Svatek Robert S, Sagalowsky Arthur I, Lotan Yair
Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX 75390-9110, USA.
Urol Oncol. 2006 Jul-Aug;24(4):338-43. doi: 10.1016/j.urolonc.2005.11.025.
The Food and Drug Administration recently approved the use of bladder markers such as BladderChek (NMP22; Matritech, Inc., Newton, MA) and UroVysion (Abbott Laboratories, Abbott Park, IL) for use in screening for bladder cancer. The purpose of this analysis was to assess the cost associated with implementing a widespread screening program using a noninvasive bladder tumor marker.
Data for the accuracy of NMP22 in detecting bladder cancer was gathered from a comprehensive literature review. A decision tree analysis was constructed to evaluate the total cost of screening a low and high-risk population for bladder cancer using NMP22. Sensitivity analyses were conducted to evaluate the effect of relaxing the various assumptions in the model.
Application of the model to all men, regardless of the degree of risk, rendered a cost per cancer detected of $783,913, $269,028, and $139,305 for ages 50-59, 60-69, and 70-79 years, respectively. Screening only patients at high-risk for bladder cancer (annual incidence 6%) would yield a cost per cancer detected of $3,310. Incidence of cancer and marker specificity had the highest influence on cost per cancer detected.
Application of NMP22 to the entire population would render an extremely high cost per cancer detected. However, application to an appropriate high-risk target population could achieve cost per cancer detected comparable to currently used screening programs for prostate, colon, and breast cancer. Further studies are needed to assess the accuracy of bladder tumor markers in detecting bladder cancer in a completely asymptomatic cohort.
美国食品药品监督管理局最近批准使用膀胱标志物,如膀胱检测试剂(NMP22;Matritech公司,马萨诸塞州牛顿市)和尿视明(雅培实验室,伊利诺伊州雅培公园)用于膀胱癌筛查。本分析的目的是评估使用非侵入性膀胱肿瘤标志物实施广泛筛查计划的相关成本。
通过全面的文献综述收集NMP22检测膀胱癌准确性的数据。构建决策树分析以评估使用NMP22对低风险和高风险人群进行膀胱癌筛查的总成本。进行敏感性分析以评估放宽模型中各种假设的影响。
该模型应用于所有男性,无论风险程度如何,50 - 59岁、60 - 69岁和70 - 79岁年龄组每检测出一例癌症的成本分别为783,913美元、269,028美元和139,305美元。仅对膀胱癌高风险患者(年发病率6%)进行筛查,每检测出一例癌症的成本为3,310美元。癌症发病率和标志物特异性对每检测出一例癌症的成本影响最大。
将NMP22应用于整个人群会导致每检测出一例癌症的成本极高。然而,应用于适当的高风险目标人群可使每检测出一例癌症的成本与目前用于前列腺癌、结肠癌和乳腺癌的筛查计划相当。需要进一步研究以评估膀胱肿瘤标志物在完全无症状队列中检测膀胱癌的准确性。