In this setting, BCG shortages represents a serious crisis for the management of high-grade NMIBC. There are currently eight strains of BCG produced worldwide: Japan, Moreau, Russia, Connaught, Danish, Glaxo, Phipps and Tice. However, during the worldwide shortage of the Connaught and Tice strains, the European and American markets were hit hard. Additionally, recent studies have begun to demonstrate different degrees of efficacy and complication risk.
In this study, the authors assess the efficacy of the BCG Moreau strain, which is the most commonly utilized strain in Brazil, and which was recently introduced to the European market to cover the issue of BCG shortage. This was a retrospective single-institution study of 336 consecutive patients treated with adjuvant intravesical BCG Moreau instillation therapy for intermediate- and high-risk NMIBC between January 2005 and February 2015. The end points of this study were time to first recurrence and progression to muscle-invasive disease.
In terms of patient demographics, median age was 62 years. Of the entire cohort, 228 (67.9%) patients received maintenance BCG in addition to induction BCG; however, 35 (15.4%) patients interrupted maintenance BCG due to toxicity, so only 193 received complete induction and maintenance therapy.
Overall, after at least a complete induction BCG therapy, 87 (25.9%) patients presented with disease recurrence and 33 (9.8%) patients had disease progression. When analyzing only patients who received BCG maintenance in addition to induction therapy, 31 (13.6%) patients had disease recurrence and 10 (4.4%) had disease progression, which is consistent with prior studies which emphasized the importance of maintenance therapy.
The 5-year recurrence-free survival and progression-free survival rate was 69.8% (95% CI 52.8-77.2) and 86.2% (95% CI 69.9-93.2), respectively. Based on this, the authors conclude that BCG Moreau was safe and effective, as the results were comparable to other strains.
However, standardization is an important issue. Further prospective studies need to be done to determine the best BCG strain and concerted efforts need to be made to avoid future shortages.
Presented By: Daher Cezar Chade
Co-Authors: Andre Machado, Ricardo Waksman, Guilherme Garcia, Paulo Esteves, Sanarelly Adonias, Luis Botelho, Mauricio Cordeiro, Claudio Murta, Leopoldo Ribeiro-Filho, Alvaro Sarkis, Diogo Assed Bastos, Carlos Dzik, Miguel Srougi, William Carlos Nahas
Institution(s): Andre Machado, Ricardo Waksman, Guilherme Garcia, Paulo Esteves, Sanarelly Adonias, Luis Botelho, Mauricio Cordeiro, Claudio Murta, Leopoldo Ribeiro-Filho, Alvaro Sarkis, Diogo Assed Bastos, Carlos Dzik, Miguel Srougi, William Carlos Nahas
Written By: Thenappan Chandrasekar, MD, Clinical Fellow, University of Toronto, Princess Margaret Cancer Centre
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA