1786 A PROSPECTIVE COMPARATIVE STUDY OF INTRAVESICAL BACILLUS CALMETTE-GUERIN (BCG) THERAPY WITH THE TOKYO OR CONNAUGHT STRAINS FOR NON-MUSCLE INVASIVE BLADDER CANCER

2013 ◽  
Vol 189 (4S) ◽  
Author(s):  
Atsushi Sengiku ◽  
Masaaki Ito ◽  
Yu Miyazaki ◽  
Harutake Sawazaki ◽  
Takeshi Takahashi ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Comparative Study ◽  
Invasive Bladder Cancer ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Bcg Therapy ◽  
Prospective Comparative Study ◽  
Muscle Invasive

scholarly journals Clinicopathological Criteria Predictive of Recurrence Following Bacillus Calmette-Guérin in Non–Muscle-Invasive Bladder Cancer (Preprint)

2020 ◽  
Author(s):  
Joseph Plasek ◽  
John Weissert ◽  
Tracy Downs ◽  
Kyle Richards ◽  
Kourosh Ravvaz
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Univariate Analysis ◽  
Neutrophil To Lymphocyte Ratio ◽  
Invasive Bladder Cancer ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Lymphocyte Ratio ◽  
Bcg Therapy ◽  
Muscle Invasive

BACKGROUND Bacillus Calmette-Guérin (BCG) is currently the most clinically effective intravesical treatment for non–muscle-invasive bladder cancer (NMIBC), particularly for patients with high-risk NMIBC such as those with carcinoma in-situ (CIS). BCG treatments could be optimized to improve patient safety and conserve supply by predicting BCG efficacy with tumor characteristics or clinicopathological criteria. OBJECTIVE To assess the ability of specific clinicopathological criteria to predict tumor recurrence in patients with NMIBC who received BCG along various treatment timelines. METHODS A total of 1331 patients (Stage Ta, T1, or CIS) who underwent transurethral resection of a bladder tumor (TUR) between 2006 and 2017 were included. Univariate analysis including laboratory tests (e.g. complete blood panels, creatinine levels, Hemoglobin A1c levels) within 180 days post-BCG therapy initiation, medications, and clinical and demographic variables to assess their ability to predict NMIBC recurrence was completed. This was followed by multivariate regression that included the elements of Club Urológico Español de Tratamiento Oncológico (CUETO) and variables that were significant predictors of recurrence in univariate analysis. RESULTS BCG was administered to 183 intermediate- or high-risk patients, and 76 (41.5%) experienced disease recurrence. Abnormal neutrophil-to-lymphocyte ratio measured within 180 days post-induction BCG was a significant predictor (p<0.05) of future cancer recurrence and was a stronger predictor than CUETO or the individual variables included in CUETO via multivariate analysis. CONCLUSIONS Abnormal neutrophil-to-lymphocyte ratio within 180 days following BCG is predictive of recurrence and could be a suggestive for additional or alternative interventions. CLINICALTRIAL N/A

scholarly journals Intravesical rAd–IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin–Refractory or Relapsed Non–Muscle-Invasive Bladder Cancer: A Phase II Randomized Study

2017 ◽  
Vol 35 (30) ◽  
pp. 3410-3416 ◽  
Author(s):  
Neal D. Shore ◽  
Stephen A. Boorjian ◽  
Daniel J. Canter ◽  
Kenneth Ogan ◽  
Lawrence I. Karsh ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Phase Ii ◽  
Recombinant Adenovirus ◽  
Invasive Bladder Cancer ◽  
High Grade ◽  
Bacillus Calmette Guerin ◽  
Efficacy And Safety ◽  
Muscle Invasive Bladder Cancer ◽  
Bcg Therapy ◽  
Muscle Invasive

