Use of Urinary Biomarkers for Bladder Cancer Surveillance: Patient Perspectives

Yossepowitch, Ofer; Herr, Harry W.; Donat, S. Machele

doi:10.1016/j.juro.2006.11.066

Cited by 64 publications

(46 citation statements)

References 15 publications

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“…An important aspect is the patient's opinion and need for a reliable diagnosis. If the sensitivity of a urinary test is <90-95%, most patients prefer cystoscopy with a definitive diagnosis for the follow-up [11,12]. …”

Section: Introductionmentioning

confidence: 99%

Panel of Urinary Diagnostic Markers for Non-Invasive Detection of Primary and Recurrent Urothelial Urinary Bladder Carcinoma

Soukup¹,

Kalousová²,

Čapoun³

et al. 2015

Urol Int

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Objectives: To determine the combination of urinary protein markers for noninvasive detection of primary and recurrent urothelial bladder carcinomas. Methods: Urinary concentrations of 27 biomarkers (NSE, ATT, AFABP, Resistin, Midkine, Clusterin, Uromodulin, ZAG2, HSP27, HSP 60, NCAM1/CD56, Angiogenin, Calreticulin, Chromogranin A, CEACAM1, CXCL1, IL13Ra2, Progranulin, VEGFA, CarbAnhydIX, Annexin-V, TIM4, Galectin1, Cystatin B, Synuclein G, ApoA1 and ApoA2) were assessed by enzyme-linked immunosorbent assay or by electrochemiluminiscence immunoassay. Results: During the primary diagnostics, a group of 70 patients with primary occurrence of bladder cancer and 49 healthy control subjects were compared. For this clinical situation, the most accurate combination proved to be the combination of cytology with markers Midkine and Synuclein G (sensitivity 91.8%, specificity 97.5%). During the monitoring of patients with non-muscle invasive bladder cancer (NMIBC), a group of 44 patients with cancer recurrence was compared with the group of 61 patients with a history of NMIBC without current disease. For this clinical situation, the most accurate combination proved to be the combination of cytology and erythrocytes count in urine sediment with markers Midkine, ZAG2, CEACAM1, and Synuclein G (sensitivity 92.68%, specificity 90.16%). A lower accuracy of the diagnostic panel and the necessity to use more markers in the case of recurrence was connected with a different structure of patients. Conclusions: Multi-marker test can significantly improve the bladder cancer detection both during the primary diagnostics and monitoring of patients with NMIBC. This outcome should result in other, larger studies.

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Section: Introductionmentioning

confidence: 99%

Panel of Urinary Diagnostic Markers for Non-Invasive Detection of Primary and Recurrent Urothelial Urinary Bladder Carcinoma

Soukup¹,

Kalousová²,

Čapoun³

et al. 2015

Urol Int

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“…Voided urine cytology, generally used in conjunction with endoscopic examination, presents limited sensitivity (<50% in our case series), especially in detecting low-grade cancers, and the test accuracy is highly dependent on the experience of the pathologist. The major challenge in bladder cancer detection thus remains the development of noninvasive, accurate and possibly low-cost diagnostic tests to ensure early diagnosis and permit more effective clinical treatments (20,21). As we demonstrated in previous case-control studies, telomerase activity is a promising diagnostic marker because of its accuracy (10,11,22).…”

Section: Discussionmentioning

confidence: 86%

Accuracy of urine telomerase activity to detect bladder cancer in symptomatic patients

et al. 2009

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Telomerase activity assessment in voided urine is an important noninvasive tool for bladder cancer diagnosis. In a previous case-control study we verified that this method can detect tumor cells in urine with high sensitivity and specificity, but few data are still available on its accuracy to detect tumors in patients with symptomatic urinary tract diseases. Following recently published guidelines on bladder cancer, we aimed to define the diagnostic accuracy of urine telomerase levels in symptomatic patients. Telomerase activity, expressed in arbitrary enzymatic units (AEUs), was evaluated in urine collected from 515 patients: 197 with urinary tract symptoms and 318 with a first diagnosis of bladder cancer. Telomerase repeat amplification protocol (TRAP) sensitivity ranged from 93% to 61% and specificity varied from 42% to 88% at the different AEU cutoff values. At the cutoff of 50, the sensitivity was 87% (95% CI 83–91), the specificity was 70% (95% CI 63–75), and the overall accuracy, in terms of true positives and true negatives, was 80%. Sensitivity did not vary in relation to tumor grade or stage at diagnosis, or to patient age. Our results indicate that urine telomerase activity is a good marker for the early diagnosis of bladder tumors in symptomatic patients, a subset which represents an “at-risk” population requiring close surveillance.

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“…Our questionnaire, which was administered post-cystoscopy, also did not query patients regarding acceptable waiting times for a urine test result 14 and postcystoscopy symptoms, which are likely to have influenced patient FN rate choices. 13 Furthermore, our survey did not make a distinction between patients with low-risk versus high-risk disease. Physicians were asked about non-invasive alternatives for any patient with NMIBC (Supplementary Text 2).…”

Section: Cuaj -Original Researchmentioning

confidence: 90%

“…The study determined that male gender and higher pain intensity at cystoscopy were associated with willingness to accept a small level of uncertainty on univariate and multivariate regression analyses. 13 Both studies are limited by their lack of evaluation of physician perspectives. Also, both studies did not investigate acceptable costs for such urinary biomarker(s).…”

Section: Cuaj -Original Researchmentioning

confidence: 99%

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

Sayyid¹,

Sayyid²,

Klaassen³

et al. 2018

CUAJ

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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 favor 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 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.

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Use of Urinary Biomarkers for Bladder Cancer Surveillance: Patient Perspectives

Abstract: From the patient perspective a urinary biomarker would likely require 95% or greater diagnostic accuracy to supplant cystoscopies for routine bladder surveillance. Inadequate sensitivity may be the major impediment to general acceptance of urinary biomarkers in this setting.

Cited by 64 publications

References 15 publications

Panel of Urinary Diagnostic Markers for Non-Invasive Detection of Primary and Recurrent Urothelial Urinary Bladder Carcinoma

Panel of Urinary Diagnostic Markers for Non-Invasive Detection of Primary and Recurrent Urothelial Urinary Bladder Carcinoma

Accuracy of urine telomerase activity to detect bladder cancer in symptomatic patients

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

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