Safety and efficacy of various strains of bacille Calmette–Guérin in the treatment of bladder tumors in standard clinical practice

Unda-Urzaiz, M.; Cozar-Olmos, J.M.; Miñana-López, B.; Camarero-Jimenez, J.; Brugarolas-Rossello, X.; Zubiaur-Libano, C.; Ribal-Caparrós, M.J.; Suarez-Charneco, A.J.; Rodríguez-Tesedo, V.; Chantada-Abal, Venancio; Gonzalez-Ruiz-de-Leon, C.; Carrillo-George, Carlos; Carballido-Rodríguez, Joaquín; Villacampa-Aubá, F.

doi:10.1016/j.acuroe.2018.03.004

Cited by 14 publications

(20 citation statements)

References 21 publications

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“…A recent meta-analysis comparing 10 BCG substrains was unable to find the best substrain, 16 and a previously published retrospective study performed by Guerrero-Ramos et al found similar recurrence-free survival rates between patients who had received BCG Connaught and those who had received BCG Tice. 17 Similar conclusions were reached by Unda-Urzaiz et al, who compared BCG Tokyo, Russian, Tice, Connaught and RIVM; 18 Krajewski et al, who compared BCG Tice, Moreau and RIVM; 14 and a recent study that compared the BCG Moreau and Tice substrains. 19 However, Rentsh et al demonstrated that BCG Connaught was significantly more effective in terms of recurrence-free survival than BCG Tice.…”

Section: Safety and Efficacysupporting

confidence: 55%

<p>Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update</p>

Guallar-Garrido

Julián

2020

ITT

122

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Physicians treating patients affected by nonmuscle-invasive bladder cancer (NMIBC) have been in shock during the last six years since manufacturing restrictions on the production of the first-option medicine, Mycobacterium bovis Bacillus Calmette-Guérin (BCG), have resulted in worldwide shortages. This shortage of BCG has led to a rethinking of the established treatment guidelines for the rationing of the administration of BCG. Some possible schedule modifications consist of a decrease in the length of maintenance treatment, a reduction in the dose of BCG in intravesical instillations or the use of different BCG substrains. All these strategies have been considered valuable in times of BCG shortage. In addition, the lack of availability of BCG has also led to the general recognition of the need to find new treatment options for these patients so that they are not dependent on a single treatment. Few alternatives are committed to definitively replacing BCG intravesical instillations, but several options are being evaluated to improve its efficacy or to combine it with other chemotherapeutic or immunotherapeutic options that can also improve its effect. In this article, we review the current state of the treatment with BCG in terms of all of the aforementioned aspects.

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Section: Safety and Efficacysupporting

confidence: 55%

<p>Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update</p>

Guallar-Garrido

Julián

2020

ITT

122

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“…Finally, a meta-analysis of prospective RCTs and recent network meta-analysis including 10 different BCG strains did not confirm the superiority of any BCG strain over any other [15,16]. Similarly, recent data from a prospective study conducted by Unda- Urzaiz et al [17], as well as data from a post hoc analysis of a large Phase II prospective trial assessing BCG and interferon-α in both BCG-naive and BCG-failure patients [18] did not present any clear differences in oncological outcomes between various BCG strains.…”

Section: Discussionmentioning

confidence: 88%

Assessment of the oncological outcomes of three different bacillus Calmette–Guérin strains in patients with high-grade T1 non-muscle-invasive bladder cancer

Nowak

Krajewski

Moschini

et al. 2021

Arab Journal of Urology

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Objective: : To determine whether there are significant differences in oncological outcomes between three different bacillus Calmette-Guérin (BCG) strains used for adjuvant intravesical immunotherapy in patients with high-grade T1 (T1HG) non-muscle-invasive bladder cancer (NMIBC). Patients and methods: : Data of 590 patients with a diagnosis of primary T1HG NMIBC were retrospectively reviewed. The study included 138 (23.4%) patients who were treated with the Moreau, 272 (46.1%) with the TICE, and 180 (30.5%) with the RIVM strains. All patients included in the analysis received at least five instillations of an induction course and at least two installations of a maintenance course. Due to existing differences in baseline patient characteristics, the association between oncological outcomes and strain groups was investigated by complementary analysis with the implementation of inverse probability weighting (IPW). Results: : The 5-year recurrence-free survival (RFS) rate was 70.5%, 66.7% and 55.2% for the Moreau, TICE and RIVM groups, respectively (P = 0.016). The 5-year progression-free survival (PFS) rates were 84.4%, 85% and 77.8% in the Moreau, TICE and RIVM groups, respectively (P = 0.215). The IPW-adjusted Cox proportional hazard regression analysis did not show any differences in RFS between the Moreau and TICE groups (P = 0.69), whereas the RIVM strain was significantly associated with worse RFS compared to the Moreau (hazard ratio [HR] 1.69 for RIVM; P = 0.034) and TICE (HR 1.87 for RIVM; P = 0.002) strains. The IPW-adjusted analysis did not show any significant differences between study groups in terms of PFS. Conclusions: : The results of the present study suggest that the Moreau and TICE strains might be superior to the RIVM strain in terms of RFS in patients with T1HG NMIBC.

