Clinical Utility of Cxbladder Monitor for Patients with a History of Urothelial Carcinoma: A Physician-Patient Real-World Clinical Data Analysis

Tony Lough, Qingyang Luo, Paul O'Sullivan, Christophe Chemaslé, Michael Stotzer, James Suttie, David Darling, Tony Lough, Qingyang Luo, Paul O'Sullivan, Christophe Chemaslé, Michael Stotzer, James Suttie, David Darling

Abstract

Introduction: International guidelines advocate regular surveillance of patients following urothelial carcinoma (UC). A validated molecular diagnostic non-invasive urine test, Cxbladder Monitor, correctly identifies patients with a UC history who have low-probability of recurrence. The present study assesses the clinical utility of Cxbladder Monitor in reducing the number and frequency of urologic procedures ordered without missing detection of recurrent UC.

Methods: Data from 828 physician-patient assessments were generated from 18 participant physicians who each evaluated the same real-world clinical case data for 30 patients undergoing surveillance for recurrent UC. Each physician ordered tests and procedures and their timing, following review of the patient's demographic data, pre-existing conditions, risk factors and clinical history before and after disclosure of Cxbladder Monitor results. Changes in the number, type and timing of procedures ordered were assessed.

Results: The addition of Cxbladder Monitor significantly reduced the overall number of tests ordered by 38.7%, including flexible cystoscopy by 43%, for patients whose Cxbladder Monitor result was low-probability. When the result was elevated-probability, the number of procedures ordered, including cystoscopy, was increased consistent with the increased risk of recurrent UC. Importantly, based on the tests ordered by each physician for each of the patients, all cases of recurrent UC would have been detected.

Conclusion: The increase in clinical utility of Cxbladder Monitor for the management of patients undergoing surveillance for recurrent UC was shown to be driven by the reduction in procedures ordered for low-probability patients and for the more invasive procedures ordered for elevated-probability patients. In this study, the total number of procedures ordered, including the number of cystoscopies, was reduced especially in patients with low-probability of UC. The invasive procedures were ordered in a more targeted fashion for elevated-probability patients, without compromising the detection of recurrent UC. CLINICALTRIALS.

Gov identifier: NCT02700659.

Funding: Pacific Edge Limited.

Keywords: Biomarker; Clinical parameters; Clinical utility; Cystoscopy; Diagnostic; Molecular diagnostic; Physician–patient interaction; Surveillance for recurrence; Urothelial carcinoma.

Figures

Fig. 1
Fig. 1
Heat maps representing the total number of diagnostic tests at baseline (a) and change (− 23.9%) relative to baseline after Cxbladder Monitor results (b). Green and red side-line bars represent patients with Cxbladder Monitor defined low-probability (− 38.7%) and elevated-probability (+ 11.5%) results, respectively. The horizontal black line emphasises this delineation across the heat map. Columns represent participant physicians and rows represent patients, for the 540 interactions following at the first clinical visit. Each cell represents a physician–patient interaction. In a, each cell includes the total count with darker shades consistent with higher count and in b, reds represent interactions with added procedures and greens represent interactions with removed procedures
Fig. 2
Fig. 2
Heat maps representing the total number of cystoscopy (flexible and rigid) procedures at baseline (a) and change (− 24.6%) relative to baseline after Cxbladder Monitor results (b). Green and red side-line bars represent patients with Cxbladder Monitor defined low-probability (− 40.4%) and elevated-probability (+ 8.4%) results, respectively. The horizontal black line emphasises this delineation across the heat map. Columns represent participant physicians and rows represent patients, for the 540 interactions following at the first clinical visit. Each cell represents a physician–patient interaction. In a, each cell includes the total count with darker shades consistent with higher count and in b, reds represent interactions with added procedures and greens represent interactions with removed procedures

