Treatment of non muscle invasive bladder tumor related to the problem of Bacillus Calmette-Guerin availability. Consensus of a Spanish expert's panel - Abstract

CONTEXT: Since June 2012, there has been a worldwide lack of available of the Connaught strain. In December 2012, a group of experts met in the Spanish Association of Urology to analyze this situation and propose alternatives.

OBJECTIVE: To present the work performed by said committee and the resulting recommendations.

The Spanish Agency for Medicines and Health Products reports on the shortage of BCG immunotherapeutic Immu-cyst. They are taking the necessary steps to ensure the availability of other alternatives authorized in Spain or imported as foreign medication. Click HERE to read the recommendations of the working group on BCG and its availability in Spain.

ACQUISITION OF EVIDENCE: An update has been made of the principal existing evidence in the treatment of middle and high risk tumors. Special mention has been made regarding the those related with the use of BCG and their possible alternative due to the different availability of BCG.

EVIDENCE SYNTHESIS: In tumors with high risk of progression, immediate cystectomy should be considered when BCG is not available, with dose reduction or alternating with chemotherapy as methods to economize on the use of BCG when availability is reduced. In tumors having middle risk of progression, chemotherapy can be used, although when it is associated to a high risk of relapse, BCG would be indicated if available with the mentioned savings guidelines. BCG requires maintenance to maintain its effectiveness, it being necessary to optimize the application of endovesical chemotherapy and to use systems that increase its penetration into the bladder wall (EMDA) if they are available.

CONCLUSIONS: Due to the scarcity of BCG, it has been necessary to agree on a series of recommendations that have been published on the web page of the Spanish Association of Urology.

Written by:
Fernández-Gómez JM, Carballido-Rodríguez J, Cozar-Olmo JM, Palou-Redorta J, Solsona-Narbón E, Unda-Urzaiz JM.   Are you the author?
Servicio de Urología, Hospital Universitario Central de Asturias, Universidad de Oviedo, Oviedo, España.

Reference: Actas Urol Esp. 2013 July - August;37(7):387-394.
doi: 10.1016/j.acuro.2013.04.002


PubMed Abstract
PMID: 23773824

Article in English, Spanish.

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