Risk factor assessment in high-risk, bacillus Calmette&amp;ndash;Gu&amp;eacute;rin-treated, non-muscle-invasive bladder cancer

Holz, Serge; Albisinni, Simone; Gilsoul, Jacques; Pirson, Michael; Duthie, Véronique; Quackels, Thierry; Bossche, Marc Vanden; Roumeguère, Thierry

doi:10.2147/rru.s143865

Cited by 8 publications

(17 citation statements)

References 23 publications

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“…Evaluation of smoking habits was based on hospital records. In our present study, the percentage of never smokers was similar to patients treated with BCG instillation described elsewhere . The reported total number of eight BCG instillations does not take into account whether the patients completed their first series of six BCG instillations, had maintenance therapy or a second series of instillations.…”

Section: Discussionsupporting

confidence: 75%

The epidemiology of bacille Calmette–Guérin infections after bladder instillation from 2002 through 2017: a nationwide retrospective cohort study

et al. 2019

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ObjectiveTo describe incidence and clinical characteristics of bacille Calmette-Gu erin (BCG) infections after BCG bladder instillation amongst patients with non-muscle-invasive bladder cancer in Denmark. Patients and methodsWe conducted a nationwide register-based cohort study in Denmark between 2002 through 2017. Patients with BCG infection were identified by cross-linking data from the Danish National Hospital Registry on patients treated with BCG instillations and patients diagnosed with tuberculosis according to the International Classification of Diseases 10, and data obtained from International Reference Laboratory of Mycobacteriology. Hospital records were reviewed for clinical information. ResultsDuring the study period, 6753 patients (5281 men; mean [SD] age 71.1 (0.1) years) received BCG instillations, of which 66 patients (1%) developed BCG infections. There were no differences in age or Charlson Comorbidity Index between the patients in the study population stratified by BCG infection. The median (interquartile range) time from first BCG instillation until symptoms of BCG infection was 169.5 (38-585) days. Extrapulmonary localisation of BCG infections (37 patients, 56.1%) was significantly more frequent than pulmonary BCG infections (20 patients, 30.3%; P < 0.001). The most common extrapulmonary localisation was the genitourinary tract (29 patients, 78.4%). ConclusionBCG infections after bladder instillation are rare, mainly affect male patients, and are most frequently extrapulmonary. BCG infections should be suspected despite a long time span between occurrence of symptoms and prior bladder instillation.

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Section: Discussionsupporting

confidence: 75%

The epidemiology of bacille Calmette–Guérin infections after bladder instillation from 2002 through 2017: a nationwide retrospective cohort study

et al. 2019

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“…Most MIBCs arise from carcinoma in situ (CIS), a flat, high-grade, superficial urothelial lesion that is characterized by TP53 mutations and accounts for approximately 10% of all diagnosed bladder tumors [ 3 ]. CIS is considered to be an obligate precancerous lesion, while concomitant CIS is associated with a markedly worse prognosis in patients with bladder cancer, a fact that is mirrored in multiple clinical risk scores (Spanish Urological Club for Oncological Treatment (CUETO), European Organization for Research and Treatment of Cancer (EORTC)) [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Progression of urothelial carcinoma in situ of the urinary bladder: a switch from luminal to basal phenotype and related therapeutic implications

Barth

Schneider

Grimm³

et al. 2018

Virchows Arch

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The stratification of bladder cancer into luminal and basal tumors has recently been introduced as a novel prognostic system in patient cohorts of muscle-invasive bladder cancer or high-grade papillary carcinomas. Using a representative immunohistochemistry panel, we analyzed luminal and basal marker expression in a large case series (n = 156) of urothelial carcinoma in situ (CIS), a precancerous lesion that frequently progresses to muscle-invasive disease. The majority of CIS cases was characterized by a positivity for luminal markers (aberrant cytokeratin (CK) 20 85% (132/156), GATA3 median Remmele score (score of staining intensity (0–3) multiplied with percentage of positive cells (0–4)): 12, estrogen receptor (ER) β Remmele score > 2: 88% (138/156), human epidermal growth factor receptor 2 (Her2) Dako score 3+ 32% (50/156), Her2 Dako score 2+ 33% (51/156)), and marginal expression of basal markers (CK5/6+ 2% (3/156), CK14+ 1% (2/156)). To further investigate phenotypic stability during disease progression, we compared 48 pairs of CIS and invasive tumors from the same biopsy. A highly significant loss of luminal marker expression (p < 0.001) was observed in the course of progression whereas an increase of basal marker expression (p < 0.01) was noted in the invasive compartment. Importantly, 91% of CIS cases demonstrated a positivity for at least one of the two predictive markers Her2 and ERβ, indicating that the analysis of Her2 and ERβ may help to identify CIS-patient subgroups prone to more efficient targeted treatment strategies. Larger prospective and biomarker-embedded clinical trials are needed to confirm and validate our preliminary findings.Electronic supplementary materialThe online version of this article (10.1007/s00428-018-2354-9) contains supplementary material, which is available to authorized users.

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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%

“…20,45,47,52,59,63,77,78 The use of maintenance BCG in HR-NMIBC was reported in 31 studies, with rates being more variable than those seen with induction therapy. 16,17,[26][27][28][29]31,33,34,36,37,40,42,45,46,[49][50][51][52]54,56,59,61,63,65,68,69,72,74,75,77 Only 7 studies (23%) reported BCG maintenance being used in all high-risk patients (100%). 26,28,29,40,49,56,61 Among the remaining 24 studies, use of maintenance BCG therapy ranged between 8-83%.…”

Section: Treatment Patternsmentioning

confidence: 99%

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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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Risk factor assessment in high-risk, bacillus Calmette–Guérin-treated, non-muscle-invasive bladder cancer

Cited by 8 publications

References 23 publications

The epidemiology of bacille Calmette–Guérin infections after bladder instillation from 2002 through 2017: a nationwide retrospective cohort study

The epidemiology of bacille Calmette–Guérin infections after bladder instillation from 2002 through 2017: a nationwide retrospective cohort study

Progression of urothelial carcinoma in situ of the urinary bladder: a switch from luminal to basal phenotype and related therapeutic implications

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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