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Inicio Actas Urológicas Españolas (English Edition) Safety and efficacy of various strains of bacille Calmette–Guérin in the trea...
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Vol. 42. Issue 4.
Pages 238-248 (May 2018)
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Vol. 42. Issue 4.
Pages 238-248 (May 2018)
Original article
Safety and efficacy of various strains of bacille Calmette–Guérin in the treatment of bladder tumors in standard clinical practice
Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual
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M. Unda-Urzaiza,
Corresponding author
, J.M. Cozar-Olmosb, B. Miñana-Lopezc, J. Camarero-Jimenezd, X. Brugarolas-Rosselloe, C. Zubiaur-Libanoa, M.J. Ribal-Caparrosf, A.J. Suarez-Charnecob, V. Rodriguez-Tesedog, V. Chantada-Abalh, C. Gonzalez-Ruiz-de-Leoni, C. Carrillo-Georgej, J. Carballido-Rodriguezk, F. Villacampa-Aubal, on behalf of the Grupo Español del Registro de Cepas de BCG
a Servicio de Urología, Hospital Universitario Basurto, Bilbao, Spain
b Servicio de Urología, Hospital Universitario Virgen de las Nieves, Granada, Spain
c Servicio de Urología, Clínica Universitaria de Navarra, Pamplona, Spain
d Agencia Española del Medicamento y Productos Sanitarios, Spain
e Servicio de Urología, Hospital Son Espases, Palma de Mallorca, Spain
f Servicio de Urología, Hospital Clínic, Barcelona, Spain
g Servicio de Urología, Hospital Rio Ortega, Valladolid, Spain
h Servicio de Urología, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain
i Servicio de Urología, Hospital Universitario Central de Asturias, Oviedo, Spain
j Servicio de Urología, Hospital Morales Meseguer, Murcia, Spain
k Servicio de Urología, Hospital Universitario Puerta de Hierro, Madrid, Spain
l Servicio de Urología, Hospital Universitario 12 de Octubre, Madrid, Spain
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Tables (5)
Table 1. Pathological variables of the current episode of bladder cancer.
Table 2. Recurrences of the tumor at 2 months.
Table 3. Tumor progression at 12 months.
Table 4. Adverse effects.
Table 5. Association of carrying out a maintenance cycle with the effectiveness and tolerability of BCG.
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Abstract
Background

The natural progression of bladder tumors (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette–Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains.

Material and methods

An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains.

Results

The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced.

DFS

There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; p=0.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; p=0.69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; p=0.93).

In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) <48h, >48h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade 1. There were no statistically significant differences between the strains.

Conclusions

In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed.

Keywords:
Bladder cancer
BCG
Strains
Resumen
Introducción

La evolución natural del tumor vesical no músculo infiltrante (TVNMI) es la recidiva con elevado porcentaje de progresión. La BCG se ha demostrado eficaz para disminuir estos porcentajes, pero hay pocos estudios comparativos entre cepas.

Material y métodos

Registro observacional, prospectivo y multicéntrico, estudiándose 433 pacientes con visita de seguimiento a 12meses de 961 registrados y evaluado supervivencia libre de enfermedad (SLE), de progresión (SLP) cáncer-específica (SE) y efectos adversos. Se estudiaron las cepas Tice, Russian, Tokyo, Connaught y RIVM.

Resultados

Los datos sociodemográficos, antecedentes de TVNMI, comorbilidades, tamaño, número, estadio, grado, CIS asociado y Re-RTU, están bien balanceados.

SLE

85 recidivas (19,6%). La mediana del tiempo de SLE fue 20meses. Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p=0,93). SLP: 33 progresiones (7,62%). Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p=0,69). SE: fallecieron 7 pacientes (1,68%). Al comparar la SE entre las diferentes cepas, no se detectaron diferencias (Log-rank test, p=0,93). En seguridad, el 33,3% habían presentado algún tipo de efecto adverso, mayoritariamente clínica urinaria baja no ITU<48h, >48h y hematuria. Según los Common Toxicity Criteria de la European Organization for Research and Treatment of Cancer, el 92,7% eran grado1. No se obtuvieron diferencias estadísticamente significativas relevantes entre cepas.

Conclusiones

En este análisis intermedio, el riesgo de recidiva, progresión, muerte específica y seguridad es independiente de la cepa de BCG utilizada.

Palabras clave:
Cáncer vesical
BCG
Cepas

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