scholarly journals Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients

Diagnostics ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. 745
Author(s):  
Caroline A. Sieverink ◽  
Rui P. M. Batista ◽  
Hugo J. M. Prazeres ◽  
João Vinagre ◽  
Cristina Sampaio ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
Disease Recurrence ◽  
Urine Cytology ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
History Of ◽  
Muscle Invasive ◽  
Sensitivity Specificity

The costly and burdensome nature of the current follow-up methods in non-muscle-invasive bladder cancer (NMIBC) drives the development of new methods that may alternate with regular cystoscopy and urine cytology. The Uromonitor-V2® is a new urine-based assay in the detection of hotspot mutations in three genes (TERT, FGFR3, and KRAS) for evaluation of disease recurrence. The aim of this study was to investigate the Uromonitor-V2®’s performance in detecting NMIBC recurrence and compare it with urine cytology. From February 2018 to September 2019 patients were enrolled. All subjects underwent a standard-of-care (SOC) cystoscopy, either as part of their follow-up for NMIBC or for a nonmalignant urological pathology. Urine cytology was performed in NMIBC patients. Out of the 105 patients enrolled, 97 were eligible for the study. Twenty patients presented nonmalignant lesions, 29 had a history of NMIBC with disease recurrence, and 49 had a history of NMIBC without recurrence. In NMIBC, the Uromonitor-V2® displayed a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 93.1%, 85.4%, 79.4%, and 95.3%, respectively. Urine cytology was available for 52 patients, and the sensitivity, specificity, PPV, and NPV were 26.3%, 90.9%, 62.5%, and 68.2%, respectively. With its high NPV of 95.3%, the Uromonitor-V2® revealed promising properties for the follow-up of patients with NMIBC.

scholarly journals Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by non-muscle invasive bladder cancer

2018 ◽  
Vol 72 (2) ◽  
pp. 140-144 ◽  
Author(s):  
Carolina D´Elia ◽  
Alexander Pycha ◽  
Decio M Folchini ◽  
Christine Mian ◽  
Esther Hanspeter ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
Superficial Bladder Cancer ◽  
Invasive Bladder Cancer ◽  
Low Grade ◽  
Urinary Marker ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive ◽  
Sensitivity Specificity

AimsCystoscopy and urine cytology represent the gold standard for monitoring superficial bladder cancer (BC). Xpert BC Monitor is a new urinary marker based on the evaluation of five target mRNAs overexpressed in patients with bladder cancer. The aim of our study was to evaluate the diagnostic accuracy of Xpert BC Monitor in follow-up of patients with non-muscle invasive bladder cancer (NMIBC).Methods230 patients were included in this prospective study. Xpert BC Monitor cut-off was set to 0.5. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cytology, Xpert BC Monitor and their combination were calculated and compared with cystoscopy/histology.Results52/230 patients showed a NMIBC recurrence, 45 low grade (LG) and 7 high grade (HG). Overall sensitivity was 11.5% for cytology, 46.2% for Xpert BC Monitor and 48.1% for the two tests combined. Sensitivity of cytology increased from 4.4% in LG to 57.1% in HG tumours whereas for the Xpert BC Monitor it was 40% in LG and 85.7% in HG tumours. Combined cytology and Xpert BC Monitor yielded an overall sensitivity of 42% for LG and 85.7% for HG. Overall specificity was 97.2% for cytology, 77% for Xpert BC Monitor and 75.8% for the two tests.ConclusionsSensitivity for the Xpert BC Monitor Test was significantly higher than for cytology. The test performed very well in terms of specificity but could not reach the value of cytology, while PPV and NPV performed approximately the same for both tests.

