uCyt+/ImmunoCyt™ in the detection of recurrent urothelial carcinoma

Mian, Christine; Maier, Klaus; Comploj, Evi; Lodde, Michele; Berner, Lucas; Lusuardi, Lukas; Palermo, Salvatore; Vittadello, Fabio; Pycha, Armin

doi:10.1002/cncr.21712

Cited by 70 publications

(23 citation statements)

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“…In addition, due to the low risk of tumor progression, marker-guided surveillance could significantly reduce the number of control cystoscopies without placing patients at significant risk. However, to date only one prospective trial using a marker-guided surveillance protocol has been performed [116]. Information from this study, however, is still preliminary and does not yet permit recommendation of this procedure for clinical routine use.…”

Section: Key Questionsmentioning

confidence: 99%

“…There was one prospective trial on marker-guided follow-up providing information that may be classified as LoE grade 1b [116,117] according to the Oxford classification for diagnostic procedures [25]. The very same trial was classified as a phase III trial concerning the IBCN classification on marker development [8], while all remaining studies were considered phase II.…”

Section: Cell-based Assaysmentioning

confidence: 99%

“…After removal of reviews, meta-analyses, and redundant trials, 20 studies assessable for criteria concerning assay performance and comprising more than 5,000 individuals were identified, forming the basis for this assessment of assay performance [13,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114]. …”

Section: Cell-based Assaysmentioning

confidence: 99%

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Molecular Markers for Bladder Cancer Screening, Early Diagnosis, and Surveillance: The WHO/ICUD Consensus

et al. 2014

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Due to the lack of disease-specific symptoms, diagnosis and follow-up of bladder cancer has remained a challenge to the urologic community. Cystoscopy, commonly accepted as a gold standard for the detection of bladder cancer, is invasive and relatively expensive, while urine cytology is of limited value specifically in low-grade disease. Over the last decades, numerous molecular assays for the diagnosis of urothelial cancer have been developed and investigated with regard to their clinical use. However, although all of these assays have been shown to have superior sensitivity as compared to urine cytology, none of them has been included in clinical guidelines. The key reason for this situation is that none of the assays has been included into clinical decision-making so far. We reviewed the current status and performance of modern molecular urine tests following systematic analysis of the value and limitations of commercially available assays. Despite considerable advances in recent years, the authors feel that at this stage the added value of molecular markers for the diagnosis of urothelial tumors has not yet been identified. Current data suggest that some of these markers may have the potential to play a role in screening and surveillance of bladder cancer. Well-designed protocols and prospective, controlled trials will be needed to provide the basis to determine whether integration of molecular markers into clinical decision-making will be of value in the future.

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Section: Key Questionsmentioning

confidence: 99%

Section: Cell-based Assaysmentioning

confidence: 99%

Section: Cell-based Assaysmentioning

confidence: 99%

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Molecular Markers for Bladder Cancer Screening, Early Diagnosis, and Surveillance: The WHO/ICUD Consensus

et al. 2014

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“…One candidate biomarker is immunocytology, which uses three fluorescently labelled monoclonal antibodies directed against UCB-associated antigens (carcinoembryonic antigen and two bladder tumor–associated mucins). Previous multicentre studies have demonstrated that immunocytology has a higher sensitivity than urinary cytology in the surveillance of UCB patients, especially for low-grade tumors [5,8], leading to US Food and Drug Administration approval for its use in conjunction with cytology for surveillance. Several small single-institution studies have suggested that immunocytology may also perform well in the detection of UCB in patients with painless hematuria [9,10].…”