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“…In 43 of these studies (70%), BCG was used in all patients (100% treatment rate). 16,17,19,[21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][40][41][42][43][44]46,49,51,54,56,57,[61][62][63]65,68,69,[72][73][74][75][76] BCG therapy was an inclusion criterion for some of these studies, which contributed to this high rate. In the remaining 18 studies (30%), the reported use of BCG instillations in HR-NMIBC patients ranged from 3% to 86%.- 18,20,39,45,47,48,50,…”

Section: Treatment Patternsmentioning

confidence: 99%

“…In the remaining 18 studies (30%), the reported use of BCG instillations in HR-NMIBC patients ranged from 3% to 86%.- 18,20,39,45,47,48,50,52,53,55,[58][59][60]64,66,67,70,71 Thirty-five studies reported on the use of BCG induction therapy specifically, 16,17,20-22,24-28,31,33-37,40,42,45,47,49,51,52, ClinicoEconomics and Outcomes Research 2022:14 https://doi.org/10.2147/CEOR.S341896 DovePress 37 54,56,57,59,61,63,65,68,74,75,77,78 of which 27 (77%) reported the use of BCG induction in all patients (100%). 16,17,21,22,[24][25][26][27][28]31,[33][34][35][36][37]40,42,49,…”

Section: Treatment Patternsmentioning

confidence: 99%

Treatment Outcomes of High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in Real-World Evidence (RWE) Studies: Systematic Literature Review (SLR)

Musat¹,

Kwon²,

Masters³

et al. 2022

CEOR

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Background: To date, there has been limited synthesis of RWE studies in high-risk nonmuscle invasive bladder cancer (HR-NMIBC). The objective of this research was to conduct a systematic review of published real-world evidence to better understand the real-world burden and treatment patterns in HR-NMIBC. Methods: An SLR was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines with the scope defined by the Population, Intervention Comparators, Outcomes, and Study design (PICOS) criteria. EMBASE, MEDLINE, and Cochrane databases (Jan 2015-Jul 2020) were searched, and relevant congress abstracts (Jan 2018-Jul 2020) identified. The final analysis only included studies that enrolled ≥100 patients with HR-NMIBC from the US, Europe, Canada, and Australia. Results: The SLR identified 634 RWE publications in NMIBC, of which 160 studies reported data in HR-NMIBC. The average age of patients in the studies was 71 years, and 79% were males. The rates of BCG intravesical instillations ranged from 3% to 86% (29-95% for induction and 8-83% for maintenance treatment). Five-year outcomes were 17-89% recurrence-free survival (longest survival in patients completing BCG maintenance), 58-89% progression-free survival, 71-96% cancer-specific survival (lowest survival in BCG-unresponsive patients), and 28-90% overall survival (lowest survival in patients who did not receive BCG or instillation therapy). Conclusion: BCG treatment rates and survival outcomes in patients with HR-NMIBC vary in the real world, with better survival seen in patients completing maintenance BCG, responding to treatment, and not progressing to muscle-invasive disease. There is a need to better understand the factors associated with BCG use and discontinuation and for an effective treatment that improves outcomes in HR-NMIBC. Generalization of these results is limited by variations in data collection, reporting, and methodologies used across RWE studies.

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Safety and efficacy of various strains of bacille Calmette–Guérin in the treatment of bladder tumors in standard clinical practice

Cited by 14 publications

References 21 publications

<p>Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update</p>

<p>Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update</p>

Assessment of the oncological outcomes of three different bacillus Calmette–Guérin strains in patients with high-grade T1 non-muscle-invasive bladder cancer

Treatment Outcomes of High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in Real-World Evidence (RWE) Studies: Systematic Literature Review (SLR)

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