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在非肌层浸润性膀胱癌患者随访中用尿液生物标志物取代监测性膀胱镜检查:患者及泌尿外科肿瘤学家的观点

Replacing surveillance cystoscopy with urinary biomarkers in followup of patients with non-muscle-invasive bladder cancer: Patients' and urologic oncologists' perspectives.

作者信息

Sayyid Rashid K, Sayyid Abdallah K, Klaassen Zachary, Hersey Karen, Goldberg Hanan, Perlis Nathan, Ahmad Ardalanejaz, Leao Ricardo, Chandrasekar Thenappan, Fadaak Kamel, Madi Rabii, Terris Martha K, Finelli Antonio, Hamilton Robert J, Kulkarni Girish S, Zlotta Alexandre R, Fleshner Neil E

机构信息

Department of Surgery, Division of Urology, University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada.

Augusta University Medical Centre, Augusta, GA, United States.

出版信息

Can Urol Assoc J. 2018 May;12(5):E210-E218. doi: 10.5489/cuaj.4922. Epub 2018 Feb 6.

Abstract

INTRODUCTION

Urinary biomarkers are being developed to detect bladder cancer recurrence/progression in patients with non-muscle-invasive bladder cancer (NMIBC). We conducted a questionnaire-based study to determine what diagnostic accuracy and cost would such test(s) need for both patients and urologic oncologists to comfortably forgo surveillance cystoscopy in favour of these tests.

METHODS

Surveys were administered to NMIBC patients at followup cystoscopy visit and to physician members of the Society of Urologic Oncology. Participants were questioned about acceptable false-negative (FN) rates and costs for such alternatives, in addition to demographics that could influence chosen error rates and costs.

RESULTS

A total of 137 patient and 51 urologic oncologist responses were obtained. Seventy-seven percent of patients were not comfortable with urinary biomarker(s) alternatives to repeat cystoscopy, with a further 14% willing to accept such alternatives only if the FN rate were 0.5% or lower. Seventy-five percent of urologic oncologists were comfortable with an alternative urinary biomarker test(s), with 37% and 33% willing to accept FN rates of 5% and 1%, respectively. Forty-seven percent of patients were not willing to pay out-of-pocket for such tests, while 61% of urologic oncologists felt that a price range of $100-500 would be reasonable.

CONCLUSIONS

This is the first survey evaluating patient and urologic oncologist perspectives on acceptable error rates and costs for urinary biomarker alternatives to surveillance cystoscopy for patients with NMIBC. Despite potential responder bias, this study suggests that urinary biomarker(s) will require sensitivity equivalent to that of cystoscopy in order to completely replace it in surveillance of patients with NMIBC.

摘要

引言

正在研发尿液生物标志物以检测非肌层浸润性膀胱癌(NMIBC)患者的膀胱癌复发/进展情况。我们开展了一项基于问卷调查的研究,以确定此类检测对于患者和泌尿外科肿瘤学家而言,需要具备怎样的诊断准确性和成本,才能让他们放心地放弃监测性膀胱镜检查而选择这些检测。

方法

在随访膀胱镜检查时对NMIBC患者以及泌尿外科肿瘤学会的医生会员进行调查。除了询问可能影响所选错误率和成本的人口统计学信息外,还向参与者询问了对此类替代检测可接受的假阴性(FN)率和成本。

结果

共获得137名患者和51名泌尿外科肿瘤学家的回复。77%的患者对用尿液生物标志物替代重复膀胱镜检查不满意,另有14%的患者仅在FN率为0.5%或更低时才愿意接受此类替代方法。75%的泌尿外科肿瘤学家对尿液生物标志物替代检测感到满意,分别有37%和33%的人愿意接受5%和1%的FN率。47%的患者不愿意自掏腰包支付此类检测费用,而61%的泌尿外科肿瘤学家认为100 - 500美元的价格范围是合理的。

结论

这是第一项评估患者和泌尿外科肿瘤学家对于NMIBC患者监测性膀胱镜检查的尿液生物标志物替代检测可接受错误率和成本观点的调查。尽管存在潜在的应答偏倚,但本研究表明,尿液生物标志物需要具备与膀胱镜检查相当的敏感性,才能在NMIBC患者的监测中完全取代它。

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