Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials
Purpose: Intravesical BCG (bacille Calmette–Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BC...
Main Authors: | , , , , , , , |
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Format: | Article |
Language: | English |
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Korean Urological Association
2022-03-01
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Series: | Investigative and Clinical Urology |
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Online Access: | https://www.icurology.org/pdf/10.4111/icu.20210340 |
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author | Se Young Choi Moon Soo Ha Jung Hoon Kim Byung Hoon Chi Jin Wook Kim In Ho Chang Tae-Hyoung Kim Soon Chul Myung |
author_facet | Se Young Choi Moon Soo Ha Jung Hoon Kim Byung Hoon Chi Jin Wook Kim In Ho Chang Tae-Hyoung Kim Soon Chul Myung |
author_sort | Se Young Choi |
collection | DOAJ |
description | Purpose: Intravesical BCG (bacille Calmette–Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BCG that could maintain efficacy and reduce adverse effects.
Materials and Methods: We conducted a comprehensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Science, and Scopus to identify randomized controlled trials through April 2021. The odds ratios (ORs) and 95% confidence intervals (CIs) for the low and standard doses in nine studies were compared. A low dose was defined as a low volume of BCG compared with the standard BCG dose (Armand Frappier, 120 mg; Connaught, 81 mg; Danish 1331, 120 mg; modified Danish 1331, 120 mg; Tokyo 172, 80 mg).
Results: The low-dose group experienced aggravated recurrence (OR, 1.45; 95% CI, 1.09–1.94; p=0.01) but similar progression (OR, 1.11; 95% CI, 0.76–1.62; p=0.59), similar cancer-specific survival (OR, 1.02; 95% CI, 0.60–1.75; p=0.93), similar overall survival (OR, 1.09; 95% CI, 0.76–1.56; p=0.65), favorable adverse effects (OR, 0.41; 95% CI, 0.28–0.62; p<0.0001), and favorable withdrawal (OR, 0.42; 95% CI, 0.25–0.71; p=0.001).
Conclusions: Low-dose BCG had more unfavorable outcomes than did standard-dose BCG in terms of recurrence. Tumor progression, cancer-specific survival, and overall survival were similar between the doses. Low-dose BCG improved adverse effects and withdrawal. In the setting of BCG shortage, low-dose BCG may have strong potential as an alternative. |
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id | doaj.art-9152b9ee23bb4d2fa261967ae79f95d6 |
institution | Directory Open Access Journal |
issn | 2466-0493 2466-054X |
language | English |
last_indexed | 2024-12-17T12:40:43Z |
publishDate | 2022-03-01 |
publisher | Korean Urological Association |
record_format | Article |
series | Investigative and Clinical Urology |
spelling | doaj.art-9152b9ee23bb4d2fa261967ae79f95d62022-12-21T21:48:01ZengKorean Urological AssociationInvestigative and Clinical Urology2466-04932466-054X2022-03-0163214015010.4111/icu.20210340Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trialsSe Young Choi 0https://orcid.org/0000-0002-4615-0966Moon Soo Ha1https://orcid.org/0000-0001-9735-4347Jung Hoon Kim2https://orcid.org/0000-0002-0947-876XByung Hoon Chi 3https://orcid.org/0000-0002-4184-7780Jin Wook Kim4https://orcid.org/0000-0003-4157-9365In Ho Chang5https://orcid.org/0000-0003-0240-1310Tae-Hyoung Kim6https://orcid.org/0000-0002-0257-3449Soon Chul Myung7https://orcid.org/0000-0002-6727-5450Department of Urology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.Department of Urology, Hyundae General Hospital, Chung-Ang University College of Medicine, Namyangju, Korea.Department of Urology, Hanil General Hospital, Seoul, Korea.Department of Urology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.Department of Urology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.Department of Urology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.Department of Urology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.Department of Urology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.Purpose: Intravesical BCG (bacille Calmette–Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BCG that could maintain efficacy and reduce adverse effects. Materials and Methods: We conducted a comprehensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Science, and Scopus to identify randomized controlled trials through April 2021. The odds ratios (ORs) and 95% confidence intervals (CIs) for the low and standard doses in nine studies were compared. A low dose was defined as a low volume of BCG compared with the standard BCG dose (Armand Frappier, 120 mg; Connaught, 81 mg; Danish 1331, 120 mg; modified Danish 1331, 120 mg; Tokyo 172, 80 mg). Results: The low-dose group experienced aggravated recurrence (OR, 1.45; 95% CI, 1.09–1.94; p=0.01) but similar progression (OR, 1.11; 95% CI, 0.76–1.62; p=0.59), similar cancer-specific survival (OR, 1.02; 95% CI, 0.60–1.75; p=0.93), similar overall survival (OR, 1.09; 95% CI, 0.76–1.56; p=0.65), favorable adverse effects (OR, 0.41; 95% CI, 0.28–0.62; p<0.0001), and favorable withdrawal (OR, 0.42; 95% CI, 0.25–0.71; p=0.001). Conclusions: Low-dose BCG had more unfavorable outcomes than did standard-dose BCG in terms of recurrence. Tumor progression, cancer-specific survival, and overall survival were similar between the doses. Low-dose BCG improved adverse effects and withdrawal. In the setting of BCG shortage, low-dose BCG may have strong potential as an alternative.https://www.icurology.org/pdf/10.4111/icu.20210340administrationintravesicaladverse effectsrecurrenceurinary bladder neoplasms |
spellingShingle | Se Young Choi Moon Soo Ha Jung Hoon Kim Byung Hoon Chi Jin Wook Kim In Ho Chang Tae-Hyoung Kim Soon Chul Myung Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials Investigative and Clinical Urology administration intravesical adverse effects recurrence urinary bladder neoplasms |
title | Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials |
title_full | Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials |
title_fullStr | Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials |
title_full_unstemmed | Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials |
title_short | Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials |
title_sort | low dose versus standard dose bacille calmette guerin for non muscle invasive bladder cancer systematic review and meta analysis of randomized controlled trials |
topic | administration intravesical adverse effects recurrence urinary bladder neoplasms |
url | https://www.icurology.org/pdf/10.4111/icu.20210340 |
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