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      Treatment and disease management patterns for bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer in North America, Europe and Asia: A real-world data analysis

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          Abstract

          Background

          This study examined real-world treatment and management of bacillus Calmette-Guérin (BCG)-unresponsive patients across 3 continents, including patients unable or unwilling to undergo cystectomy.

          Materials and methods

          Physicians actively involved in managing patients with nonmuscle invasive bladder cancer completed online case report forms for their 5 consecutive patients from the broad BCG-unresponsive population and a further 5 consecutive BCG-unresponsive patients who did not undergo cystectomy (in Japan, physicians provided a total of 5 patients across both cohorts).

          Results

          Most patients had received 1 (37%) or 2 (24%) maintenance courses of BCG. Five or more maintenance BCG courses were received by patients in Japan (59%) and China (31%), while in Germany 76% of patients received only 1 course. Most patients became BCG-unresponsive during their first (44%) or second (22%) treatment course; in Germany, 77% became BCG-unresponsive during their first treatment course. Most countries did not provide another course of BCG after a patient first became unresponsive, whereas unresponsive patients in Japan and China were most likely to be retreated with BCG. “Untreated - on watch and wait” was the main treatment/management approach received post-BCG treatment for 42% or more of patients in most countries except China (39%) and the United States (36%). “Following treatment guidelines” was consistently the top reason for post-BCG treatment selection across all treatment options.

          Conclusions

          This study confirmed the global unmet need for patients with nonmuscle invasive bladder cancer, and found that many patients experienced periods of no treatment after not responding to BCG therapy.

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          Most cited references18

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          European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update

          This overview presents the updated European Association of Urology (EAU) guidelines for non-muscle-invasive bladder cancer (NMIBC), TaT1, and carcinoma in situ (CIS).
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            Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

            This selection from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer focuses on the clinical presentation and workup of suspected bladder cancer, treatment of non–muscle-invasive urothelial bladder cancer, and treatment of metastatic urothelial bladder cancer because important updates have recently been made to these sections. Some important updates include recommendations for optimal treatment of non–muscle-invasive bladder cancer in the event of a bacillus Calmette-Guérin (BCG) shortage and details about biomarker testing for advanced or metastatic disease. The systemic therapy recommendations for second-line or subsequent therapies have also been revised. Treatment and management of muscle-invasive, nonmetastatic disease is covered in the complete version of the NCCN Guidelines for Bladder Cancer available at NCCN.org . Additional topics covered in the complete version include treatment of nonurothelial histologies and recommendations for nonbladder urinary tract cancers such as upper tract urothelial carcinoma, urothelial carcinoma of the prostate, and primary carcinoma of the urethra.
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              Guideline of guidelines: non-muscle-invasive bladder cancer

              Non-muscle invasive bladder cancer (NMIBC) represents the vast majority of bladder cancer diagnoses, however this definition represents a spectrum of disease with a variable clinical course notable for significant risk of recurrence and potential for progression. Management involves risk-adapted strategies of cystoscopic surveillance and intravesical therapy with a goal of bladder preservation when safe to do so. Multiple organizational guidelines exist to help practitioners manage this complicated disease process, however adherence to management principles amongt practicing urologists is reportedly low. We review four major organizational guidelines on NMIBC: American Urological Association (AUA)/Society of Urologic Oncology (SUO), European Association of Urology (EAU), National Comprehensive Cancer Network (NCCN), and National Institute for Health and Care Excellence (NICE).
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                Author and article information

                Journal
                Curr Urol
                Curr Urol
                CURR-UROL
                Current Urology
                Lippincott Williams & Wilkins
                1661-7649
                1661-7657
                September 2022
                2 August 2022
                : 16
                : 3
                : 147-153
                Affiliations
                [a ]WW Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, USA
                [b ]The University of North Carolina, Chapel Hill, NC, USA
                [c ]Observational Research Department, Adelphi Real World, Bollington, UK
                Author notes
                [*] []Corresponding Author: Edward I. Broughton, 3401 Prnceton Pike, Lawrence Township, NJ 08648, USA. E-mail address: edwardbro@ 123456gmail.com (E. Broughton).
                Article
                CURR-UROL_220056 00006
                10.1097/CU9.0000000000000072
                9527932
                6cf591d5-b030-492b-ab1e-dc02dc7a8b1c
                Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

                History
                : 17 June 2021
                : 8 November 2021
                Categories
                Special Topic: Advances in bladder cancer therapy: Original Article
                Custom metadata
                TRUE

                bacillus calmette-guérin,bladder cancer,cystectomy,treatment failure,urinary tract

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