cystoscopy for monitoring previous stage Ta, T1 and/or CIS transitional cell carcinoma at 12 participating institutions.
Patient characteristics varied considerably among institutions. Overall 1,045 patients (36.4%) had recurrent transitional cell carcinoma (range across institutions 13.6% to 54.3%). Median NMP22 was 5.5 U/ml (range across institutions 2.5 to 18.8). Of the patients 33.5% had grade III tumors (range across institutions 20.6% to 54.0%) and 22.4% had muscle invasive tumors (range across institutions 3.2% to 38.2%). Area under the ROC curve for bladder TCC detection was 0.735 (95% CI 0.715 to 0.755, range across institutions 0.676 to 0.889). The manufacturer recommended cutoff of 10 U/ml detected 57% of cases with a 19% false-positive rate. AUC for grade III and stage T2 or greater disease was 0.806 (95% CI 0.780 to 831) and 0.864 (95% CI 0.839 to 0.890), respectively. For each NMP22 cutoff NMP22 had higher sensitivity for detecting grade III and stage T2 or greater bladder transitional cell carcinoma than for detecting any cancer. No optimal cutoffs for detecting any or aggressive bladder transitional cell carcinoma could be derived based on NMP22 values.
There is a substantial degree of heterogeneity in the diagnostic performance of NMP22 applied to populations from different institutions. There is no clearly defined NMP22 cutoff but there is a continuum of risk for recurrence and progression.
我们在一个大型国际队列中评估了NMP22在检测膀胱Ta、T1和/或CIS移行细胞癌患者复发和进展方面诊断性能的变异性。
在12个参与机构中，对2871例因监测既往Ta、T1和/或CIS期移行细胞癌而接受门诊膀胱镜检查的患者测量了NMP22的晨尿水平。
各机构间患者特征差异很大。总体上，1045例患者（36.4%）有复发性移行细胞癌（各机构范围为13.6%至54.3%）。NMP22的中位数为5.5 U/ml（各机构范围为2.5至18.8）。患者中33.5%患有III级肿瘤（各机构范围为20.6%至54.0%），22.4%患有肌层浸润性肿瘤（各机构范围为3.2%至38.2%）。膀胱TCC检测的ROC曲线下面积为0.735（95%CI 0.715至0.755，各机构范围为0.676至0.889）。制造商推荐的10 U/ml的临界值可检测出57%的病例，假阳性率为19%。III级和T2期或更晚期疾病的AUC分别为0.806（95%CI 0.780至0.831）和0.864（95%CI 0.839至0.890）。对于每个NMP22临界值，NMP22检测III级和T2期或更晚期膀胱移行细胞癌的敏感性高于检测任何癌症。基于NMP22值无法得出检测任何或侵袭性膀胱移行细胞癌的最佳临界值。
应用于不同机构人群时，NMP22的诊断性能存在很大程度的异质性。没有明确界定的NMP22临界值，但复发和进展风险是连续的。
