Randomized Controlled Study of the Efficacy, Safety and Quality of Life with Low Dose bacillus Calmette-Guérin Instillation Therapy for Nonmuscle Invasive Bladder Cancer

Yokomizo, Akira; Kanimoto, Yusuke; Okamura, Takehiko; Ozono, Seiichiro; Koga, Hirofumi; Iwamura, Masatsugu; Tanaka, Hiroshi; Takahashi, Satoru; Tsushima, Tomoyasu; Kanayama, Hiro Omi; Akaza, Hideyuki; Shinohara, Nobuo; Mugiya, Soichi; Nomata, Koichiro; Nakamura, Tsuyoshi; Naito, Seiji

doi:10.1016/j.juro.2015.08.075

Cited by 56 publications

(49 citation statements)

References 14 publications

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“…In support to our data, the use of one-half or one-third of BCG for standard instillation has recently been proposed. A study in NMIBC-patients treated with low dose BCG had lower toxicity and higher quality of life compared with NMIBC-patients instilled with standard-dose [57, 58]. Thus, low dose BCG can be applied to different BCG research fields of interest including mycobacterial infections, cancer immunotherapy, and prevention of autoimmunity and allergies [59].…”

Section: Discussionmentioning

confidence: 99%

Low Dose BCG Infection as a Model for Macrophage Activation Maintaining Cell Viability

Chávez‐Galán

Vesin

Martinvalet

et al. 2016

Journal of Immunology Research

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Mycobacterium bovis BCG, the current vaccine against tuberculosis, is ingested by macrophages promoting the development of effector functions including cell death and microbicidal mechanisms. Despite accumulating reports on M. tuberculosis, mechanisms of BCG/macrophage interaction remain relatively undefined. In vivo, few bacilli are sufficient to establish a mycobacterial infection; however, in vitro studies systematically use high mycobacterium doses. In this study, we analyze macrophage/BCG interactions and microenvironment upon infection with low BCG doses and propose an in vitro model to study cell activation without affecting viability. We show that RAW macrophages infected with BCG at MOI 1 activated higher and sustained levels of proinflammatory cytokines and transcription factors while MOI 0.1 was more efficient for early stimulation of IL-1β, MCP-1, and KC. Both BCG infection doses induced iNOS and NO in a dose-dependent manner and maintained nuclear and mitochondrial structures. Microenvironment generated by MOI 1 induced macrophage proliferation but not MOI 0.1 infection. In conclusion, BCG infection at low dose is an efficient in vitro model to study macrophage/BCG interactions that maintains macrophage viability and mitochondrial structures. This represents a novel model that can be applied to BCG research fields including mycobacterial infections, cancer immunotherapy, and prevention of autoimmunity and allergies.

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Section: Discussionmentioning

confidence: 99%

Low Dose BCG Infection as a Model for Macrophage Activation Maintaining Cell Viability

Chávez‐Galán

Vesin

Martinvalet

et al. 2016

Journal of Immunology Research

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“…The studies included were heterogeneous with sample sizes of between 30-244 patients. Six studies compared HRQoL of patients after treatment with different adjuvant intravesical chemotherapy protocols, suggesting that intravesical instillation affects overall HRQoL [19][20][21][22][23][24]. Three studies focussed on sexual HRQoL of patients with NMIBC and reported a high prevalence of sexual dysfunction in this patient cohort [21,25,26].…”

Section: Discussionmentioning

confidence: 99%

“…Overall, patients with NMIBC appeared to be coping well following a diagnosis of NMIBC with a median (IQR) Brief-IPQ score of 32 (22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40). At 6 months after a diagnosis of NMIBC, patients reported that the disease had a minimal effect on their life (Q1) (median [IQR] score 2 [0-5]).…”

Section: Brief-ipq Scorementioning

confidence: 99%

Exploring patients’ experience and perception of being diagnosed with bladder cancer: a mixed‐methods approach

et al. 2020

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ObjectiveTo determine patient experience and perception following a diagnosis of non-muscle-invasive bladder cancer (NMIBC). Patient and methodsPatients were part of a prospective multicentre observational study recruiting patients with NMIBC for a urine biomarker study (DETECT II; ClinicalTrials.gov: NCT02781428). A mixed-methods approach comprising: (i) the Brief Illness Perception Questionnaire (Brief-IPQ) and (ii) semi-structured interviews to explore patients' experience of having haematuria, and initial and subsequent experience with a NMIBC diagnosis. Both assessments were completed at 6 months after NMIBC diagnosis. ResultsA total of 213 patients completed the Brief-IPQ. Patients felt that they had minimal symptoms (median [interquartile range, IQR] score 2 [0-5]) and were not particularly affected emotionally (median [IQR] score 3 [1-6]) with a minimal effect to their daily life (median [IQR] score 2 [0-5]). However, they remained concerned about their cancer diagnosis (median [IQR] score 5 [3-8]) and felt that they had no personal control over the cancer (median [IQR] score 2 [2-5]) and believed that their illness would affect them for some time (median [IQR] score 6 [3-10]). A significant association with a lower personal control of the disease (P < 0.05) and a poorer understanding of the management of NMIBC (P < 0.05) was seen in patients aged >70 years. Many patients were uncertain about the cause of bladder cancer. Qualitative analysis found that at initial presentation of haematuria, most patients were not aware of the risk of bladder cancer. Patients were most anxious and psychologically affected between the interval of cystoscopy diagnosis and transurethral resection of bladder tumour (TURBT). Following TURBT, most patients were positive about their cancer prognosis.

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“…BCG vaccine also has been shown to have a predilection for entering bladder cancer cells, where the proteins are broken down and fragments are combined with antigens and displayed on the cell surface. This induces a cytokine and direct cell-to-cell cytotoxicity response, which targets tumor cells for destruction 5 .…”

Section: Mechanism Of Action Of Bcgmentioning

confidence: 99%

BCG Immunotherapy for Bladder Carcinoma

Mallik¹,

Rahman²,

Halder³

2017

KYAMC j.

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Purpose: We reviewed the literatures to see history, regimen of BCG and how BCG become a standard therapy for bladder carcinoma.Materials and Methods: We reviewed the previous literature describing the bacillus Calmette-Guerin (BCG) vaccine as an anticancer agent and its success as the most effective immunotherapy used against human bladder cancer and its adverse effects.Results: The association between tuberculosis and carcinoma is well established, It demonstrate that Bacillus Calmette-Guerin have immunological reactivity, inhibiting the tumor growth and progression in experimental animal models, led to clinical trials showing that intravesical Bacillus Calmette-Guerin eradicate and prevent recurrence and progression of superficial bladder carcinoma The exact mechanism of action of intravesical BCG instillation is still under investigation. However, it appears that BCG is mediated by the local immune response, mainly through T-helper cell response. It reduces the recurrence rate by an average of 40% and progression by more than 20% in papillary tumors, Carcinoma-in-situ over the patients without BCG therapy.Conclusions: For the last 45 yrs Bacillus Calmette- Guerin therapy has remained first line intravesical immunotherapy for superficial bladder cancer, an outstanding example of successful immunotherapy.KYAMC Journal Vol. 8, No.-1, Jul 2017, Page 56-60

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Randomized Controlled Study of the Efficacy, Safety and Quality of Life with Low Dose bacillus Calmette-Guérin Instillation Therapy for Nonmuscle Invasive Bladder Cancer

Abstract: The noninferiority of low dose bacillus Calmette-Guérin was not proven. However, low dose bacillus Calmette-Guérin was associated with lower toxicity and higher quality of life compared to standard dose bacillus Calmette-Guérin in patients with nonmuscle invasive bladder cancer.

Cited by 56 publications

References 14 publications

Low Dose BCG Infection as a Model for Macrophage Activation Maintaining Cell Viability

Low Dose BCG Infection as a Model for Macrophage Activation Maintaining Cell Viability

Exploring patients’ experience and perception of being diagnosed with bladder cancer: a mixed‐methods approach

BCG Immunotherapy for Bladder Carcinoma

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