Oncotherad immunotherapy elicits promising responses in Bacillus Calmette-Guérin-unresponsive non–muscle invasive bladder cancer: Results from phase I/ II study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17048-e17048
Author(s):  
João Carlos Cardoso Alonso ◽  
Ianny Brum Reis ◽  
Juliana Mattoso Gonçalves ◽  
Bianca Ribeiro de Souza Sasaki ◽  
Adriano Angelo Cintra ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Adverse Events ◽  
Phase I ◽  
Tumor Recurrence ◽  
Disease Recurrence ◽  
Invasive Bladder Cancer ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

e17048 Background: Standard treatment for high-grade non-muscle-invasive bladder cancer (HGNMIBC) is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guérin (BCG) immunotherapy. Up to 40% of patients with HGNMIBC will fail intravesical BCG therapy. A promising therapeutic perspective is represented by OncoTherad immunotherapy. OncoTherad is a nanostructured inorganic phosphate complex associated to glycosidic protein developed by University of Campinas/Brazil that exhibits antitumor properties. The aims of this study were to evaluate the efficacy and safety of OncoTherad immunotherapy for BCG-refractory or relapsed HGNMIBC. Methods: We conducted a prospective, single-center (Municipal Hospital of Paulinia, São Paulo, Brazil), single-arm phase I/ II study of OncoTherad immunotherapy in 29 (18 male, 11 female) patients with BCG-unresponsive HGNMIBC (≥ 1 previous course of BCG intravesical therapy). The schedule was initiated with weekly intravesical (120 mg/mL) and intramuscular (25 mg/mL) OncoTherad treatment for 6 weeks, followed by one every other week application for 3 months and, one monthly application until the end of the treatment (24 months). Follow-up was performed with systematic mapping biopsies of the bladder, cystoscopy and ultrasound. The primary endpoint was pathological complete response (pCR) and recurrence-free survival (RFS). The recurrence was defined as histology proven tumor recurrence (any grade) and monitored at 3-month intervals. Secondary endpoints were time to disease recurrence and safety response. Results: The median age of the 29 patients was 64 years (range 34-94). At baseline pTis, pTaG2-3, pT1G2-3 occurred in 10%, 59% and 31% of patients respectively. OncoTherad treatment showed pCR rates (95% CI) of 100% at 3, 6 and 9 months, 89,6% (26/29) at 12 months and, 89,6% (26/29) at 24 months. A 24-months RFS rate in all patients was 79,3%. Also, the median time to disease recurrence for patients was 459 days (15,3 months; 95% CI) at 24-months follow-up. 95% of adverse events were Grade 1 or 2. The most commonly reported treatment-related adverse events were dysuria (51,7%), cystitis (34,5%), pruritus (44,8%), rash (27,6%), arthralgia (27,6%) and fatigue (27,6%). Conclusions: In conclusion, OncoTherad seems a safe and effective treatment option for BCG-unresponsive HGNMIBC patients and may provide benefit for preventing tumor recurrence. Clinical trial information: RBR-6swqd2.

scholarly journals Accuracy of Inchworm Sign on Diffusion-Weighted MRI in Differentiating Muscle-Invasive Bladder Cancer

2021 ◽  
pp. 1-10
Author(s):  
Huseyin Ozgur Kazan ◽  
Meftun Culpan ◽  
Nesrin Gunduz ◽  
Ferhat Keser ◽  
Ayberk Iplikci ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Predictive Values ◽  
Diffusion Weighted ◽  
Primary Bladder ◽  
Muscle Invasive ◽  
Sensitivity Specificity ◽  
Primary Bladder Cancer

BACKGROUND: Inchworm sign is a finding on diffusion-weighted magnetic resonance imaging (DWI-MRI) and is used to better stratify T-staging in muscle invasive (MIBC) and non-muscle-invasive bladder cancer (NMIBC). An uninterrupted low submucosal signal on DWI, defined as inchworm sign (IS), indicates NMIBC. OBJECTIVE: We aimed to define the diagnostic accuracy of IS in primary bladder cancer, as well as find agreement between the urologists and the radiologist. METHODS: Between December 2018 and December 2020, we retrospectively analyzed 95 primary bladder cancer patients who had undergone multiparametric-MRI before transurethral resection. Patients with former bladder cancer history, tumors smaller than 10 mm, and MRI without proper protocol, as well as patients who did not attend follow-up, were excluded. In total, 71 patients’ images were evaluated by a genitourinary specialist radiologist and two urologists. Sensitivity, specificity, positive and negative predictive values of IS and VI-RADS in differentiating MIBC and NMIBC, and interreader agreement between the radiologist and urologists were analyzed. RESULTS: During follow-up, 38 patients (53.5%) were IS-positive, while 33 patients (46.5%) were negative. Among the 33 patients with negative IS, 14 patients (42.4%) had MIBC. Meanwhile, two out of the 38 IS-positive patients (5.3%) had MIBC (p = 0.00). Sensitivity, specificity, and positive and negative predictive values of IS in predicting MIBC were 87.5%, 63.6%, 41.2%and 94.6%, respectively. The interobserver agreement between the urologists and radiologist was almost perfect ( K  = 0.802 and K  = 0.745) CONCLUSION: The absence of IS on DWI is useful in differentiating MIBC from NMIBC. It is a simple finding that can be interpreted by urologists.

