scholarly journals Alternating Cystoscopy with Bladder EpiCheck ® in the Surveillance of Low-Grade Intermediate-Risk NMIBC: A Cost Comparison Model

2021 ◽  
pp. 1-9
Author(s):  
Yair Lotan ◽  
Georgios Gakis ◽  
Matteo Manfredi ◽  
Juan Morote ◽  
Hugh Mostafid ◽  
...  

BACKGROUND: Bladder cancer surveillance is invasive, intensive and costly. Patients with low grade intermediate risk non-muscle invasive bladder cancer (NMIBC) are at high risk of recurrence. OBJECTIVE: The objective of this model is to compare the cost of a strategy to alternate surveillance with cystoscopy and a urine marker, Bladder EpiCheck, to standard surveillance. METHODS: A decision tree model was built using TreeAge Pro Healthcare to compare standard surveillance (Standard) with a modified surveillance incorporating Bladder EpiCheck. The model was based on 2 years of surveillance. Outcomes were obtained from literature. Costs were obtained from US and 9 European countries. Sensitivity analyses were performed. RESULTS: The efficacy of the model was equivalent in terms of recurrence for each arm with median recurrence rate of 22%. When setting marker price at 200 local currency, the marker arm was less expensive in the USA, Netherlands, Switzerland, Belgium, Italy, Austria and UK by 154€ to 329€ per patient, for a 2-year period. Cost was higher in France, Spain, and Germany by 33–103€. Cost parity was achieved with marker price between 148€ and $421. Marker cost and specificity have the greatest impact on the overall model cost. CONCLUSIONS: A strategy alternating the urine marker Bladder EpiCheck with cystoscopy in the surveillance of patients with low grade intermediate risk bladder cancer is cost equivalent in the US and European countries when the marker is priced 148€ –$421, as a result of the marker’s high specificity (86%). Prospective studies will be necessary to validate these findings.

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
D Goodman ◽  
R Taggart ◽  
J Salmond ◽  
E H Day

Abstract Aim This study addresses surveillance cystoscopy in patients diagnosed with bladder and upper tract cancer. Managed Clinical Network (MCN) guidelines have clear recommendations for the timetable of follow-up cystoscopy, and we conducted this audit to study regional compliance. Method Using a multisite pathology database of bladder cancer cases from 2016, we collected and analysed data on 100 non-muscle invasive bladder cancers. We took the first 10 cases from each month to ensure cross-regional representation. Each case was stratified according to MCN guidelines. Electronic medical records were examined to assess upper tract follow up. We allowed for +/- 1 month each side of the target timeframe. Results We had 64 male and 36 female subjects. In our risk categories, we had 31 low risk, 37 intermediate risk and 32 high risk bladder cancers. 67 were new cases, 33 were recurrent tumours. 10 (43.4%) of low-risk and 19 (79.2%) of intermediate-risk patients underwent surveillance cystoscopy earlier than the recommended 12-month timeframe. 18 (78.3%) of low-risk patients continued to have further surveillance cystoscopies after a 12-month disease-free period. Conclusions 43.4% of low-risk bladder cancer patients are receiving surveillance cystoscopy earlier than recommended. 78.3% of these patients are then undergoing unnecessary procedures following a 12-month disease-free period against regional guidelines and recommendations. This places an increased burden on clinic/theatre time and contributes to patient anxiety surrounding cancer follow-up. Evidence-based medicine guidelines have shown that less is more when it comes to low-grade bladder cancer surveillance. We now need to assess why we are deviating from our own guidelines.


2020 ◽  
Vol 10 ◽  
Author(s):  
Lei Peng ◽  
Jinze Li ◽  
Chunyang Meng ◽  
Jinming Li ◽  
Dandan Tang ◽  
...  

BackgroundThis study aimed to evaluate the diagnostic value of telomerase activity (TA) for bladder cancer (BC) by meta-analysis.MethodsWe conducted a systematic search of studies published on PubMed, Embase, and Web of Science up to June 1, 2019. We used Stata 15 and Review Manager 5.3 for calculations and statistical analysis.ResultsTo evaluate the diagnostic value of TA for BC, we performed a meta-analysis on 22 studies, with a total of 2,867 individuals, including sensitivity, specificity, positive and negative likelihood ratio (PLR, NLR), diagnostic odds ratio (DOR), and 95% confidence intervals (CIs). The pooled parameters were calculated from all studies, and we found a sensitivity of 0.79 (95% CI: 0.72–0.84), a specificity of 0.91 (95% CI: 0.87–0.94), a PLR of 8.91 (95% CI: 5.91–13.43), an NLR of 0.24 (95% CI: 0.15–0.37), a DOR of 37.90 (95% CI: 23.32–61.59), and an AUC of 0.92 (95% CI: 0.90–0.94). We also conducted a subgroup analysis based on the different stages and grades of BC. Results from the subgroup analysis showed that there was no significant difference in TA in either high and low stages of BC, but that low-grade tumors had a lower TA than high-grade tumours.ConclusionsTA can be used as a potential biomarker for the diagnosis of bladder cancer with its high specificity. Rigorous and high-quality prospective studies are required to verify our conclusion.


