Publicaciones científicas
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.
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.
CITA DEL ARTÍCULO Actas Urol Esp. 2017 Dec 30. pii: S0210-4806(17)30221-8. doi: 10.1016/j.acuro.2017.10.003
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