BCG shortage for intravesical instillation is associated with early tumoral recurrence in patients with high-risk non-muscle invasive bladder tumours

BCG shortage for intravesical instillation is associated with early tumoral recurrence in patients with high-risk non-muscle invasive bladder tumours

During 2019 there was a worldwide shortage of BCG strains for intravesical instillation, limiting the availability of full dose schemes for maintenance courses. The main objective was to analyze the impact on tumoral relapse secondary to BCG shortage in our center. Secondary outcomes included recurr...

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Bibliographic Details
Published in:Actas urológicas españolas (English ed.) Vol. 47; no. 4; pp. 250 - 258
Main Authors: Pérez-Aizpurua, X., Monzó-Gardiner, J.I., Maqueda-Arellano, J., Buendía-González, E., Cuello-Sánchez, L., Tufet i Jaumot, J.J., Alonso-Román, J., Gómez-Jordana Mañas, B., Ruiz de Castroviejo Blanco, J., Osorio Ospina, F., Cabello Benavente, R., González-Enguita, C.
Format: Journal Article
Language:English
Published: Spain Elsevier España, S.L.U 01-05-2023
Subjects:
Administration, Intravesical
Bacilo de Calmette-Guerin
BCG shortage
BCG Vaccine - therapeutic use
Calmette–Guerin bacillus
Cáncer de vejiga no músculo invasivo
Escasez de BCG
Humans
Instilación(es) intravesical(es)
Intravesical instillation(s)
Non-muscle invasive bladder cancer
Recurrence
Retrospective Studies
Urinary Bladder
Urinary Bladder Neoplasms - drug therapy
Urinary Bladder Neoplasms - pathology
Urinary Bladder Neoplasms - surgery
Non-muscle invasive bladder cancer
BCG shortage
Instilación(es) intravesical(es)
Cáncer de vejiga no músculo invasivo
Calmette–Guerin bacillus
Bacilo de Calmette-Guerin
Escasez de BCG
Intravesical instillation(s)
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Summary:During 2019 there was a worldwide shortage of BCG strains for intravesical instillation, limiting the availability of full dose schemes for maintenance courses. The main objective was to analyze the impact on tumoral relapse secondary to BCG shortage in our center. Secondary outcomes included recurrence and progression–free survival rates and tumoral relapse specific characteristics. Retrospective cohort study including 158 subjects (64 treated during 2019 and 94 during 2017) with high-risk non-muscle invasive bladder cancer and treated with a combination of Transurethral bladder resection (TURB) followed by adjuvant intravesical instillation with BCG in a tertiary hospital in Spain. Basal characteristics of both groups were analyzed. Times to event of interest (relapse; including recurrence and/or progression) were estimated with Kaplan–Meier survival analysis. Disease-free survival rates were analyzed using a multivariable Cox regression model of proportional hazards. Median follow-up in the 2019 sample was 24 months and 50 months in the 2017 group with a median number of instillations of 8 and 12 respectively. Median time to relapse of 285 days (145–448) during 2019 and 382 days (215–567) in 2017 were observed (logRank p = 0.025). Further multivariable analysis revealed a proportional hazard ratio (HR) for disease-free survival rate of 1.87 (95% CI: 1.04–3.37 p = 0.036). No statistically significant differences in tumoral relapse characteristics were observed. BCG shortage and subsequent reduced-dose schemes used for intravesical instillation due to limited availability, increase early tumoral relapse rates. These findings are consistent with available evidence, showing the need for full-dose BCG courses. Durante 2019 se produjo una escasez mundial de cepas de BCG para instilación intravesical, limitando la disponibilidad de esquemas de dosis completas para la fase de mantenimiento. El objetivo principal del estudio fue analizar el impacto del desabastecimiento de BCG sobre la recidiva tumoral en nuestro centro. Los criterios de valoración secundarios incluyeron las tasas de recidiva y supervivencia libre de progresión y las características específicas de la recidiva tumoral. Estudio de cohortes retrospectivo que incluye a 158 sujetos (64 tratados durante 2019 y 94 durante 2017) con cáncer vesical no infiltrante de alto riesgo y tratados con una combinación de resección transuretral de vejiga (RTUV) seguida de instilación intravesical de BCG adyuvante en un hospital terciario de España. Se analizaron las características basales de ambos grupos. El periodo transcurrido hasta el evento de interés (recaída; incluyendo recurrencia o progresión) se estimó con el análisis de supervivencia de Kaplan-Meier. Las tasas de supervivencia libre de enfermedad se analizaron mediante un modelo multivariable de regresión de Cox de riesgos proporcionales. La mediana del tiempo de seguimiento fue de 24 y 50 meses en las muestras de 2019 y 2017, respectivamente, con una mediana del número de instilaciones de 8 y 12, respectivamente. Se observó una mediana de tiempo hasta la recurrencia de 285 días (145–448) durante 2019 y de 382 días (215–567) en 2017 (log-rank p = 0,025). Un análisis multivariable adicional reveló un HR proporcional para la tasa de supervivencia libre de enfermedad de 1,87 (IC 95%: 1,04–3,37 p = 0,036). No se observaron diferencias estadísticamente significativas en las características de la recaída tumoral. El desabastecimiento de BCG y los posteriores esquemas de dosis reducidas debido a este aumentan las tasas de recaída tumoral precoz. Estos resultados coinciden con la evidencia disponible, demostrando la necesidad de dosis completas de BCG.
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ISSN:2173-5786
2173-5786
DOI:10.1016/j.acuroe.2023.01.005