2021 ◽  
Vol 8 ◽  
Author(s):  
Sukumar S. Sugeeta ◽  
Anand Sharma ◽  
Kenrick Ng ◽  
Arvind Nayak ◽  
Nikhil Vasdev

Aim: This is a narrative review with an aim to summarise and describe urinary biomarkers in the surveillance of non-muscle-invasive bladder cancer (NMIBC). It provides a summary of FDA-approved protein biomarkers along with emerging ones which utilise genetic, epigenetic and exosomal markers. We discuss the current limitations of the available assays.Background: Current guidelines advice a combination of cystoscopy, imaging,and urine cytology in diagnosis and surveillance. Although cytology has a high specificity, it is limited by low sensitivity particularly in low grade tumours. There are six FDA-approved urinary assays for diagnosis and surveillance of bladder cancer. They have shown to improve sensitivity and specificity to be used alongside cytology and cystoscopy but have a lower specificity in comparison to cytology and false positives often occur in benign conditions. Recent developments in laboratory techniques has allowed for use of markers which are RNA-, DNA-based as well as extracellular vesicles in the past decade.Methods: Using the PubMed/Medline search engines as well as Google Scholar, we performed an online search using the terms “bladder cancer,” “non-muscle invasive bladder cancer,” and “urine biomarkers” with filter for articles in English published up to May 2021. Systematic reviews and original data of clinical trials or observational studies which contributed to the development of the biomarkers were collated.Results: Biomarkers identified were divided into FDA-approved molecular biomarkers, protein biomarkers and gene-related biomarker with a table summarising the findings of each marker with the most relevant studies. The studies conducted were mainly retrospective. Due to the early stages of development, only a few prospective studies have been done for more recently developed biomarkers and limited meta-analyses are available.Therefore a detailed evaluation of these markers are still required to decide on their clinical use.Conclusion: Advancements of analytical methods in BC has driven the research towards non-invasive liquid-based biomarkers in adjunct to urine cytology. Further large prospective studies are required to determine its feasibility in a clinical setting as they are not effective when used in isolation as they have their limitation. With the ongoing pandemic, other than reduction in costs and increased accuracy, the need for biomarkers to cope with delay in cystoscopies in diagnosis and surveillance is crucial. Thus clinical trials with direct comparison is required to improve patient care.


2012 ◽  
Vol 187 (4S) ◽  
Author(s):  
Ian Udell ◽  
Raj Kurpad ◽  
Angela Smith ◽  
Michael Woods ◽  
Eric Wallen ◽  
...  

2021 ◽  
pp. 1-11
Author(s):  
Ryan M. Reyes ◽  
Emily Rios ◽  
Shane Barney ◽  
Cory M. Hugen ◽  
Joel E. Michalek ◽  
...  

BACKGROUND: Surveillance regimens for non-muscle invasive bladder cancer (NMIBC) are disparate and controlled trials could inform guidelines. The feasibility of randomizing patients to variable frequency surveillance is unknown. OBJECTIVES: To determine patient willingness to randomization to high frequency (HF) versus low frequency (LF) surveillance regimen for NMIBC and compare patient comfort and healthcare costs across regimens. METHODS: A non-blinded, two-arm, randomized-controlled study of patients with low or low-intermediate risk NMIBC was conducted at two institutions where patients were offered randomization to HF vs. LF surveillance following initial tumor resection. The HF group underwent cystoscopy every three months for 2 years, then every 6 months for 2 years, then annually. The LF group underwent cystoscopy at 9 months following the 3-month cystoscopy, then annually. Assuming 75%of patients approached would agree to enrollment, a sample size of n = 35 patients per arm provided a one-sided 95%exact Clopper-Pearson confidence lower-limit of 60%. RESULTS: Of 70 patients approached, 45 (64.3%) agreed to participate and 25 (35.7%) declined enrollment due to preference for HF. Twelve biopsies were performed, including 4 (19%) of 21 patients in the HF group and 8 (33.3%) of 24 patients in the LF group. Disease recurrence (low grade Ta) was observed in 3 (14.3%) and 5 (20.8%) patients in the HF and LF groups, respectively. No patients experienced high grade recurrence or progression. Groups reported similar patient-reported procedure-related discomfort and quality of life measures over time. Patient out-of-pocket cost and healthcare systems costs were $383.80 more per patient annually in the HF group. CONCLUSIONS: Randomization to variable frequency surveillance is challenging as over a third of patients declined participation. However, these data provide important preliminary insights into the potential effects of surveillance frequency on oncologic and economic outcomes in patients with low and low-intermediate risk bladder cancer.


2012 ◽  
Vol 215 (3) ◽  
pp. S145
Author(s):  
Ian Udell ◽  
Raj Kurpad ◽  
Angela B. Smith ◽  
Michael E. Woods ◽  
Eric Wallen ◽  
...  

2013 ◽  
Vol 189 (4S) ◽  
Author(s):  
Hiroaki Kobayashi ◽  
Eiji Kikuchi ◽  
Takahiro Maeda ◽  
Nobuyuki Tanaka ◽  
Kazuhiro Matsumoto ◽  
...  

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