Incidence and Treatment of Complications of Bacillus Calmette-Guerin Intravesical Therapy in Superficial Bladder Cancer

Lamm, Donald L.; Meijden, A.P.M. van der; Morales, Álvaro; Brosman, Stanley A.; Catàlona, William J.; Herr, Harry W.; Soloway, Mark S.; Steg, A; Debruyne, F.M.J.

doi:10.1016/s0022-5347(17)37316-0

Cited by 671 publications

(542 citation statements)

References 14 publications

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“…Although this form of treatment is an effective therapy, serious side-effects associated with the use of live mycobacteria, such as the development of systemic BCG infections, sepsis and even death, pose a significant concern [5]. In clinical studies, the incidence rate of subjective and/or objective symptoms was 78.3% [3,4].…”

Section: Introductionmentioning

confidence: 99%

Nanoparticulation of BCG-CWS for application to bladder cancer therapy

Nakamura

Fukiage

Higuchi

et al. 2014

Journal of Controlled Release

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The Mycobacterium bovis Bacille Calmett-Guerin cell wall skeleton (BCG-CWS) could be used to replace live BCG as a bladder cancer drug. However, because BCG-CWS is poorly soluble, has a strong-negative charge, very high molecular weight and heterogeneity in size of tens of μm, it cannot be used in such an application. We report herein on the development of a novel packaging method that permits BCG-CWS to be encapsulated into 166 nm-sized lipid particles. The BCG-CWS encapsulated nano particle (CWS-NP) has a high uniformity and can be easily dispersed. Thus, it has the potential for use as a packaging method that would advance the scope of applications of BCG-CWS as a bladder cancer drug. In a functional evaluation, CWS-NP was efficiently taken up by mouse bladder tumor cells (MBT-2) in vitro and inhibited tumor growth in mice bearing MBT-2 tumors. Moreover, intravesically administered CWS-NP showed significant antitumor effects in a rat model with in naturally developed bladder cancer. An enhancement in Th1 differentiation by CWS-NP was also confirmed in human T cells. In conclusion, CWS-NP represents a promising delivery system for BCG-CWS for clinical development as a potent bladder cancer drug.

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Section: Introductionmentioning

confidence: 99%

Nanoparticulation of BCG-CWS for application to bladder cancer therapy

Nakamura

Fukiage

Higuchi

et al. 2014

Journal of Controlled Release

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“…Although local side-effects of BCG immunotherapy are usually self-limited, severe systemic reaction and even life-threatening toxicity can occur. 1,2 We report here the first case of acute eosinophilic pneumonia following intravesical BCG.…”

Section: Introductionmentioning

confidence: 88%

Acute eosinophilic pneumonia associated with intravesical bacillus Calmette‐Guérin therapy of carcinoma in situ of the bladder

Orikasa

Namima²,

Ōta

et al. 2003

Int J of Urology

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A 71-year-old man with a history of rheumatoid arthritis was treated with intravesical bacillus Calmette-Guérin (BCG) instillation of 80 mg once-a-week for carcinoma in situ . He developed lowgrade fever followed by dyspnea and severe hypoxemia. Radiological and laboratory studies revealed bilateral diffuse reticulonodular infiltrates and hypereosinophilia. A lymphocyte stimulation test for BCG was strongly positive. From these findings, a pulmonary hypersensitivity reaction to immunotherapy was suspected, and therefore, methylprednisolone (500 mg per day) was started. After that, the fever and dyspnea disappeared, the hypereosinophilia was normalised and chest radiography results were clear. The present case is the first reported case of eosinophilic pneumonia following intravesical BCG therapy.

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“…Another rare but serious complication resulting from systemic exposure to BCG is sepsis that can in some cases lead to death. 3 Although BCG following transurethral resection of the bladder tumor is an effective treatment, other options are needed, given the toxicities, the number of patients who are unable to complete treatment (20%) and the number of patients who fail treatment or have recurrent disease within 5 years (30%). 4 Recombinant interferon alfa-2b (INTRON A) has pleiotropic effects that contribute to antitumor activity such as antiproliferative, apoptosis, angiogenesis inhibition, and immune augmentation.…”

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

Toxicity and exposure of an adenovirus containing human interferon alpha-2b following intracystic administration in cynomolgus monkeys

Nelson³

et al. 2011

Gene Ther

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The safety and toxicokinetics of SCH 721015, an adenovirus encoding the human interferon alpha-2b gene, and Syn3 (SCH 209702), a novel excipient, were assessed in cynomolgus monkeys administered intravesical doses of 2.5Â10E11 or 1.25Â10E13 particles SCH 721015 in 25 mg Syn3 or 25 mg Syn3 alone on study days 1 and 91. There was no systemic toxicity. Monkeys dosed with SCH 721015 in Syn3 were positive for SCH 721015-specific DNA in the urine for 2 to 3 days following each dose and had interferon alpha-2b protein in the urine for 1-3 days after a single dose and in fewer animals after a second dose. Intracystic administration was associated with inflammation and focal/multifocal ulceration in the urinary bladder and irritation in the ureters and urethra at necropsy. The physical trauma from catheterization and filling/emptying of the bladder was likely a contributing factor and Syn3 exacerbated the trauma. There was nearly complete resolution of these findings 2 months after the last dose. The trauma to the bladder likely contributed to low, transient systemic exposure to Syn3, SCH 721015 and human interferon protein. Keywords: adenovirus; interferon alpha-2b; monkey; bladder; intracystic; intravesical INTRODUCTIONThe American Cancer Society estimated that the incidence of new cases and deaths of urinary bladder cancer were 70 530 and 14 680, respectively, in 2010. 1 Superficial (or non-muscle invasive) bladder cancer can be treated with a transurethral resection of the bladder tumor via a cystoscope, often followed by intracystic (within the bladder) treatment with an adjuvant, immunotherapy or chemotherapy to reduce recurrence. The type of intracystic therapy depends on many factors but Bacillus Calmette-Guerin (BCG) immunotherapy has been the most common. BCG is a live attenuated strain of Mycobacterium tuberculosis that is instilled in the bladder for 1 to 2 h at a cycle of once weekly for 6 weeks, sometimes followed by an additional cycle and/or a maintenance schedule for up to a year. The mechanism of action for BCG involves a complex immunological reaction but is not fully known. 2 Transurethral resection of the bladder tumor followed by BCG is the most efficacious treatment option, but BCG treatment is associated with high toxicity. The side effects include lower urinary tract symptoms (for example, pain with urination), fever and flu-like symptoms, hematuria, skin rash, bladder contracture and urogenital-related infections, with B5% of patients treated with the standard dose (120 mg) experiencing moderate or severe side effects. Another rare but serious complication resulting from systemic exposure to BCG is sepsis that can in some cases lead to death. 3 Although BCG following transurethral resection of the bladder tumor is an effective treatment, other options are needed, given the toxicities,

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Incidence and Treatment of Complications of Bacillus Calmette-Guerin Intravesical Therapy in Superficial Bladder Cancer

Cited by 671 publications

References 14 publications

Nanoparticulation of BCG-CWS for application to bladder cancer therapy

Nanoparticulation of BCG-CWS for application to bladder cancer therapy

Acute eosinophilic pneumonia associated with intravesical bacillus Calmette‐Guérin therapy of carcinoma in situ of the bladder

Toxicity and exposure of an adenovirus containing human interferon alpha-2b following intracystic administration in cynomolgus monkeys

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