Bacillus Calmette-Guerin Tokyo172 Substrain for Superficial Bladder Cancer: Characterization and Antitumor Effect

Ikeda, Noriko; Honda, Ikuro; Yano, Ikuya; Koyama, Akira; Toida, Ichiro

doi:10.1097/01.ju.0000154354.06892.ba

Cited by 21 publications

(19 citation statements)

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“…Fourth, one confounding issue that could have a clinical impact on all presented studies including ours is the fact that the number of colony-forming units is different in various strains [23]. However, in the study conducted by Inamoto et al [24] comparing low-dose Tokyo 172 strain and regular dose Connaught strain, it was shown that low-dose Tokyo 172 strain caused less adverse events, although the difference was not significant.…”

Section: Limitations and Strengthsmentioning

confidence: 59%

Are There Differences in Toxicity and Efficacy between Various Bacillus Calmette-Guerin Strains in Bladder Cancer Patients? Analysis of 844 Patients

et al. 2018

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Purpose: To evaluate if there are differences in toxicity and efficacy between different Bacillus Calmette-Guerin (BCG) stains used for intravesical immunotherapy in patients with non-muscle invasive bladder cancer. Methods: We retrospectively analysed a group of 844 patients who received TICE, RIVM and Moreau BCG strains. The allocation of the strain to each patient was random, stemming from differences in supply and distribution. The patients were analysed in terms of toxicity, recurrence-free (RFS), progression-free (PFS), cancer-specific (CSS) and overall survival (OS). Results: In the survival analysis, statistical significance was not reached in any tumour group for any clinical event. TICE caused more local and mild adverse effects and severe complications were mainly associated with RIVM strain. In a group in which the strain was changed during the course of the therapy, significantly more severe complications were observed and, in most of these cases, complications appeared right after the strain change. Conclusions: There were no differences in terms of RFS, PFS, CSS and OS after use of TICE, RIVM and Moreau strains. The complication profile differed statistically between used strains with TICE causing mostly mild complications. Also, strain change during the therapy course was associated with the increased risk of moderate to severe toxicity occurrence.

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Section: Limitations and Strengthsmentioning

confidence: 59%

Are There Differences in Toxicity and Efficacy between Various Bacillus Calmette-Guerin Strains in Bladder Cancer Patients? Analysis of 844 Patients

et al. 2018

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“…Two year recurrence free survival rates weren't significantly different: 73.2% and 68.8%, respectively. These two strains have also been compared in a mouse model [9]. Tumor cells with various doses of both BCG strains were injected in the flank of syngenic mice.Tokyo172 achieved similar tumor suppression at a lower dose than Connaught.…”

Section: Discussionmentioning

confidence: 99%

The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer

Witjes

Dalbagni

Karnes

et al. 2016

Urologic Oncology: Seminars and Original Investigations

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Background Potential differences in efficacy of different BCG strains are of importance for daily practice, especially in the era of BCG shortage. Objective To retrospectively compare the outcome with BCG Connaught and BCG Tice in a large study cohort of pT1 high grade non muscle-invasive bladder cancer (NMIBC) patients. Design, setting, and participants Individual patient data were collected for 2451 patients with primary T1G3 tumors from 23 centers who were treated with BCG for the first time between 1990 and 2011. Outcome measurements and statistical analysis Using Cox multivariable regression and adjusting for the most important prognostic factors in this non randomized comparison, BCG Connaught and TICE were compared for time to recurrence, progression and the duration of cancer specific (CSS) and overall survival (OS). Results and limitations Information on the BCG strain was available for 2099 patients: 957 on Connaught and 1142 on TICE. 765 (36%) patients received some form of maintenance BCG, 560 (59%) on Connaught and 205 (18%) on TICE. Without maintenance, Connaught was more effective than TICE only for the time to first recurrence (HR = 1.48, 95% CI: 1.20 – 1.82, p < 0.001). With maintenance, TICE was more effective than Connaught for the time to first recurrence (HR = 0.66, 95% CI: 0.47 – 0.93, p=0.019) with a trend for CSS (HR = 0.36, 95% CI: 0.14 – 0.92, p = 0.033). For time to progression and OS, Connaught and TICE had a similar efficacy. Compared to no maintenance therapy, maintenance BCG significantly reduced the risk of recurrence, progression and death, both overall and disease specific, for TICE but not for Connaught. Conclusions We found that BCG Connaught results in a lower recurrence rate as compared to BCG Tice when no maintenance is used. However, the opposite is true when maintenance is given. Patient summary Since there is currently a BCG shortage, information on the efficacy of different BCG strains is important. In this non randomized retrospective comparison in over 2000 patients, we found that BCG Connaught reduces the recurrence rate compared to BCG Tice when no maintenance is used, but the opposite is true when maintenance is given.

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“…50 Theoretically a BCG preparation with high viability, good dispersion and smaller bacillus size might be better able to enter the systemic circulation to cause serious infection. The doses stated on the BCG product labels are approximately the same (80 mg for the Tokyo 172 strain and 81 mg for the Connaught strain), but the Connaught strain is provided in powder form, whereas the Tokyo 172 strain has 70% moisture content.…”

Section: Different Clinical Outcomes Afforded By Bcg Strainsmentioning

confidence: 99%

Bacillus Calmette–Guérin strain differences as the basis for immunotherapies against bladder cancer

et al. 2018

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In the past 40 years, intravesical immunotherapy with Mycobacterium bovis bacillus Calmette-Guérin has been carried out as the most effective treatment for preventing local recurrences and tumor progression of non-muscle-invasive bladder cancer. Bacillus Calmette-Guérin is a family of vaccines derived in 1921 by the in vitro attenuation of Mycobacterium bovis. Subsequently, bacillus Calmette-Guérin seed lots were spread around the world, and both phenotypic and genotypic differences among the strains have been compiled. In recent genomic comparisons, the evolution of the different bacillus Calmette-Guérin substrains has begun to emerge. However, some of these genetic alterations in bacillus Calmette-Guérin strains have yet to be shown to affect the therapeutic effects and/or adverse effects. There are thus ongoing research efforts to assess the effects of these genetic alterations on the properties of bacillus Calmette-Guérin strains, with the ultimate goal of identifying an ideal bacillus Calmette-Guérin strain for treatment of non-muscle-invasive bladder cancer and providing clues for the improvement of bacillus Calmette-Guérin strains. The present review provides a history of bacillus Calmette-Guérin immunotherapy, and discusses the genetic differences among bacillus Calmette-Guérin strains, the different clinical outcomes afforded by bacillus Calmette-Guérin strains and possible future developments.

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Bacillus Calmette-Guerin Tokyo172 Substrain for Superficial Bladder Cancer: Characterization and Antitumor Effect

Abstract: High viability, good dispersion and efficient binding to tumor cells by BCG bacilli in the Tokyo172 preparation seem to be the main reasons for the lower clinical dose of this preparation compared with the Connaught preparation (18 vs 81 mg dry weight).

Cited by 21 publications

References 12 publications

Are There Differences in Toxicity and Efficacy between Various Bacillus Calmette-Guerin Strains in Bladder Cancer Patients? Analysis of 844 Patients

Are There Differences in Toxicity and Efficacy between Various Bacillus Calmette-Guerin Strains in Bladder Cancer Patients? Analysis of 844 Patients

The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer

Bacillus Calmette–Guérin strain differences as the basis for immunotherapies against bladder cancer

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