The significance of protocol biopsy after intravesical BCG treatment in patients with non-muscle–invasive bladder cancer.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 356-356
Author(s):  
Satoru Maruyama ◽  
Nobuo Shinohara ◽  
Norihiro Murahashi ◽  
Hidetaka Suzuki ◽  
Ryuji Matsumoto ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Survival Rate ◽  
High Risk ◽  
Adverse Events ◽  
Predictive Value ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Protocol Biopsy ◽  
Muscle Invasive

356 Background: Currently, there are few well-validated data of the optimal schedule of follow-up after BCG intravesical instillation. The objective of the study were to elucidate the ability of conventional exams (cystoscopy, urine cytology) to diagnose presence of carcinoma and the significance of protocol biopsy after BCG intravesical treatment in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). Methods: The study included patients treated with BCG intravesical treatment. From January 2002 to October 2012, we retrospectively reviewed a total of 72 patients (61 men and 11 women). The median age was 72 years (range 47-84). The pathological stages were Tis in 4 patients (6%), Ta in 29 (40%) and T1 in 39 (54%) (T1 with CIS in 30 [42%]). Tumors were multifocal in 56 (78%) and second TUR had been performed in 53 (74%) patients. We investigated the prognosis and accuracy of tumor existence by conventional exams referring with the protocol biopsy. A protocol biopsy was performed within 5 to 9 months after the final TUR. CTCAE v4.0 was used to grade adverse events. Results: Of 72 patients, we performed protocol biopsy in 62 patients and 9 (15%) had cancer. The conventional methods had a sensitivity of 78%, specificity of 81%, positive predictive value of 41% and negative predictive value of 96% in diagnosing cancer. Although three (5%) had grade2 adverse events, there were no grade 3 or greater adverse events. Of 53 patients with no cancer in protocol biopsy, 8 (8%) patients experienced a recurrence but 51patients (96%) were alive with no evidence of disease. Of 9 patients pointed out cancer in protocol biopsy, 7patients (78%) had no evidence of disease recurrence at last follow-up. The 5-year recurrence-free survival rate and overall survival rate were 77% and 95%, respectively. Conclusions: To the best of our knowledge, this is the first report of the ability of conventional exams for follow-up after BCG treatment. Our findings revealed that conventional exams were limited for meticulous follow-up, so that the protocol biopsy will be recommended to obtain the better survival in high-risk NMIBC patients.

scholarly journals Diagnostic predictive value of the Bladder EpiCheck test in the follow‐up of patients with non–muscle‐invasive bladder cancer

2019 ◽  
Vol 127 (7) ◽  
pp. 465-469 ◽  
Author(s):  
Emanuela Trenti ◽  
Carolina D'Elia ◽  
Christine Mian ◽  
Christine Schwienbacher ◽  
Esther Hanspeter ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

scholarly journals Comparing CxBladder to Urine Cytology as Adjunct to Cystoscopy in Surveillance of Non-muscle Invasive Bladder Cancer—A Pilot Study

2021 ◽  
Vol 8 ◽  
Author(s):  
C. A. Chai ◽  
W. S. Yeoh ◽  
R. Rajandram ◽  
K. P. Aung ◽  
T. A. Ong ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Predictive Value ◽  
Urine Cytology ◽  
Urine Samples ◽  
Invasive Bladder Cancer ◽  
Low Grade ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive ◽  
Inflammatory Changes