Purpose Many patients with high-risk non–muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd–IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC. Methods In this open-label, multicenter (n = 13), parallel-arm, phase II study ( ClinicalTrials.gov identifier: NCT01687244), 43 patients with HG BCG-refractory or relapsed NMIBC received intravesical rAd–IFNα/Syn3 (randomly assigned 1:1 to 1 × 1011 viral particles (vp)/mL or 3 × 1011 vp/mL). Patients who responded at months 3, 6, and 9 were retreated at months 4, 7, and 10. The primary end point was 12-month HG recurrence-free survival (RFS). All patients who received at least one dose were included in efficacy and safety analyses. Results Forty patients received rAd–IFNα/Syn3 (1 × 1011 vp/mL, n = 21; 3 × 1011 vp/mL, n = 19) between November 5, 2012, and April 8, 2015. Fourteen patients (35.0%; 90% CI, 22.6% to 49.2%) remained free of HG recurrence 12 months after initial treatment. Comparable 12-month HG RFS was noted for both doses. Of these 14 patients, two experienced recurrence at 21 and 28 months, respectively, after treatment initiation, and one died as a result of an upper tract tumor at 17 months without a recurrence. rAd–IFNα/Syn3 was well tolerated; no grade four or five adverse events (AEs) occurred, and no patient discontinued treatment because of an adverse event. The most frequently reported drug-related AEs were micturition urgency (n = 16; 40%), dysuria (n = 16; 40%), fatigue (n = 13; 32.5%), pollakiuria (n = 11; 28%), and hematuria and nocturia (n = 10 each; 25%). Conclusion rAd—IFNα/Syn3 was well tolerated. It demonstrated promising efficacy for patients with HG NMIBC after BCG therapy who were unable or unwilling to undergo radical cystectomy.

scholarly journals A Molecular Signature Determines the Prognostic and Therapeutic Subtype of Non-Muscle-Invasive Bladder Cancer Responsive to Intravesical Bacillus Calmette-Guérin Therapy

2021 ◽  
Vol 22 (3) ◽  
pp. 1450
Author(s):  
Seon-Kyu Kim ◽  
Seong-Hwan Park ◽  
Yeong Uk Kim ◽  
Young Joon Byun ◽  
Xuan-Mei Piao ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Molecular Subtypes ◽  
Molecular Signature ◽  
Invasive Bladder Cancer ◽  
Diagnostic Tools ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Free Survival ◽  
Bcg Therapy ◽  
Muscle Invasive

Non-muscle-invasive bladder cancer (NMIBC) is clinically heterogeneous; thus, many patients fail to respond to treatment and relapse. Here, we identified a molecular signature that is both prognostic and predictive for NMIBC heterogeneity and responses to Bacillus Calmette-Guérin (BCG) therapy. Transcriptomic profiling of 948 NMIBC patients identified a signature-based subtype predictor, MSP888, along with three distinct molecular subtypes: DP.BCG+ (related to progression and response to BCG treatment), REC.BCG+ (related to recurrence and response to BCG treatment), and EP (equivocal prognosis). Patients with the DP.BCG+ subtype showed worse progression-free survival but responded to BCG treatment, whereas those with the REC.BCG+ subtype showed worse recurrence-free survival but responded to BCG treatment. Multivariate analyses revealed that MSP888 showed independent clinical utility for predicting NMIBC prognosis (each p = 0.001 for progression and recurrence, respectively). Comparative analysis of this classifier and previously established molecular subtypes (i.e., Lund taxonomy and UROMOL class) revealed that a great proportion of patients were similar between subtypes; however, the MSP888 predictor better differentiated biological activity or responsiveness to BCG treatment. Our data increase our understanding of the mechanisms underlying the poor prognosis of NMIBC and the effectiveness of BCG therapy, which should improve clinical practice and complement other diagnostic tools.

Management of Non–Muscle-Invasive Bladder Cancer

2018 ◽  
Author(s):  
Peter C Black
Keyword(s):  
Bladder Cancer ◽  
Narrow Band Imaging ◽  
High Rate ◽  
Invasive Bladder Cancer ◽  
Optimal Timing ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Key Words Bladder Cancer ◽  
Bcg Therapy ◽  
Muscle Invasive

Non–muscle-invasive bladder cancer (NMIBC) makes up 75% of the fifth most common cancer in North America. With a high rate of recurrence and progression, which leads to significant treatment burden for patients and high costs to healthcare systems, NMIBC poses several critical clinical challenges. Enhanced cystoscopic techniques are improving detection and optimal resection of these tumors. The administration of intravesical therapies, including especially cytotoxic chemotherapy and bacillus Calmette-Guérin (BCG) therapy, continues to evolve, and several promising agents are under development. Refined definitions of treatment failure are promoting clinical trial activity in this domain. The optimal timing of radical cystectomy for BCG therapy–unresponsive patients continues to be a key unresolved question, but advances in the molecular characterization of NMIBC are likely to enhance individualized, risk-adapted therapy in the near future.   This review contains 3 Figures, 10 Tables and 91 references Key words: bladder cancer; cystoscopy; narrow band imaging; fluorescence cystoscopy; transurethral resection of bladder tumor (TURBT); intravesical chemotherapy; bacillus Calmette-Guérin (BCG) therapy; urine markers.

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