International Bladder Cancer Group Consensus Statement on Clinical Trial Design for Patients with Bacillus Calmette-Guérin–exposed High-risk Non–muscle-invasive Bladder Cancer
Published 2021 View Full Article
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Title
International Bladder Cancer Group Consensus Statement on Clinical Trial Design for Patients with Bacillus Calmette-Guérin–exposed High-risk Non–muscle-invasive Bladder Cancer
Authors
Keywords
Non–muscle-invasive bladder cancer, Bacillus Calmette-Guérin, Intravesical therapy, Risk stratification, Clinical trials
Journal
EUROPEAN UROLOGY
Volume -, Issue -, Pages -
Publisher
Elsevier BV
Online
2021-12-24
DOI
10.1016/j.eururo.2021.12.005
References
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Related references
Note: Only part of the references are listed.- European Association of Urology (EAU) Prognostic Factor Risk Groups for Non–muscle-invasive Bladder Cancer (NMIBC) Incorporating the WHO 2004/2016 and WHO 1973 Classification Systems for Grade: An Update from the EAU NMIBC Guidelines Panel
- (2021) Richard J. Sylvester et al. EUROPEAN UROLOGY
- Phase II/III clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients.
- (2021) Karim Chamie et al. JOURNAL OF CLINICAL ONCOLOGY
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- A Systematic Review of Outcome Reporting, Definition and Measurement Heterogeneity in Non-Muscle Invasive Bladder Cancer Effectiveness Trials of Adjuvant, Prophylactic Treatment After Transurethral Resection
- (2021) Erik Veskimae et al. Bladder Cancer
- Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816).
- (2021) Peter C. Black et al. JOURNAL OF CLINICAL ONCOLOGY
- Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study
- (2021) Arjun V Balar et al. LANCET ONCOLOGY
- Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma
- (2021) Dean F. Bajorin et al. NEW ENGLAND JOURNAL OF MEDICINE
- Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial
- (2020) Stephen A Boorjian et al. LANCET ONCOLOGY
- Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non–Muscle-Invasive Bladder Cancer on Tumor Recurrence
- (2018) Edward M. Messing et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Prognostic Implication of the United States Food and Drug Administration-defined BCG-unresponsive Disease
- (2018) Roger Li et al. EUROPEAN UROLOGY
- An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non–muscle-invasive bladder cancer: Interim results
- (2017) Vignesh T. Packiam et al. UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS
- Papillary Recurrence of Bladder Cancer at First Evaluation after Induction Bacillus Calmette-Guérin Therapy: Implication for Clinical Trial Design
- (2016) Chinedu O. Mmeje et al. EUROPEAN UROLOGY
- Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa–pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation?
- (2016) Richard J. Sylvester et al. EUROPEAN UROLOGY
- Definitions, End Points, and Clinical Trial Designs for Non–Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group
- (2016) Ashish M. Kamat et al. JOURNAL OF CLINICAL ONCOLOGY
- Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline
- (2016) Sam S. Chang et al. JOURNAL OF UROLOGY
- Defining and Treating the Spectrum of Intermediate Risk Nonmuscle Invasive Bladder Cancer
- (2014) Ashish M. Kamat et al. JOURNAL OF UROLOGY
- SWOG S0353: Phase II Trial of Intravesical Gemcitabine in Patients with Nonmuscle Invasive Bladder Cancer and Recurrence after 2 Prior Courses of Intravesical Bacillus Calmette-Guérin
- (2013) Eila C. Skinner et al. JOURNAL OF UROLOGY
- The questionable use of unequal allocation in confirmatory trials
- (2013) S. P. Hey et al. NEUROLOGY
- Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop
- (2013) Jonathan P. Jarow et al. UROLOGY
- Prognostic significance of Bacillus Calmette-Guérin failure classification in non-muscle-invasive bladder cancer
- (2012) Hiroshi Shirakawa et al. BJU INTERNATIONAL
- Final Results of an EORTC-GU Cancers Group Randomized Study of Maintenance Bacillus Calmette-Guérin in Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Urinary Bladder: One-third Dose Versus Full Dose and 1 Year Versus 3 Years of Maintenance
- (2012) Jorg Oddens et al. EUROPEAN UROLOGY
- Impact of Previous Bacille Calmette-Guérin Failure Pattern on Subsequent Response to Bacille Calmette-Guérin Plus Interferon Intravesical Therapy
- (2008) Brian L. Gallagher et al. UROLOGY
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