Section: Introductionmentioning

confidence: 99%

Immunocytology Is a Strong Predictor of Bladder Cancer Presence in Patients With Painless Hematuria: A Multicentre Study

et al. 2012

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Background Although the performance of immunocytology has been established in the surveillance of patients with urothelial carcinoma of the bladder (UCB), its value in the initial detection of UCB in patients with painless hematuria remains unclear. Objective To determine whether immunocytology improves our ability to predict the likelihood of UCB in patients with painless hematuria. Further, to test the clinical benefit of immunocytology in this setting using decision curve analysis. Design, setting, and participants The subjects were 1182 consecutive patients without a history of UCB presenting with painless hematuria and were enrolled at three centres. Intervention All patients underwent upper-tract imaging, cystourethroscopy, voided urine cytology, and immunocytology analysis. Bladder tumors were biopsied and histologically confirmed as UCB. Measurements Multivariable regression models were developed. Area under the curve was measured and compared using the DeLong test. A nomogram was constructed from the full multivariable model. Decision curve analysis was performed to evaluate the clinical benefit associated with use of the multivariable models including immunocytology. Results and limitations Immunocytology had the largest contribution to a multivariable model for the prediction of UCB (odds ratio: 18.3; p < 0.0001), which achieved a 90.8% predictive accuracy. Decision curve analysis revealed that models incorporating immunocytology achieved the highest net benefit at all threshold probabilities. Conclusions Immunocytology is a strong predictor of the presence of UCB in patients who present with painless hematuria. Incorporation of immunocytology into predictive models improves diagnostic accuracy by a statistically and clinically significant margin. The use of immunocytology in the diagnostic workup of patients with hematuria appears promising and should be further evaluated.

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“…The overall sensitivity of this combination ranges from 40% to 92% and specificity from 62% to 84%. [30–32] Studies by Mian et al , 942 patients,[33] Pfister et al , - a French multicenter study of 694 patients[34] and Messing et al , a multicenter study in USA 341 patients[35] confirm the findings of improved sensitivity and specificity with this combination when used in the follow-up of the patients with bladder cancer. This combination of ImmunoCyt and cytology has been studied to replace the cystocopy in the surveillance of Ta, low-grade lesions by Lodde et al .…”

Section: Discussionmentioning

confidence: 86%

Rationale for an early detection program for bladder cancer

Khochikar

2011

Indian J Urol

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Introduction:A total of 356,557 new cases were diagnosed annually worldwide in 2009, it was estimated that 52,810 new patients were to be diagnosed with bladder cancer and there were 10,180 projected deaths from the disease in the USA. Despite being the fourth commonest cancer in men, we do not have an early detection/screening program for bladder cancer. The review was aimed at looking at the evidence for the rationale for an early detection program for bladder cancer.Materials and Methods:A detailed search on bladder cancer epidemiology, diagnosis, pathology, tumor markers, treatment outcomes, screening, morbidity and mortality of bladder cancer was carried out on Pubmed central/Medline. Original articles, review articles, monograms, book chapters on bladder cancer, text books on urological oncology, oncology and urology were reviewed. The latest information for new articles before publication was last accessed in June 2010.Discussion and Conclusions:Bladder cancer is the fourth commonest cancer in men, the annual death rate from this disease is significant and every year there is an increase in its incidence globally. The prognosis of bladder cancer is stage and grade dependent; the lower the stage (T2 or less) the better is the survival. Delay in the diagnosis and treatment does alter the overall outcome. Therefore, there is a clear need for early detection of bladder cancer and screening program. Although we do not have an ideal marker for bladder cancer, it is time we maximize the potential of markers such as UroVysion, NMP22 along with cytology to start such a program. May be as a first step the early detection and screening program could be started in high-risk population. It is not worth waiting till we find the best marker as it would be unfair to our patients. The fear of unnecessary tests and treatment in bladder cancer after its detection in screening program is without any substance. The cost-effectiveness of such a program is certainly comparable to that is used for colon or breast and for prostate as well.

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uCyt+/ImmunoCyt™ in the detection of recurrent urothelial carcinoma

Cited by 70 publications

References 100 publications

Molecular Markers for Bladder Cancer Screening, Early Diagnosis, and Surveillance: The WHO/ICUD Consensus

Molecular Markers for Bladder Cancer Screening, Early Diagnosis, and Surveillance: The WHO/ICUD Consensus

Immunocytology Is a Strong Predictor of Bladder Cancer Presence in Patients With Painless Hematuria: A Multicentre Study

Rationale for an early detection program for bladder cancer

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