Journal article
Evidence-based Assessment of Current and Emerging Bladder - sparing Therapies for Non-muscle-invasive Bladder Cancer After Bacillus Calmette-Guerin Therapy: A Systematic Review and Meta-analysis
European urology oncology, Vol.3(3), pp.318-340
06/01/2020
DOI: 10.1016/j.euo.2020.02.006
PMID: 32201133
Abstract
Context: Currently, there is no standard of care for patients with non-muscle-invasive bladder cancer (NMIBC) who recur despite bacillus Calmette-Guerin (BCG) therapy. Although radical cystectomy is recommended, many patients decline to undergo or are ineligible to receive it. Multiple agents are being investigated for use in this patient population.
Objective: To systematically synthesize and describe the efficacy and safety of current and emerging treatments for NMIBC patients after treatment with BCG.
Evidence acquisition: A systematic literature search of MEDLINE, Embase, and the Cochrane Controlled Register of Trials (period limited to January 2007-June 2019) was performed. Abstracts and presentations from major conference proceedings were also reviewed. Randomized controlled trials were assessed using the Cochrane risk of bias tool. Data for single-arm trials were pooled using a random-effect meta-analysis with the proportions approach. Trials were grouped based on the minimum number of prior BCG courses required before enrollment and further stratified based on the proportion of patients with carcinoma in situ (CIS).
Evidence synthesis: Thirty publications were identified with data from 23 trials for meta-analysis, of which 17 were single arm. Efficacy and safety outcomes varied widely across studies. Heterogeneity across trials was reduced in subgroup analyses. The pooled 12-mo response rates were 24% (95% confidence interval [CI]: 16-32%) for trials with two or more prior BCG courses and 36% (95% CI: 25-47%) for those with one or more prior BCG courses. In a subgroup analysis, inclusion of >= 50% of patients with CIS was associated with a lower response.
Conclusions: The variability in efficacy and safety outcomes highlights the need for consistent endpoint reporting and patient population definitions. With promising emerging treatments currently in development, efficacious and safe therapeutic options are urgently needed for this difficult-to-treat patient population.
Patient summary: We examined the efficacy and safety outcomes of treatments for non-muscle-invasive bladder cancer after bacillus Calmette-Guerin therapy. Outcomes varied across studies and patient populations, but emerging treatments currently in development show promising efficacy. (C) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Details
- Title: Subtitle
- Evidence-based Assessment of Current and Emerging Bladder - sparing Therapies for Non-muscle-invasive Bladder Cancer After Bacillus Calmette-Guerin Therapy: A Systematic Review and Meta-analysis
- Creators
- Ashish M. Kamat - The University of Texas MD Anderson Cancer CenterSeth P. Lerner - Baylor College of MedicineMichael O'Donnell - Univ Iowa, Iowa City, IA USAMihaela V. Georgieva - Analysis GroupMin Yang - Analysis GroupBrant A. Inman - Duke UniversityWassim Kassouf - McGill University Health CentreStephen A. Boorjian - Mayo Clinic in ArizonaMark D. Tyson - Mayo Clinic HospitalGirish S. Kulkarni - University of TorontoSam S. Chang - Vanderbilt UniversityBadrinath R. Konety - University of MinnesotaRobert S. Svatek - The University of Texas at AustinArjun Balar - NYU Langone HealthJ. Alfred Witjes - Radboud University Medical Center
- Resource Type
- Journal article
- Publication Details
- European urology oncology, Vol.3(3), pp.318-340
- Publisher
- Elsevier
- DOI
- 10.1016/j.euo.2020.02.006
- PMID
- 32201133
- ISSN
- 2588-9311
- eISSN
- 2588-9311
- Number of pages
- 23
- Grant note
- FerGene Inc. (USA)
- Language
- English
- Date published
- 06/01/2020
- Academic Unit
- Urology
- Record Identifier
- 9984320071502771
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