Scientific publications
Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice
Unda-Urzaiz M (1), Cozar-Olmos JM (2), Miñana-Lopez B (3), Camarero-Jimenez J (4), Brugarolas-Rossello X (5), Zubiaur-Libano C (6), Ribal-Caparros MJ (7), Suarez-Charneco AJ (2), Rodriguez-Tesedo V (8), Chantada-Abal V (9), Ruiz-de-Leon C (10), Carrillo-George C (11), Carballido-Rodriguez J (12), Villacampa-Auba F (13); en representación del Grupo Español del Registro de Cepas de BCG.
(1) Servicio de Urología, Hospital Universitario Basurto, Bilbao, España.
(2) Servicio de Urología, Hospital Universitario Virgen de las Nieves, Granada, España.
(3) Servicio de Urología, Clínica Universitaria de Navarra, Pamplona, España.
(4) Agencia Española del Medicamento y Productos Sanitarios, España.
(5) Servicio de Urología, Hospital Son Espases, Palma de Mallorca, España.
(6) Servicio de Urología, Hospital Universitario Basurto, Bilbao, España.
(7) Servicio de Urología, Hospital Clínic, Barcelona, España.
(8) Servicio de Urología, Hospital Rio Ortega, Valladolid, España.
(9) Servicio de Urología, Complejo Hospitalario Universitario de A Coruña, A Coruña, España.
(10) Servicio de Urología, Hospital Universitario Central de Asturias, Oviedo, España.
(11) Servicio de Urología, Hospital Morales Meseguer, Murcia, España.
(12) Servicio de Urología, Hospital Universitario Puerta de Hierro, Madrid, España.
(13) Servicio de Urología, Hospital Universitario 12 de Octubre, Madrid, España.
BACKGROUND:
The natural progression of bladder tumours (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=.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=.69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.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 grade1. 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.
CITATION Actas Urol Esp. 2017 Dec 30. pii: S0210-4806(17)30221-8. doi: 10.1016/j.acuro.2017.10.003
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