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Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease

Objective: To create the first data-driven definition for those unlikely to benefit from further BCG treatment. Materials and Methods: The database created for the Phase 2 BCG-Interferon-α 2B (IFN) study was queried and BCG failure patients were identified (n = 334). Full study protocols have previo...

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Autores principales: Steinberg, Ryan L., Thomas, Lewis J., Mott, Sarah L., O’Donnell, Michael A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: IOS Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927860/
https://www.ncbi.nlm.nih.gov/pubmed/27376140
http://dx.doi.org/10.3233/BLC-150039
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author Steinberg, Ryan L.
Thomas, Lewis J.
Mott, Sarah L.
O’Donnell, Michael A.
author_facet Steinberg, Ryan L.
Thomas, Lewis J.
Mott, Sarah L.
O’Donnell, Michael A.
author_sort Steinberg, Ryan L.
collection PubMed
description Objective: To create the first data-driven definition for those unlikely to benefit from further BCG treatment. Materials and Methods: The database created for the Phase 2 BCG-Interferon-α 2B (IFN) study was queried and BCG failure patients were identified (n = 334). Full study protocols have previously been published. Separate models were constructed for analysis of patients with any CIS (pure or concomitant) and pure papillary disease. Variables considered included age, gender, stage, grade, tumor size and focality (for papillary only), number of prior BCG courses, and prior BCG failure interval. Results: Patients with recurrent CIS within 6 months of their most recent prior BCG course (HR 2.56, p <  0.01) and ≥2 prior BCG failures (HR 1.54, p <  0.01) responded worst to repeat intravesical therapy. Those with CIS recurrence at 6–12 months did not differ from those recurring within 6 months (HR = 0.88, p = 0.71). Patients with recurrent papillary disease within 6 months (HR 1.82, p = 0.02), ≥2 BCG failures (HR 1.54, p = 0.03), and multifocal disease (HR 2.05, p <  0.01) responded worst to therapy. Patients with T1 disease remained disease free in 38% of cases (24–51% 95% CI) at 2 years with low rates of progression. Conclusions: Patients who fail two courses of BCG with either persistent or recurrent multifocal papillary disease within 6 months or CIS within 12 months of their prior BCG should be considered BCG unresponsive. Recurrent T1 disease respond reasonably well to another course with low progression rates but further investigation is warranted.
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spelling pubmed-49278602016-06-30 Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease Steinberg, Ryan L. Thomas, Lewis J. Mott, Sarah L. O’Donnell, Michael A. Bl Cancer Research Report Objective: To create the first data-driven definition for those unlikely to benefit from further BCG treatment. Materials and Methods: The database created for the Phase 2 BCG-Interferon-α 2B (IFN) study was queried and BCG failure patients were identified (n = 334). Full study protocols have previously been published. Separate models were constructed for analysis of patients with any CIS (pure or concomitant) and pure papillary disease. Variables considered included age, gender, stage, grade, tumor size and focality (for papillary only), number of prior BCG courses, and prior BCG failure interval. Results: Patients with recurrent CIS within 6 months of their most recent prior BCG course (HR 2.56, p <  0.01) and ≥2 prior BCG failures (HR 1.54, p <  0.01) responded worst to repeat intravesical therapy. Those with CIS recurrence at 6–12 months did not differ from those recurring within 6 months (HR = 0.88, p = 0.71). Patients with recurrent papillary disease within 6 months (HR 1.82, p = 0.02), ≥2 BCG failures (HR 1.54, p = 0.03), and multifocal disease (HR 2.05, p <  0.01) responded worst to therapy. Patients with T1 disease remained disease free in 38% of cases (24–51% 95% CI) at 2 years with low rates of progression. Conclusions: Patients who fail two courses of BCG with either persistent or recurrent multifocal papillary disease within 6 months or CIS within 12 months of their prior BCG should be considered BCG unresponsive. Recurrent T1 disease respond reasonably well to another course with low progression rates but further investigation is warranted. IOS Press 2016-04-27 /pmc/articles/PMC4927860/ /pubmed/27376140 http://dx.doi.org/10.3233/BLC-150039 Text en IOS Press and the authors. All rights reserved https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial (CC BY-NC 4.0) License (https://creativecommons.org/licenses/by-nc/4.0/) , which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Report
Steinberg, Ryan L.
Thomas, Lewis J.
Mott, Sarah L.
O’Donnell, Michael A.
Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease
title Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease
title_full Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease
title_fullStr Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease
title_full_unstemmed Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease
title_short Bacillus Calmette-Guérin (BCG) Treatment Failures with Non-Muscle Invasive Bladder Cancer: A Data-Driven Definition for BCG Unresponsive Disease
title_sort bacillus calmette-guérin (bcg) treatment failures with non-muscle invasive bladder cancer: a data-driven definition for bcg unresponsive disease
topic Research Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927860/
https://www.ncbi.nlm.nih.gov/pubmed/27376140
http://dx.doi.org/10.3233/BLC-150039
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