Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non–Muscle-Invasive Bladder Cancer on Tumor Recurrence

Messing, Edward M.; Tangen, Catherine M.; Lerner, Seth P.; Sahasrabudhe, Deepak M.; Koppie, Theresa M.; Wood, David P.; Mack, Philip C.; Svatek, Robert S.; Evans, Christopher P.; Hafez, Khaled S.; Culkin, Daniel J.; Brand, Timothy C.; Karsh, Lawrence I.; Holzbeierlein, Jeffrey M.; Wilson, Shandra; Wu, Guan; Plets, Melissa; Vogelzang, Nicholas J.; Thompson, Ian M.

doi:10.1001/jama.2018.4657

Cited by 181 publications

(148 citation statements)

References 40 publications

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“…Single‐dose postoperative chemotherapy has been shown to reduce the risk of recurrence , however, 67% of urologists in a national US sample never administer immediate postoperative therapy owing to lack of chemotherapy availability, expense, tumour depth/perforation uncertainty, or fear of toxic side effects . Recent results published by the SWOG group showed that single‐dose postoperative intravesical gemcitabine reduces recurrence by 20% in histologically confirmed low‐grade NMIBC at a median follow‐up of 4 years in a randomized prospective sample . This provides a more readily available, cheaper alternative to other chemotherapy agents for the immediate postoperative setting.…”

Section: Resultsmentioning

confidence: 99%

Update on the guideline of guidelines: non‐muscle‐invasive bladder cancer

2019

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Non‐muscle‐invasive bladder cancer (NMIBC) is the most common form of bladder cancer, with frequent recurrences and risk of progression. Risk‐stratified treatment and surveillance protocols are often used to guide management. In 2017, BJUI reviewed guidelines on NMIBC from four major organizations: the American Urological Association/Society of Urological Oncology, the European Association of Urology, the National Comprehensive Cancer Network, and the National Institute for Health and Care Excellence. The present update will review major changes in the guidelines and broadly summarize new recommendations for treatment of NMIBC in an era of bacillus Calmette‐Guérin shortage and immense novel therapy development.

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Section: Resultsmentioning

confidence: 99%

Update on the guideline of guidelines: non‐muscle‐invasive bladder cancer

2019

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“…A randomized, double-blind, phase III trial of 406 patients with suspected low-grade non-muscle-invasive bladder cancer based on cystoscopic appearance showed that immediate post-TURBT instillation of gemcitabine reduced the rate of recurrence compared with saline instillation (placebo). 9 In the intention to treat analysis, 35% of patients treated with gemcitabine and 47% of those who received placebo had disease recurrence within 4 years (HR, 0.66; 95% CI, 0.48-0.90; P,.001). 9 Intravesical therapy for a previous non-muscle-invasive bladder cancer was allowed in the study if received at least 6 months before enrollment.…”

Section: Intravesical Therapymentioning

confidence: 99%

“…Existing data support this approach largely for low-volume, lowgrade disease. [9][10][11] Although selected mapping biopsies may be indicated in specific situations for lesions that are solid (sessile) or if Tis or high-grade disease is suspected (eg, planned partial cystectomy, definitive chemoradiotherapy, evaluation of an unexplained positive urine cytology, certain clinical trials), random biopsies rarely yield positive results, especially for low-risk tumors. 12 Therefore, mapping biopsies of normal-appearing urothelium are not necessary for most patients.…”

Section: Clinical Presentation and Workupmentioning

confidence: 99%

Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Flaig

Spiess

Agarwal

et al. 2020

Journal of the National Comprehensive Cancer Network

471

389

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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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“…The transurethral resection of the bladder (TURB) is the usual management strategy for patients' diagnosis and treatment of low-grade NMIBC [14]. Immediate intravesical chemotherapy (usually mitomycin C) within 24 h of TURB was shown in some phase III clinical trials to decrease recurrence in selected patients [15][16][17]. Further treatment with intravesical induction (adjuvant) is advised for tumors with an intermediate or high risk of progression.…”

Section: Clinical Presentation and Managementmentioning

confidence: 99%

Biomarkers for Bladder Cancer Diagnosis and Surveillance: A Comprehensive Review

et al. 2020

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Bladder cancer (BC) ranks as the sixth most prevalent cancer in the world, with a steady rise in its incidence and prevalence, and is accompanied by a high morbidity and mortality. BC is a complex disease with several molecular and pathological pathways, thus reflecting different behaviors depending on the clinical staging of the tumor and molecular type. Diagnosis and monitoring of BC is mainly performed by invasive tests, namely periodic cystoscopies; this procedure, although a reliable method, is highly uncomfortable for the patient and it is not exempt of comorbidities. Currently, there is no formal indication for the use of molecular biomarkers in clinical practice, even though there are several tests available. There is an imperative need for a clinical non-invasive testing for early detection, disease monitoring, and treatment response in BC. In this review, we aim to assess and compare different tests based on molecular biomarkers and evaluate their potential role as new molecules for bladder cancer diagnosis, follow-up, and treatment response monitoring.

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Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non–Muscle-Invasive Bladder Cancer on Tumor Recurrence

Abstract: clinicaltrials.gov Identifier: NCT00445601.

Cited by 181 publications

References 40 publications

Update on the guideline of guidelines: non‐muscle‐invasive bladder cancer

Update on the guideline of guidelines: non‐muscle‐invasive bladder cancer

Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Biomarkers for Bladder Cancer Diagnosis and Surveillance: A Comprehensive Review

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