Dataset Information

Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial.

ABSTRACT:

Background

The surveillance of non-muscle invasive bladder cancer (NMIBC) requires frequent cystoscopies, which are costly and uncomfortable for patients. Uromonitor is a validated non-invasive urinary test for detecting NMIBC recurrence. However, data on its clinical benefit in an NMIBC surveillance program is limited.

Objective

To assess the diagnostic accuracy of Uromonitor in NMIBC surveillance and its potential to limit the number of cystoscopies.

Design, setting, and participants

The study included 202 patients with previous low-grade (LG) NMIBC tumors. Newly diagnosed patients were scheduled for flexible cystoscopy and Uromonitor test at 4, 12, and 24 months from the time of diagnosis. Patients with tumors diagnosed before entering the study underwent cystoscopy and Uromonitor test at the start of the study and 12 and 24 months from inclusion in the study.

Outcome measurements and statistical analysis

Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV).

Results and limitations

Between February 2020 and October 2022, 202 patients were enrolled in the study. Of these patients, 171 met the eligibility criteria to perform the analysis, with a median age of 69 years, IQR (62-74), and 380 flexible cystoscopies with simultaneous Uromonitor tests. Overall, 39/171 (22.8%) patients had recurrences. Uromonitor showed a sensitivity of 89.7%, specificity of 96.2%, PPV of 72.9%, and NPV of 98.8%. In 28 cases, flexible cystoscopy was falsely positive, leading to surgery, where Uromonitor showed negative results. There were 13 cases of possible false positives for Uromonitor where flexible cystoscopy was negative.

Conclusions

Uromonitor displays high diagnostic accuracy in detecting NMIBC recurrence with the potential for reducing the number of flexible cystoscopies in the follow-up of low- and intermediate-risk NMIBC.

Patient summary

We followed up on newly and previously diagnosed patients with LG NMIBC. We concluded that Uromonitor could potentially reduce the number of cystoscopies in NMIBC surveillance programs.

SUBMITTER: Azawi N

PROVIDER: S-EPMC10137147 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial.

Azawi Nessn N Vásquez Juan Luis JL Dreyer Thomas T Guldhammer Cathrine Silberg CS Saber Al-Juboori Rami Muthanna RM Nielsen Anna Munk AM Jensen Jørgen Bjerggaard JB

Cancers 20230417 8

<h4>Background</h4>The surveillance of non-muscle invasive bladder cancer (NMIBC) requires frequent cystoscopies, which are costly and uncomfortable for patients. Uromonitor is a validated non-invasive urinary test for detecting NMIBC recurrence. However, data on its clinical benefit in an NMIBC surveillance program is limited.<h4>Objective</h4>To assess the diagnostic accuracy of Uromonitor in NMIBC surveillance and its potential to limit the number of cystoscopies.<h4>Design, setting, and part ...[more]

PMID: 37190269

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Project description:BackgroundSurveillance 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.ObjectivesTo 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.MethodsA 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%.ResultsOf 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. Both groups had 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.ConclusionsRandomization 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.

Project description:ImportanceLow-risk non-muscle-invasive bladder cancer (NMIBC) is associated with extremely low rates of progression and cancer-specific mortality; however, patients with low-risk NMIBC may often receive non-guideline-recommended and potentially costly surveillance testing and treatment.ObjectiveTo describe current surveillance and treatment practices, cancer outcomes, and costs of care for low-grade papillary stage Ta (low-grade Ta) NMIBC and identify factors associated with increased cost of care.Design, setting, and participantsThis population-based cohort study identified 13 054 older adults (aged 66-90 years) diagnosed with low-grade Ta tumors in the Surveillance, Epidemiology and End Results-linked Medicare database from January 1, 2004, through December 31, 2013. Medicare claims data through December 31, 2014, were also reviewed. Data were analyzed from April 1 to October 6, 2021.ExposuresSurveillance testing and treatment among patients with low-grade Ta NMIBC.Main outcomes and measuresThe primary outcome was patterns in population-level surveillance and treatment practice over time among patients with low-grade Ta NMIBC. Secondary outcomes were recurrence (defined as receipt of subsequent transurethral resection of bladder tumor >3 months after index diagnosis of NMIBC and initial transurethral resection of bladder tumor), progression (defined as receipt of definitive treatment for bladder cancer), and costs of care.ResultsAmong 13 054 patients who met inclusion criteria, 9596 (73.5%) were male and 3458 (26.5%) were female, with a median age of 76 years (IQR, 71-81 years). A total of 403 patients (3.1%) were Black, 120 (0.9%) were Hispanic, 12 123 (92.9%) were White, and 408 (3.1%) were of other races and/or ethnicities. Rates of surveillance cystoscopy increased over the study period (from 79.3% in 2004 to 81.5% in 2013; P = .007), with patients receiving a median of 3.0 cystoscopies per year (IQR, 2.0-4.0 per year). Rates of upper tract imaging (particularly computed tomography or magnetic resonance imaging) also increased over the study period (from 30.4% in 2004 to 47.0% in 2013; P < .001), with most patients receiving a median of 2.0 imaging tests per year (IQR, 1.0-2.0 per year). The use of urine cytologic testing or other urine biomarker assessment also increased (from 44.8% in 2004 to 54.9% in 2013; P < .001). Rates of adherence to current guidelines were similar over time (eg, a median of 4398 patients [55.2%] received ≤2 cystoscopies per year in 2004-2008 vs a median of 2736 patients [53.8%] in 2009-2013; P = .11), suggesting overuse of all surveillance testing modalities. With regard to treatment, 2250 patients (17.2%) received intravesical bacillus Calmette-Guérin, and 792 patients (6.1%) received intravesical chemotherapy (excluding receipt of a single perioperative dose). Among all patients with low-grade Ta NMIBC, 217 (1.7%) experienced disease recurrence and 52 (0.4%) experienced disease progression. The total annual median costs of low-grade Ta surveillance testing and treatment increased by 60% (from $34 792 in 2004 to $53 986 in 2013), with higher 1-year median expenditures noted among those with disease recurrence ($76 669) vs no disease recurrence ($53 909) at the end of the study period.Conclusions and relevanceIn this cohort study, despite low rates of disease recurrence and progression, rates of surveillance testing increased during the study period. The annual cost of care also increased over time, particularly among patients with recurrent disease. Efforts to improve adherence to current practice guidelines, with the focus on limiting overuse of surveillance testing and treatment, may mitigate associated increasing costs of care.

Dataset Information

Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial.

Background

Objective

Design, setting, and participants

Outcome measurements and statistical analysis

Results and limitations

Conclusions

Patient summary

Publications

Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial.

Similar Datasets

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