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The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer

BACKGROUND: Intravesical bacillus Calmette-Guérin (BCG) instillation is a standard treatment for non–muscle-invasive bladder cancer (NMIBC); however, not all patients benefit from BCG therapy. Currently, no surrogate marker exists to predict BCG efficacy, and thereby, identify patients who will bene...

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Autores principales: Muto, Satoru, Lu, Yan, Ide, Hisamitsu, Yamaguchi, Raizo, Saito, Keisuke, Kitamura, Kousuke, Noma, Yasuhiro, Koyasu, Hiroki, Hirano, Hisashi, Ashizawa, Takeshi, Isotani, Shuji, Nagata, Masayoshi, Horie, Shigeo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317891/
https://www.ncbi.nlm.nih.gov/pubmed/34337512
http://dx.doi.org/10.1016/j.euros.2021.02.005
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author Muto, Satoru
Lu, Yan
Ide, Hisamitsu
Yamaguchi, Raizo
Saito, Keisuke
Kitamura, Kousuke
Noma, Yasuhiro
Koyasu, Hiroki
Hirano, Hisashi
Ashizawa, Takeshi
Isotani, Shuji
Nagata, Masayoshi
Horie, Shigeo
author_facet Muto, Satoru
Lu, Yan
Ide, Hisamitsu
Yamaguchi, Raizo
Saito, Keisuke
Kitamura, Kousuke
Noma, Yasuhiro
Koyasu, Hiroki
Hirano, Hisashi
Ashizawa, Takeshi
Isotani, Shuji
Nagata, Masayoshi
Horie, Shigeo
author_sort Muto, Satoru
collection PubMed
description BACKGROUND: Intravesical bacillus Calmette-Guérin (BCG) instillation is a standard treatment for non–muscle-invasive bladder cancer (NMIBC); however, not all patients benefit from BCG therapy. Currently, no surrogate marker exists to predict BCG efficacy, and thereby, identify patients who will benefit from this treatment. OBJECTIVE: To evaluate the utility of urine Mycobacterium tuberculosis complex polymerase chain reaction (MTC-PCR) assay as a predictive marker for recurrence and progression following BCG therapy. DESIGN, SETTING, AND PARTICIPANTS: A prospective analysis was carried out for of intermediate- or high-risk NMIBC patients who received BCG instillation for the first time. Urine samples, for MTC-PCR assay, were collected at baseline and annually for up to 10 yr after the last BCG instillation, including induction and maintenance therapy. The first postoperative sample for MTC-PCR was taken at 1 yr from the last instillation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis was performed using the Kaplan-Meier method, and risk factors for recurrence and progression after BCG treatment were assessed using Cox regression analysis. RESULTS AND LIMITATIONS: During follow-up (median: 57 mo), 468/521 samples (89.8%) were MTC-PCR positive, and 108/123 patients (87.8%) exhibited MTC-PCR positivity at least once. Five-year recurrence- and progression-free survival in patients who were not MTC-PCR positive was significantly lower than in patients who were MTC-PCR positive at least once (p <  0.001). Using multivariable Cox regression analysis, MTC-PCR positivity at least once was a significant prognostic factor for recurrence (hazard ratio [HR]: 36.782, p <  0.001) and progression (HR: 47.209, p <  0.001). CONCLUSIONS: Patients who were not MTC-PCR positive, even once after BCG therapy, were extremely likely to exhibit recurrence and progression. Urine MTC-PCR may be an extremely useful, noninvasive surrogate marker to predict recurrence and progression following BCG therapy. PATIENT SUMMARY: Urine Mycobacterium tuberculosis complex polymerase chain reaction may be a novel biomarker capable of identifying patients at risk of recurrence and progression after bacillus Calmette-Guérin (BCG) immunotherapy.
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spelling pubmed-83178912021-07-29 The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer Muto, Satoru Lu, Yan Ide, Hisamitsu Yamaguchi, Raizo Saito, Keisuke Kitamura, Kousuke Noma, Yasuhiro Koyasu, Hiroki Hirano, Hisashi Ashizawa, Takeshi Isotani, Shuji Nagata, Masayoshi Horie, Shigeo Eur Urol Open Sci Bladder Cancer BACKGROUND: Intravesical bacillus Calmette-Guérin (BCG) instillation is a standard treatment for non–muscle-invasive bladder cancer (NMIBC); however, not all patients benefit from BCG therapy. Currently, no surrogate marker exists to predict BCG efficacy, and thereby, identify patients who will benefit from this treatment. OBJECTIVE: To evaluate the utility of urine Mycobacterium tuberculosis complex polymerase chain reaction (MTC-PCR) assay as a predictive marker for recurrence and progression following BCG therapy. DESIGN, SETTING, AND PARTICIPANTS: A prospective analysis was carried out for of intermediate- or high-risk NMIBC patients who received BCG instillation for the first time. Urine samples, for MTC-PCR assay, were collected at baseline and annually for up to 10 yr after the last BCG instillation, including induction and maintenance therapy. The first postoperative sample for MTC-PCR was taken at 1 yr from the last instillation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis was performed using the Kaplan-Meier method, and risk factors for recurrence and progression after BCG treatment were assessed using Cox regression analysis. RESULTS AND LIMITATIONS: During follow-up (median: 57 mo), 468/521 samples (89.8%) were MTC-PCR positive, and 108/123 patients (87.8%) exhibited MTC-PCR positivity at least once. Five-year recurrence- and progression-free survival in patients who were not MTC-PCR positive was significantly lower than in patients who were MTC-PCR positive at least once (p <  0.001). Using multivariable Cox regression analysis, MTC-PCR positivity at least once was a significant prognostic factor for recurrence (hazard ratio [HR]: 36.782, p <  0.001) and progression (HR: 47.209, p <  0.001). CONCLUSIONS: Patients who were not MTC-PCR positive, even once after BCG therapy, were extremely likely to exhibit recurrence and progression. Urine MTC-PCR may be an extremely useful, noninvasive surrogate marker to predict recurrence and progression following BCG therapy. PATIENT SUMMARY: Urine Mycobacterium tuberculosis complex polymerase chain reaction may be a novel biomarker capable of identifying patients at risk of recurrence and progression after bacillus Calmette-Guérin (BCG) immunotherapy. Elsevier 2021-03-11 /pmc/articles/PMC8317891/ /pubmed/34337512 http://dx.doi.org/10.1016/j.euros.2021.02.005 Text en © 2021 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Bladder Cancer
Muto, Satoru
Lu, Yan
Ide, Hisamitsu
Yamaguchi, Raizo
Saito, Keisuke
Kitamura, Kousuke
Noma, Yasuhiro
Koyasu, Hiroki
Hirano, Hisashi
Ashizawa, Takeshi
Isotani, Shuji
Nagata, Masayoshi
Horie, Shigeo
The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer
title The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer
title_full The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer
title_fullStr The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer
title_full_unstemmed The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer
title_short The Use of Urine Mycobacterium tuberculosis Complex Polymerase Chain Reaction as a Predictive Factor for Recurrence and Progression After Intravesical Bacillus Calmette-Guérin Therapy in Patients with Non–muscle‑invasive Bladder Cancer
title_sort use of urine mycobacterium tuberculosis complex polymerase chain reaction as a predictive factor for recurrence and progression after intravesical bacillus calmette-guérin therapy in patients with non–muscle‑invasive bladder cancer
topic Bladder Cancer
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317891/
https://www.ncbi.nlm.nih.gov/pubmed/34337512
http://dx.doi.org/10.1016/j.euros.2021.02.005
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