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A review of avelumab in locally advanced and metastatic bladder cancer.

ABSTRACT: Urothelial carcinoma remains a devastating disease with a poor prognosis. Though immune therapy with Bacillus Calmette-Guérin (BCG) has been used for localized bladder cancer for years, only immune-checkpoint blockade with antiprogrammed cell-death 1 (anti-PD-1) and antiprogrammed cell-death ligand 1 (anti-PD-L1) inhibitors have demonstrated improvement in survival of patients with metastatic disease. Anti-PD-L1 antibody, avelumab, was recently given United States Food and Drug Administration (FDA) accelerated approval for the treatment of recurrent/metastatic urothelial carcinoma after failure of first-line chemotherapy, marking the fifth immune checkpoint inhibitor to be given FDA approval for the treatment of metastatic urothelial cancer. The following manuscript will review avelumab, its pharmacology, and the clinical experience that has led to its approval, as well as future plans for clinical development of avelumab for the treatment or urothelial cancer.

SUBMITTER: Rao A

PROVIDER: S-EPMC6354303 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature

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A review of avelumab in locally advanced and metastatic bladder cancer.

Rao Arpit A Patel Manish R MR

Therapeutic advances in urology 20190130

Urothelial carcinoma remains a devastating disease with a poor prognosis. Though immune therapy with <i>Bacillus Calmette-Guérin</i> (BCG) has been used for localized bladder cancer for years, only immune-checkpoint blockade with antiprogrammed cell-death 1 (anti-PD-1) and antiprogrammed cell-death ligand 1 (anti-PD-L1) inhibitors have demonstrated improvement in survival of patients with metastatic disease. Anti-PD-L1 antibody, avelumab, was recently given United States Food and Drug Administra ...[more]

PMID: 30728859

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Project description:ObjectiveMetastatic bladder cancer is an aggressive disease that can often be difficult to diagnose and stage with conventional cross-sectional imaging. The primary objective of this study was to determine the clinical value of fluorine-18 2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/MRI for surveillance and restaging of patients with muscle-invasive, locally advanced, and metastatic bladder cancer compared to conventional imaging methods.Materials and methodsThis retrospective study enrolled patients with muscle-invasive, locally advanced and metastatic bladder cancer in a single institute evaluated with 18F-FDG PET/MRI. All patients also underwent conventional imaging with CT. Additional imaging may also have included 18F-FDG PET/CT (18F-FDG PET), or sodium fluoride (NaF) PET/CT in some patients. Images were reviewed by a diagnostic radiologist/nuclear medicine physician. Number of lesions and sites of disease were captured and compared between 18F-FDG PET/MRI and conventional imaging. Lesions were confirmed by sequential imaging or lesion biopsy. All patients were followed for survival.ResultsFifteen patients (4 for surveillance; 11 for restaging) underwent 34 18F-FDG PET/MRI scans. Each patient received a corresponding conventional CT around the time of the 18F-FDG PET/MRI (median 6 days). The 15 patients (11 male; 4 female) had a median age of 61.5 years (range 37-73) and histologies of urothelial carcinoma (n = 13) and small-cell carcinoma of the bladder (n = 2) diagnosed as stage 4 (n = 13), stage 3 (n = 1), or stage 2 (n = 1). 18F-FDG PET/MRI detected 82 metastatic malignant lesions involving lymph nodes (n = 22), liver (n = 10), lung (n = 34), soft tissue (n = 12), adrenal glands (n = 1), prostate (n = 1), and bone (n = 2) with a resultant advantage of 36% for lesion visibility in comparison with CT. Serial imaging or biopsy confirmed these lesions as malignant.Conclusion18F-FDG PET/MRI can detect metastatic lesions which cannot be identified on conventional CT, and this can allow for better treatment planning and improved disease monitoring during therapy.

Project description:BackgroundThe standard of care for locally advanced bladder cancer (LABC) is neoadjuvant chemotherapy followed by cystectomy. However, the role of adjuvant therapy for locally advanced bladder cancer is unclear.ObjectiveThe purpose of this study was to evaluate the outcomes of adjuvant radiation therapy (RT) for patients with LABC, and to determine which risk factors best predict for patients who may best benefit from adjuvant RT.MethodsThe National Cancer Data Base (NCDB) was queried (2004- 2013) for patients with newly-diagnosed pT3-4N0-3M0 urothelial carcinoma of the bladder that received neoadjuvant chemotherapy and cystectomy. Patients were divided into two groups based on the adjuvant therapy they received: RT or observation. Statistics included multivariable logistic regression to determine factors predictive of receiving adjuvant RT, Kaplan-Meier analysis to evaluate overall survival (OS), and Cox proportional hazards modeling to determine variables associated with OS.ResultsAltogether, 1,646 patients met inclusion criteria; 59 (3.6%) patients received adjuvant RT, while 1,587 (96.4%) were observed. Patients treated with adjuvant RT were more likely to be female, have positive surgical margins, and receive treatment at a non-academic facility. There was no difference in median overall survival (OS) between patients treated with RT when compared to patients observed (17.7 months vs. 23.5 months; p = 0.085). However, an improvement in median OS with the use of adjuvant RT was observed among patients with positive surgical margins (20.3 months vs. 13.1 months; p = 0.032). On multivariate analysis, advancing age, pT4 stage, positive N stage, positive margins, and lower socioeconomic status were associated with worse OS.ConclusionsIn the largest study to date evaluating efficacy of adjuvant radiotherapy in patients with locally advanced bladder cancer, use of RT was not associated with OS in all patients, while RT was associated with improvemed OS among patients with positive surgical margins. Prospective studies are recommended to confirm these findings.

Project description:Objective:To estimate the budget impact of introducing avelumab as a second-line (2L) treatment option for patients with locally advanced or metastatic urothelial cancer (mUC) from the perspective of a US third-party payer (commercial and Medicare). Methods:A budget impact model (BIM) with a three-year time horizon was developed for avelumab. Efficacy and safety data were sourced from published literature and US package inserts. The analysis was conducted in collaboration with a specialist oncologist who validated clinical assumptions. Costs were based on the number of eligible patients, time-to-treatment failure, overall survival, adverse events (AEs), and projected market shares of various treatments. Results:In a hypothetical commercial health plan of 30,000,000 members, 884 patients were estimated to be eligible for 2L treatment over a three-year time period. Without avelumab, the total cost for treating patients with mUC was estimated to be US$70,268,035. The introduction of avelumab increased total costs by $73,438 (0.10% increase). In a hypothetical Medicare health plan of 30,000,000 beneficiaries, a total of 4,705 patients were estimated to be eligible for 2L treatment. Without avelumab, the total cost for treating patients with mUC was estimated to be $292,923,098 from a Medicare perspective; however, with avelumab, there was an increase of $719,324 (0.25% increase) in total costs. Results of the sensitivity analyses demonstrated a cost-neutral impact across all tested scenarios from both perspectives. Conclusion:The BIM estimated that avelumab would have a cost-neutral impact within a US commercial and a Medicare health plan. Overall, avelumab can be an affordable and valuable treatment option for patients with locally advanced or mUC in the 2L setting. These findings demonstrate a consistently favorable budget impact in both populations. Further studies should be conducted to more comprehensively assess the clinical and economic implications of adding avelumab to the treatment armamentarium of 2L mUC.

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A review of avelumab in locally advanced and metastatic bladder cancer.

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A review of avelumab in locally advanced and metastatic bladder cancer.

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