Author: Joosten, Leo A B ; Zuiverloon, Tahlita C M ; Aben, Katja K H ; Witjes, J Alfred ; Novakovic, Boris ; Kiemeney, Lambertus A L M ; Vermeulen, Sita H ; Galesloot, Tessel E ; van Puffelen, Jelmer H ; van Emst, Liesbeth ; Oosterwijk, Egbert ; Oldenhof, Ursula T H ; Boormans, Joost L ; Netea, Mihai G ; Vrieling, Alina ; Kooper, Denise ; van der Heijden, Antoine G

BackgroundBCG is recommended as intravesical immunotherapy to reduce the risk of tumor recurrence in patients with non-muscle invasive bladder cancer (NMIBC). Currently, it is unknown whether intravesical BCG application induces trained immunity.MethodsThe aim of this research was to determine whether BCG immunotherapy induces trained immunity in NMIBC patients. We conducted a prospective observational cohort study in 17 NMIBC patients scheduled for BCG therapy and measured trained immunity parameters at 9 time points before and during a 1-year BCG maintenance regimen. Ex vivo cytokine production by peripheral blood mononuclear cells, epigenetic modifications, and changes in the monocyte transcriptome were measured. The frequency of respiratory infections was investigated in two larger cohorts of BCG-treated and non-BCG treated NMIBC patients as a surrogate measurement of trained immunity. Gene-based association analysis of genetic variants in candidate trained immunity genes and their association with recurrence-free survival and progression-free survival after BCG therapy was performed to investigate the hypothesized link between trained immunity and clinical response.ResultsWe found that intravesical BCG does induce trained immunity based on an increased production of TNF and IL-1β after heterologous ex vivo stimulation of circulating monocytes 6–12 weeks after intravesical BCG treatment; and a 37% decreased risk (OR 0.63 (95% CI 0.40 to 1.01)) for respiratory infections in BCG-treated versus non-BCG-treated NMIBC patients. An epigenomics approach combining chromatin immuno precipitation-sequencing and RNA-sequencing with in vitro trained immunity experiments identified enhanced inflammasome activity in BCG-treated individuals. Finally, germline variation in genes that affect trained immunity was associated with recurrence and progression after BCG therapy in NMIBC.ConclusionWe conclude that BCG immunotherapy induces trained immunity in NMIBC patients and this may account for the protective effects against respiratory infections. The data of our gene-based association analysis suggest that a link between trained immunity and oncological outcome may exist. Future studies should further investigate how trained immunity affects the antitumor immune responses in BCG-treated NMIBC patients

01 Oct 2022·Alzheimer Disease & Associated Disorders

Results From an Administrative Dataset

Article

Author: Gore, John L. ; Holt, Sarah K. ; Makrakis, Dimitrios ; Grivas, Petros ; Wright, Jonathan L. ; Bernick, Charles

Introduction:Alzheimer disease (AD) is a common neurodegenerative disease, and immunomodulation offers treatment opportunities. Preclinical data suggest that intravesical Bacillus Calmette-Guerin (BCG) treatment could delay AD development. We investigated this relationship in a population-based cancer database.Sample and Methods:We queried the Surveillance, Epidemiology, and End Results-Medicare database for patients with high-risk nonmuscle-invasive bladder cancer (hrNMIBC). BCG dosage and subsequent Alzheimer diagnosis were collected through ICD-9/10 codes. Multivariable Cox regression was performed to assess the association between BCG therapy and subsequent Alzheimer diagnosis.Results:We identified 26,584 hrNMIBC patients; 51% received BCG and 8.3% were diagnosed with Alzheimer. BCG exposure was significantly associated with lower Alzheimer occurrence (hazard ratio: 0.73, P<0.05), which was dose-dependent. Increasing age, female sex, Black race, and increasing comorbidity index were significantly associated with a greater risk of subsequent Alzheimer diagnosis.Discussion:Treatment with intravesical BCG among patients with hrNMIBC was associated with a significantly lower risk for subsequent Alzheimer diagnosis, which seemed dose-dependent.

01 Mar 2021·UrologyQ3 · MEDICINE

Side Effects of Intravesical BCG and Chemotherapy for Bladder Cancer: What They Are and How to Manage Them

Q3 · MEDICINE

Review

Author: Smelser, Woodson W ; Koch, George E ; Chang, Sam S

Intravesical therapy for nonmuscle invasive bladder cancer decreases recurrence and progression but carries a high risk of side effects, which limit patient adherence. Appropriate management of the toxicities from intravesical therapy requires consideration of the agent used, the side effects experienced, and the timing of those side effects. Management strategies for intravesical toxicities ideally improve patient tolerance without sacrificing oncologic outcomes. This review aims to provide a comprehensive overview of the available evidence regarding the side effects of intravesical therapies for nonmuscle invasive bladder cancer and to propose practical strategies for toxicity management.

100 Deals associated with BCG for Intravesical Instillation(China Medical System)

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Indication	Country/Location	Organization	Date
Urothelial Carcinoma of the Urinary Bladder	DE	medac Gesellschaft für klinische Spezialpräparate mbH	02 Oct 2001
Bladder Cancer	-	Shenzhen Kangzhe Pharmaceutical Co., Ltd.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2023	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	40	intravesical Bacillus Calmette-Guérin instillation (TERT C228T mutation)	(tfhkuskcli) = qlybvpxbfh oprzuwuilv (zyrfgsqlnd )	-	04 Apr 2023
				intravesical Bacillus Calmette-Guérin instillation (KDM6A alteration)	(tfhkuskcli) = rebchnrwgw oprzuwuilv (zyrfgsqlnd )
ESMO_ASIA2022	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	140	Intravesical Chemohyperthermia with Mitomycin C	(erqwmpjtqc) = ydzskjbofd pajpddjqiv (mgzpmiclrv )	Positive	02 Dec 2022
				Intravesical BCG Immunotherapy	(erqwmpjtqc) = xdxdpsgfsd pajpddjqiv (mgzpmiclrv ) View more
MP82-18 (AUA2020)	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	1,128	INTRAVESICAL BCG INSTILLATION (BCG instillation)	nfwcrxgdce(mthbnspiax) = lbpefogvav xulziuuslq (lvkxwlmyjz ) View more	-	01 Apr 2020
AUA2016	Not Applicable	Non-Muscle Invasive Bladder Neoplasms Adjuvant	96	Intravesical instillation of BCG plus 2 gm of tranexamic acid	(awtpqjqvqm) = ysugpykyga uaupfwmrup (tnjiewpqhk ) View more	Positive	01 Apr 2016
				Intravesical instillation of BCG alone	(awtpqjqvqm) = efqgpsscfc uaupfwmrup (tnjiewpqhk ) View more
PD10-09 (AUA2015)	Not Applicable	Urinary Bladder, Neurogenic	50	Gentamicin intravesical instillations	oiopcnvtni(igfjmdbtdk) = vpdysatvyy xrtfbvlzqg (omevocvflv )	-	01 Apr 2015
536 (AUA2012)	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma	72	Intravesical instillation of pyrarubicin (THP)	jzizsoqvfc(kczoirxvkb) = tumzdrhrjc ivftijtbjq (bxxcgsodyb )	-	01 Apr 2012
				PIRARUBICIN (No instillation)	jzizsoqvfc(kczoirxvkb) = nkmvztakqf ivftijtbjq (bxxcgsodyb )

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