MCM5 urine expression (ADXBLADDER) is a reliable biomarker of high-risk non- muscle-invasive bladder cancer recurrence: A prospective matched case-control study

2020 ◽  
pp. 1-5
Author(s):  
Łukasz Białek ◽  
Katarzyna Czerwińska ◽  
Łukasz Fus ◽  
Wojciech Krajewski ◽  
Anna Sadowska ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
External Validation ◽  
Cancer Recurrence ◽  
Invasive Bladder Cancer ◽  
Control Group ◽  
High Grade ◽  
Urinary Biomarker ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

BACKGROUND: Mini Chromosome Maintenance 5 (MCM5) is considered as a urinary biomarker of bladder cancer. ADXBLADDER is a commercially available test to detect MCM5 antibodies. OBJECTIVE: External validation of ADXBLADDER test as a urinary biomarker of histopathologically confirmed non-muscle invasive bladder cancer (NMIBC) recurrence. METHODS: The study enrolled 119 consecutive patients with a history of NMIBC and 37 healthy volunteers matched as controls. Single, full-void urine samples were collected from patients before cystoscopy ± TUR. To measure MCM5 expression, Arquer Diagnostics ADXBLADDER test was used. The study protocol was registered within the clinical trials database (NCT03796299). RESULTS: Among patients with NMIBC history, recurrence was diagnosed in 83 patients (69.7%). ADXBLADDER demonstrated sensitivity of 73.5% (95% confidence interval (CI) 62.7%–82.6%), specificity of 33.3% (95% CI 18.6% to 51%), overall negative predictive value (NPV) of 35.3% (95% CI 23.3% to 49.5%) and overall positive predictive value of 71.8% (95% CI 66.1% to 76.8%) for detecting recurrence. In a control group, false positive ADXBLADDER results were noticed in 18 patients (48.6%). The sensitivity and NPV were the highest in invasive tumors (100% and 100%, respectively) and in high-grade recurrences (81.8% and 94.1%, respectively). CONCLUSIONS: ADXBLADDER has a moderate sensitivity and poor specificity in detecting NMIBC recurrence. However, it properly diagnoses patients with T1+ stage recurrence or high-grade tumors.

Recurrence in Non-Muscle Invasive Bladder Cancer Patients: External Validation of the EORTC, CUETO and EAU Risk Tables and Towards a Non-Linear Survival Model

2020 ◽  
Vol 6 (3) ◽  
pp. 277-284
Author(s):  
Marit Lucas ◽  
Ilaria Jansen ◽  
Jorg R. Oddens ◽  
Ton G. van Leeuwen ◽  
Henk A. Marquering ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Risk Stratification ◽  
Predictive Value ◽  
Cox Regression ◽  
External Validation ◽  
Cox Proportional Hazards ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Non Linear ◽  
Muscle Invasive

BACKGROUND: EORTC, CUETO and EAU are the most commonly used risk stratification models for recurrence and progression in non-muscle invasive bladder cancer (NMIBC). OBJECTIVE: We assessed the predictive value of the EORTC, CUETO and EAU risk group stratification methods for our population and explore options to improve the predictive value using Cox Proportional Hazards (CPH), Boosted Cox regression and a non-linear Random Survival Forest (RSF) model. MATERIALS: Our retrospective database included of 452 NMIBC patients who underwent a transurethral resection of bladder tumor (TURBT) between 2000 and 2018 in our hospital. The cumulative incidence of recurrence was calculated at one- and five-years for all risk stratification methods. A customized CPH, Boosted Cox and RSF models were trained in order to predict recurrence, and the performances were compared. RESULTS: Risk stratification using the EORTC, CUETO and EAU showed small differences in recurrence probabilities between the risk groups as determined by the risk stratification. The concordance indices (C-index) were low and ranged between 0.51 and 0.57. The predictive accuracies of CPH, Boosted Cox and RSF models were also moderate, with C-indices ranging from 0.61 to 0.64. CONCLUSIONS: Prediction of recurrence in patients with NMIBC based on patient characteristics is difficult. Alternative (non-linear) approaches have the potential to improve the predictive value. Nonetheless, the currently used characteristics are unable to properly stratify between the recurrence risks of patients.

scholarly journals Effectivity of intravescical thermo-chemotherapy prophylaxis for patients with high recurrence and progression risk for non-muscle invasive bladder cancer

2017 ◽  
Vol 89 (2) ◽  
pp. 102 ◽  
Author(s):  
Ali Serdar Gözen ◽  
Paolo Umari ◽  
Walter Scheitlin ◽  
Fuat Ernis Su ◽  
Yigit Akin ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Recurrent Disease ◽  
Bladder Wall ◽  
Invasive Bladder Cancer ◽  
Outpatient Basis ◽  
High Grade ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

Background&Aim: High grade non-muscle invasive bladder cancer (NMIBC) is common in urological practice. Most of these cancers are or become refractory to intravesical immunotherapy and chemotherapy. Here we evaluated the efficacy of combined local bladder hyperthermia and intravesical mitomycin-C (MMC) instillation in patients with high-risk recurrent NMIBC. Materials and methods: Between February 2014 and December 2015, 18 patients with high risk NMIBC were enrolled. Patients were treated in an outpatient basis with 6 weekly induction sessions followed by monthly maintenance sessions with intravesical MMC in local hyperthermia with bladder wall thermo-chemotherapy (BWT) system (PelvixTT system, Elmedical Ltd., Hod Hasharon, Israel). The follow-up regimen included cystoscopy after the induction cycle and thereafter with regular intervals. Time to disease recurrence was defined as time from the first intravesical treatment to endoscopic or histological documentation of a new bladder tumour. Adverse events were recorded according to CTC 4.0 (Common Toxicity Criteria) score system. Results: Mean age was 72 (32-87) years. 10 patients had multifocal disease, 9 had CIS, 6 had recurrent disease and 2 had highly recurrent disease (> 3 recurrences in a 24 months period). 6 patients underwent previous intravesical chemotherapy with MMC. The average number of maintenance sessions per patient was 7.6. After a mean follow-up of 433 days, 15 patients (83.3%) were recurrence-free. 3 patients had tumour recurrence after a mean period of 248 days without progression. Side effects were limited to grade 1 in 2 patients and grade 2 in 1 patient. Conclusions: BWT seems to be feasible and safe in high grade NMIBC. More studies are needed to identify the subgroup of patients who may benefit more from this treatment.