Purpose: Guidelines advocate cystoscopy surveillance (CS) for non-muscle invasive bladder cancer (NMIBC) post-resection. However, cystoscopy is operator dependent and may miss upper tract lesions or carcinoma in-situ (CIS). Urine cytology is a common adjunct but lacks sensitivity and specificity in detecting recurrence. A new mRNA biomarker (CxBladder) was compared with urine cytology as an adjunct to cystoscopy in detecting a positive cystoscopy findings during surveillance cystoscopy in our center.Materials and Methods: Consented patients older than 18, undergoing CS for NMIBC, provide paired urine samples for cytology and CxBladder test. Patients with positive cystoscopy findings would undergo re-Trans Urethral Resection of Bladder Tumor (TURBT).Results: Thirty-five patients were enrolled from April to June 2019. Seven contaminated urine samples were excluded. The remaining cohort of 23 (82%) and 5 (18%) females had a mean age of 66.69 (36–89). Eight (29%) patients with positive cystoscopy finding underwent TURBT. All 8 patients also had positive CxBladder result. This shows that CxBladder has a sensitivity and negative predictive value (NPV) of 100%, specificity of 75% and positive predictive value (PPV) of 62% in predicting a positive cystoscopy finding. TURBT Histo-pathological findings showed Low-grade Ta NMIBC in one patient (4%), and 7 (25%) patients had inflammatory changes. Urine cytology was only positive in one patient with a positive cystoscopy finding. This led to a sensitivity of merely 13% and NPV of 74%, while specificity and PPV was 100% in predicting a positive cystoscopy finding.Conclusion: CxBladder had high NPV and sensitivity which accurately predicted suspicious cystoscopy findings leading to further investigation. It has great potential for use as adjunct to cystoscopy for surveillance of NMIBC.

scholarly journals Assessment of Xpert Bladder Cancer Monitor test performance for the detection of recurrence during non-muscle invasive bladder cancer follow-up

2021 ◽  
Author(s):  
G. Cancel-Tassin ◽  
M. Roupret ◽  
U. Pinar ◽  
C. Gaffory ◽  
F. Vanie ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Test Performance ◽  
Daily Practice ◽  
Superior Performance ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Predictive Values ◽  
Muscle Invasive ◽  
Sensitivity Specificity

Abstract Purpose To assess the performance of the Xpert Bladder Cancer (BC) Monitor during the follow-up of patients with non-muscle invasive bladder cancer (NMIBC). Methods Patients with previously diagnosed NMIBC and followed up in clinical practice settings in two French urology departments between September 2017 and July 2019 were consecutively enrolled in this prospective observational study. Patients with a positive cystoscopy or computed tomography urogram underwent subsequent transurethral resection of the bladder, and/or biopsy, and the specimens were pathologically assessed. Cytology and Xpert BC Monitor tests were performed on urine samples. Xpert BC Monitor performance was assessed versus cystoscopy for disease-negative patients or versus histology for disease-positive patients, and was compared to that of cytology. Results Overall, 500 patients with a median age of 70.0 years were included. NMIBC recurrence was diagnosed in 44 cases (8.8%). Overall sensitivity, specificity, and negative predictive values (NPVs) were 72.7% (32/44), 73.7% (330/448) and 96.5% (330/342) for the Xpert BC Monitor, and 7.7% (2/26), 97.8% (310/317) and 92.8% (310/334) for cytology, respectively. The Xpert BC Monitor detected 92.3% (12/13) of the high-grade tumours and ruled out their presence in 99.7% (330/331) of cases. Analysis of the areas under the receiver operating characteristic curves demonstrated the superior performance of the Xpert BC Monitor over that of cytology. Conclusion Xpert BC Monitor performance was superior to that of cytology in the follow-up of NMIBC. The exclusion of aggressive tumours with a very high NPV (99.7%) supports the use of this urinary test in daily practice.

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