The Moreau Strain of Bacillus Calmette-Guerin (BCG) for High-Risk Non-Muscle Invasive Bladder Cancer: An Alternative during Worldwide BCG Shortage?

Abstract

Background: Bacillus Calmette-Guerin (BCG) is the standard of care for adjuvant intravesical instillation therapy for intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) after complete transurethral resection. Increasing evidence suggests that there are marked differences in outcomes according to BCG substrains. BCG-Moreau was recently introduced to the European market to cover the issue of BCG shortage, but there are little data regarding the oncologic efficacy. Methods: We retrospectively analyzed 295 consecutive patients, who received adjuvant intravesical instillation therapy with BCG-Moreau for intermediate- and high-risk NMIBC between October 2007 and April 2013 at a single institution. The end points of this study were time to first recurrence and progression to muscle-invasive disease. Results: Median age was 66 years (interquartile range 59-74, mean 65.9 years). According to the EAU risk group, 76 patients presented with intermediate-risk and 219 patients with high-risk NMIBC. The 5-year recurrence-free survival and progression-free survival rate was 64.8% (95% CI 52.8-74.4) and 81.4% (95% CI 65.2-90.2), respectively. Conclusions: BCG-Moreau is an effective substrain for adjuvant instillation therapies of NMIBC, and outcomes appear to be comparable to series using other substrains. During worldwide shortage of BCG-TICE, Connaught and RIVM, BCG-Moreau may serve as an equally effective alternative.

Impact of Adjuvant Intravesical Bacillus Calmette-Guérin Treatment on Patients with High-Grade T1 Bladder Cancer

“…The fact that suboptimal courses of BCG instillations may result in higher recurrence rates should not be overlooked, and for the very highest risk cases, higher progression rates with subsequent increase in T1 high-grade tumor mortality rate were observed [3]. Hofbauer et al [17] showed that some rarely used BCG strains such as BCG-Moreau strain can replace commonly used strains and thus may contribute to solve that shortage. This potential alternative from Biomed Lublin (Lublin, Poland), BCG-Moreau, has recently been introduced in the European market.…”

High-Grade T1 on Re-Transurethral Resection after Initial High-Grade T1 Confers Worse Oncological Outcomes: Results of a Multi-Institutional Study

“…Pathological evaluation was carried out according to the TNM system of Union for International Cancer Control and to the 1973 World Health Organization grading classification [19]. Patients with NMIBC on re-TUR and those with no residual tumor received an induction 6 weeks course of intravesical BCG followed by standard maintenance scheme, which consisted of intravesical BCG -standard dose -every week for 3 weeks given at 3, 6, 12, 18, 24, 30, and 36 months from initiation of therapy [20]. Only 303 (29%) patients completed the treatment protocol as planned [21].…”

Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution

“…As an example, Sanofi Pasteur, one of the major producers of BCG, the current vaccine for TB, experienced significant manufacturing problems during 2012 and 2014. As a result, distribution of this vaccine was seriously compromised in several countries ( 123 ). Indeed, approximately 16.5 million doses shortfall of BCG occurred at the end of 2015 was estimated, using mathematical models, to be associated with 7,433 excess of TB deaths worldwide ( 124 ).…”