References

    1. Global Burden of Disease Study 2013 Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study. Lancet Lond Engl. 2015;386:743–800. doi: 10.1016/S0140-6736(15)60692-4.
    1. American Cancer Society. What are the key statistics about bladder cancer? [Internet]. . Updated January 5, 2017. Accessed 14 Sept 2017.
    1. Barocas DA, Globe DR, Colayco DC, Onyenwenyi A, Bruno AS, Bramley TJ, et al. Surveillance and treatment of non-muscle-invasive bladder cancer in the USA. Adv Urol. 2012;2012:421709. doi: 10.1155/2012/421709.
    1. Ahmad I, Patel R, Liu Y, Singh LB, Taketo MM, Wu X-R, et al. Ras mutation cooperates with β-catenin activation to drive bladder tumourigenesis. Cell Death Dis. 2011;2:e124. doi: 10.1038/cddis.2011.7.
    1. Chamie K, Litwin MS, Bassett JC, Daskivich TJ, Lai J, Hanley JM, et al. Recurrence of high-risk bladder cancer: a population-based analysis. Cancer. 2013;119:3219–3227. doi: 10.1002/cncr.28147.
    1. Sylvester RJ, van der Meijden APM, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006;49:466–477. doi: 10.1016/j.eururo.2005.12.031.
    1. Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196:1021–1029. doi: 10.1016/j.juro.2016.06.049.
    1. Clark PE, Agarwal N, Biagioli MC, Eisenberger MA, Greenberg RE, Herr HW, et al. Bladder cancer. J Natl Compr Cancer Netw JNCCN. 2013;11:446–475. doi: 10.6004/jnccn.2013.0059.
    1. Babjuk M, Böhle A, Burger M, Capoun O, Cohen D, Compéat EM, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2016. Eur Urol. 2017;71:447–461. doi: 10.1016/j.eururo.2016.05.041.
    1. Yeung C, Dinh T, Lee J. The health economics of bladder cancer: an updated review of the published literature. PharmacoEconomics. 2014;32:1093–1104. doi: 10.1007/s40273-014-0194-2.
    1. Grosse SD, Khoury MJ. What is the clinical utility of genetic testing? Genet Med. 2006;8:448–450. doi: 10.1097/01.gim.0000227935.26763.c6.
    1. Parkinson DR, McCormack RT, Keating SM, Gutman SI, Hamilton SR, Mansfield EA, et al. Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer. Clin Cancer Res. 2014;20:1428–1444. doi: 10.1158/1078-0432.CCR-13-2961.
    1. Peabody JW, Shimkhada R, Tong KB, Zubiller MB. New thinking on clinical utility: hard lessons for molecular diagnostics. Am J Manag Care. 2014;20:750–756.
    1. Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M, et al. Economic aspects of bladder cancer: what are the benefits and costs? World J Urol. 2009;27:295–300. doi: 10.1007/s00345-009-0395-z.
    1. Lotan Y, O’Sullivan P, Raman JD, Shariat SF, Kavalieris L, Frampton C, et al. Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma. Urol. Oncol. 2017;35:531.e15–531.e22. doi: 10.1016/j.urolonc.2017.03.008.
    1. Mowatt G, Zhu S, Kilonzo M, Boachie C, Fraser C, Griffiths TRL, et al. Systematic review of the clinical effectiveness and cost-effectiveness of photodynamic diagnosis and urine biomarkers (FISH, ImmunoCyt, NMP22) and cytology for the detection and follow-up of bladder cancer. Health Technol Assess Winch Engl. 2010;14:1–331.
    1. Lotan Y, Roehrborn CG. Sensitivity and specificity of commonly available bladder tumor markers versus cytology: results of a comprehensive literature review and meta-analyses. Urology. 2003;61:109–118. doi: 10.1016/S0090-4295(02)02136-2.
    1. de Bekker-Grob EW, van der Aa MNM, Zwarthoff EC, Eijkemans MJC, van Rhijn BW, van der Kwast TH, et al. Non-muscle-invasive bladder cancer surveillance for which cystoscopy is partly replaced by microsatellite analysis of urine: a cost-effective alternative? BJU Int. 2009;104:41–47. doi: 10.1111/j.1464-410X.2008.08323.x.
    1. Koo K, Zubkoff L, Sirovich BE, Goodney PP, Robertson DJ, Seigne JD, et al. The burden of cystoscopic bladder cancer surveillance: anxiety, discomfort, and patient preferences for decision making. Urology. 2017;108:122–128. doi: 10.1016/j.urology.2017.07.016.
    1. Kavalieris L, O’Sullivan P, Frampton C, Guilford P, Darling D, Jacobson E, et al. Performance characteristics of a multigene urine biomarker test for monitoring for recurrent urothelial carcinoma in a multicenter study. J Urol. 2017;197:1419–1426. doi: 10.1016/j.juro.2016.12.010.
    1. Darling D, Luxmanan C, O’Sullivan P, Lough T, Suttie J. Clinical utility of Cxbladder for the diagnosis of urothelial carcinoma. Adv Ther. 2017;34:1087–1096. doi: 10.1007/s12325-017-0518-7.
    1. Lough T, Luo Q, Luxmanan C, Anderson A, Suttie J, O’Sullivan P, Darling D. Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis. BMC Urol. 2018;18(1):18. doi: 10.1186/s12894-018-0327-6.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere