Side Effects of Bacillus Calmette-Guérin (BCG) in the Treatment of Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Bladder: Results of the EORTC Genito-Urinary Cancers Group Randomised Phase 3 Study Comparing One-third Dose with Full Dose and 1 Year with 3 Years of Maintenance BCG

Brausi, Maurizio; Oddens, Jorg R.; Sylvester, Richard; Bono, Aldo; Beek, C. van de; Andel, George van; Gontero, Paolo; Türkeri, Levent; Marréaud, Sandrine; Collette, Sandra; Oosterlinck, Willem

doi:10.1016/j.eururo.2013.07.021

Cited by 281 publications

(227 citation statements)

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“…12 However, the side effects of BCG are remarkable, and the treatment discontinuation rate of BCG for toxicity is 7% to 19%. 13 In a meta-analysis, a 32% reduction in tumour recurrence for BCG maintenance compared to MMC was found. 4 MMC should be considered a less effective alternative treatment for patients intolerant to BCG.…”

Section: Discussionmentioning

confidence: 99%

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Ekin¹,

Akarken

Zorlu³

et al. 2015

CUAJ

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Introduction: Patients with high-risk non-muscle invasive bladder cancer (NMIBC) need adjuvant intravesical treatment after surgery. Although bacillus Calmette-Guérin (BCG) is highly effective, new adjuvant treatments to decrease recurrences and toxicity have been studies. We performed a retrospective propensity score-matched study to compare the efficacy of BCG and chemohyperthermia (C-HT). Methods: We included 1937 patients diagnosed with bladder cancer between January 2004 and January 2014. The primary efficacy endpoint was recurrence-free interval. Patients treated with C-HT were matched with patients treated with BCG using propensity score-matched analysis. Cox-regression models were used to estimate the association between intravesical treatments and the presence of recurrence and progression. Results: Of the 710 patients treated with intravesical treatments, 40 and 142 were eligible for inclusion in C-HT and BCG groups, respectively. Following case matching, there were no differences in patient or tumour characteristics between treatment groups. The 2-year recurrence-free interval in C-HT and BCG groups were 76.2% and 93.9%, respectively (p = 0.020). C-HT treatment (hazard ratio [HR] 5.42; 95% confidence interval [CI] 1.11-26.43; p = 0.036) and high-grade tumour (HR 4.60; 95% CI 1.01-20.88; p = 0.048) are associated with an elevated odds of tumour recurrence. In multivariate Cox-regression analysis, there was no significant difference between C-HT and BCG in the odds of recurrence (p = 0.054). There were no differences in progression between C-HT and BCG. Conclusion: C-HT is not as effective treatment as BCG in high-risk NMIBC patients who are BCG-naive. Although, there were no significant difference in the odds of recurrence, recurrence-free interval is significantly improved by the administration of BCG.

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Section: Discussionmentioning

confidence: 99%

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Ekin¹,

Akarken

Zorlu³

et al. 2015

CUAJ

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“…Se han comunicado casos excepcionales de infecciones diseminadas por M. bovis en pacientes con cáncer de vejiga luego de la inmunoterapia intravesical con BCG (13)(14)(15)(16)(17)(18)(19)(20) y se estimó una mortalidad 1/12.500 pacientes tratados (13) . El estudio EORTC, con más de 1.300 pacientes incluidos, puso en evidencia que en el 63% de los que iniciaron tratamiento con BCG intravesical se detectaron efectos secundarios locales y 31% presentó algún tipo de efecto secundario sistémico, a partir de un corto período frecuente de fiebre y malestar general (21,22) . Los efectos secundarios locales más frecuentes en el estudio fueron cistitis inducida por BCG (35%), infección bacteriana (23%) y hematuria macroscópica en 23%.…”

Section: Discusión Y Comentariosunclassified

“…La sepsis por BCG fue un episodio raro, observándose solamente en cuatro pacientes (0,3%). La frecuencia fue similar en la inducción (primeras seis instilaciones) como durante el primer y los dos años siguientes (21) . La discontinuación del tratamiento por efectos secundarios graves se produjo entre el 8% y el 19% de los casos (21,22) .…”

Section: Discusión Y Comentariosunclassified

“…La frecuencia fue similar en la inducción (primeras seis instilaciones) como durante el primer y los dos años siguientes (21) . La discontinuación del tratamiento por efectos secundarios graves se produjo entre el 8% y el 19% de los casos (21,22) . La mayoría de las interrupciones (75%) sucedieron en el primer año de tratamiento y su frecuencia ha disminuido en los estudios más recientes (21) .…”

Section: Discusión Y Comentariosunclassified

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Impacto de la ley uruguaya de seguridad vial en la mortalidad por siniestros de tránsito

Vanerio

Trostchansky

Machado

et al. 2018

RMU

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La instilación intravesical de bacilo de Calmette-Guérin (BCG) es el tratamiento de primera línea para el carcinoma superficial de células transicionales de la vejiga. Aunque su uso es relativamente seguro, complicaciones graves como hepatitis granulomatosa, osteomielitis, neumonía, sepsis y disfunción orgánica múltiple se producen en algunos pacientes. Presentamos el caso de un paciente con diagnósti-co de carcinoma de células de transición superficial de la vejiga (T1), que fallece como consecuencia de una complicación sistémica grave con severo compromiso del sistema nervioso central, secundaria a la instilación intravesical de BCG. Palabras clave: BACILO DE CALMETTE-GUÉRIN IntroducciónLa resección transuretral puede erradicar completamente determinados tumores de vejiga, aunque la incidencia de recurrencia es relativamente elevada (48% a 70%)(1) . La terapia adyuvante intravesical con una solución de bacilo de Calmette-Guérin (BCG) ha demostrado su efectividad y está incluida en guías de práctica clíni-ca (2,3) . La vacuna contra el BCG, una cepa viva atenuada de Mycobacterium bovis, fue introducida por primera vez en humanos en 1921 (4) . La instilación intravesical de BCG fue descrita por primera vez en 1976 por Morales (5) y se utiliza para el tratamiento del carcinoma de células transicionales superficial de la vejiga. El efecto antitumoral parece ser mediado por inmunidad celular dependiente de los linfocitos T; sin embargo, su modo preciso de acción no es completamente conocido (6) . Esta terapia ha demostrado ser eficaz en retrasar la recurrencia después de la resección transuretral, en reducir el riesgo de progresión a la enfermedad invasiva del músculo, en la erradicación de tumores residuales en algunos pacientes con carcinoma papilar y carcinoma in situ y en mejorar la supervivencia (2,7) . Como contrapartida, puede estar asociada a efectos secundarios importantes. Una complicación poco frecuente pero grave de esta terapia inmunológica es el desarrollo de la enfermedad diseminada por BCG que se puede manifestar por neumonitis, infecciones graves de piel y tejidos blandos, infección genito-urinaria (prostatitis y orqui-1

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“…An important suggestion is to give written information to patients and their guardians on the possible severe early and late complications in any organ of the body. Although it has not been proved, it seems a method of common sense to improve early detection and therapy 26 . When BCG vaccine therapy was introduced, several deaths were reported, all of which could be attributed to improper use of this agent.…”

Section: Side Effects 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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Side Effects of Bacillus Calmette-Guérin (BCG) in the Treatment of Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Bladder: Results of the EORTC Genito-Urinary Cancers Group Randomised Phase 3 Study Comparing One-third Dose with Full Dose and 1 Year with 3 Years of Maintenance BCG

Cited by 281 publications

References 20 publications

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Impacto de la ley uruguaya de seguridad vial en la mortalidad por siniestros de tránsito

BCG Immunotherapy for Bladder Carcinoma

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