Predictive Value of CD44 in Muscle-Invasive Bladder Cancer and Its Relationship with IL-6 Signaling

2018 ◽  
Vol 25 (12) ◽  
pp. 3518-3526 ◽  
Author(s):  
Chun-Te Wu ◽  
Wei-Yu Lin ◽  
Wen-Cheng Chen ◽  
Miao-Fen Chen
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

scholarly journals Prediction of histological stage based on cystoscopic appearances of newly diagnosed bladder tumours

2016 ◽  
Vol 98 (8) ◽  
pp. 547-551 ◽  
Author(s):  
VA During ◽  
GM Sole ◽  
AK Jha ◽  
JA Anderson ◽  
RT Bryan
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
Bladder Tumour ◽  
Visual Assessment ◽  
Invasive Bladder Cancer ◽  
Newly Diagnosed ◽  
Muscle Invasive Bladder Cancer ◽  
Cross Sectional ◽  
Radiological Staging ◽  
Muscle Invasive

INTRODUCTION In the 75–80% of urothelial bladder cancers (UBC) presenting as non-muscle invasive bladder cancer (NMIBC), transurethral resection of bladder tumour (TURBT) is the key treatment and staging procedure. In the 20–25% of patients with muscle invasive bladder cancer (MIBC), further cross-sectional imaging is required to complete the staging process before considering radical treatment. Given the adverse effects of ionising radiation, clinicians identify patients believed to have MIBC, and so requiring further imaging pre-TURBT, at the tumour histology/stage based on the tumour’s visual characteristics. There is minimal evidence describing the accuracy of such predictions in newly-diagnosed patients. METHODS Over a 6-year period, a database of patients undergoing resection of newly-diagnosed bladder lesions in a single UK centre was prospectively established. Predictions based on histology were simultaneously recorded, and the accuracy of these predictions of histology/stage subsequently assessed. RESULTS One hundred and twenty two (73.1%) patients with histologically confirmed NMIBC had predictions recorded versus 45 (26.9%) patients with MIBC. Visual assessment predictions of MIBC had a sensitivity of 88.9% (95% confidence interval [CI] 76.5%–95.2%) and a specificity of 91.0% (95% CI 84.6%–94.9%), giving a positive predictive value of 78.4% (95% CI 65.4%–87.5%) and a negative predictive value of 95.7% (95% CI 90.3%–98.1%). CONCLUSIONS We find that visual assessment is accurate in predicting the presence of MIBC. This supports the practice of stratifying patients at the time of initial cystoscopy for those requiring further radiological staging pre-TURBT.

scholarly journals Does the Urinary Mast Cell Mediators Predict the Immune Response to BCG in Patients with Primary High-Grade Non-Muscle Invasive Bladder Cancer?

2020 ◽  
Author(s):  
Muhammed Fatih Simsekoglu ◽  
İslim Kaleler ◽  
Bulent Onal ◽  
Cetin Demirdag ◽  
Sinharib Citgez ◽  
...  
Keyword(s):  
Immune Response ◽  
Bladder Cancer ◽  
Mast Cell ◽  
Critical Role ◽  
Invasive Bladder Cancer ◽  
High Grade ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive ◽  
Healthy Participants ◽  
Bcg Instillation

Background: Mast cells play a critical role in tumor-associated immune pathways. We aimed to determine whether the urinary mast cell mediators predict the immune response in patients with non-muscle invasive bladder cancer (NMIBC) treated with Bacillus Calmette-Guérin (BCG) immunotherapy. Methods: Nineteen patients who have received immunotherapy due to NMIBC and 19 healthy participants were enrolled. Urine samples were collected to assay N-methylhistamine, histamine, and tryptase levels immediately before the first BCG instillation, immediately after the third and sixth instillations, and four weeks after the sixth instillation in patients with NMIBC and at a single visit in healthy participants. Cystoscopic examinations were performed on the patient with NMIBC at three-month intervals for two years. The changes in urinary markers due to BCC response, BCG instillation, and the presence of NMIBC were assessed. Results: The average age was 56.1 ± 10.5 years in patients with NMIBC. Fourteen patients had high-grade Ta tumors, and 5 had high-grade T1 tumors. While 12 patients responded, 6 presented with recurrence and 1 with progression. There was no correlation between the levels of mast cell mediators and BCG response. The N-methylhistamine and histamine levels were increased significantly with the onset of immunotherapy, and N-methylhistamine levels were significantly decreased when immunotherapy was terminated. Pre-BCG estimated marginal means of N-methylhistamine were significantly higher in patients with NMIBC than healthy participants. Conclusions: Our study is the first study to identify the changes in mast cell mediators with the onset of immunotherapy and with the presence of bladder cancer. However, these mediators were not found to predict the patients’ response to immunotherapy.

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