A systematic review and meta-analysis on the safety and efficacy of different strains of Mycobacterium bovis bacillus Calmette-Guérin for non-muscle invasive bladder cancer in Japan and US

Shiro Hinotsu, Naoyuki Kamatani, Timothy L. Ratliff, Hideyuki Akaza

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objective: To compare efficacy and safety of different strains of Mycobacterium bovis bacillus Calmette-Guérin (BCG) used in Japan and the US as intravesical therapeutics for non-muscle invasive bladder cancer. Materials and methods: Papers for review were selected from PubMed and Igakuchuozasshi databases, and meta-analysis was performed using the data obtained. Results: 352 papers from Japanese hospitals and 333 papers from US hospitals were reviewed. Strains used in Japan were Immunobladder®> (Tokyo 172) and ImmuCyst® (Connaught (JP)), while those used in the US were TICE® (TICE) and TheraCys® (Connaught (US)). CR (complete remission) rates for patients with CIS (carcinoma in situ) were 0.824 (n = 380, 95% CI 0.782–0.861), 0.868 (n = 38, 95% CI 0.719–0.956), 0.714 (n = 35, 95% CI 0.537–0.854) and 0.574 (n = 385, 95% CI 0.523–0.624) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Non- recurrence survival (NRS) rates for non-CIS patients were 0.754 (n = 429, 95% CI 0.714–0.794), 0.790 (n = 83, 95% CI 0.702–0.878), 0.673 (n = 250, 95% CI 0.615–0.731) and 0.598 (n = 255, 95% CI 0.538–0.658) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Conclusion: No significant differences were observed neither in efficacy nor in safety between two strains of BCG used Japan and the US. However, the rates of CR and NRS may be higher in Japan than the US, and the rates of severe adverse events may be higher in Japan than the US, although the data were not from controlled studies.

Original languageEnglish
Pages (from-to)8-18
Number of pages11
JournalEuropean Journal of Oncology Pharmacy
Volume8
Issue number4
Publication statusPublished - 2015

Fingerprint

Mycobacterium bovis
Urinary Bladder Neoplasms
Bacillus
Meta-Analysis
Japan
Tokyo
Safety
Recurrence
Carcinoma in Situ
PubMed
Survival Rate
Databases
Survival
Therapeutics

Keywords

  • Bacillus Calmette-Guérin (BCG)
  • Bladder cancer
  • Ethnicity
  • Strain

ASJC Scopus subject areas

  • Oncology
  • Pharmacology

Cite this

A systematic review and meta-analysis on the safety and efficacy of different strains of Mycobacterium bovis bacillus Calmette-Guérin for non-muscle invasive bladder cancer in Japan and US. / Hinotsu, Shiro; Kamatani, Naoyuki; Ratliff, Timothy L.; Akaza, Hideyuki.

In: European Journal of Oncology Pharmacy, Vol. 8, No. 4, 2015, p. 8-18.

Research output: Contribution to journalArticle

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abstract = "Objective: To compare efficacy and safety of different strains of Mycobacterium bovis bacillus Calmette-Gu{\'e}rin (BCG) used in Japan and the US as intravesical therapeutics for non-muscle invasive bladder cancer. Materials and methods: Papers for review were selected from PubMed and Igakuchuozasshi databases, and meta-analysis was performed using the data obtained. Results: 352 papers from Japanese hospitals and 333 papers from US hospitals were reviewed. Strains used in Japan were Immunobladder{\circledR}> (Tokyo 172) and ImmuCyst{\circledR} (Connaught (JP)), while those used in the US were TICE{\circledR} (TICE) and TheraCys{\circledR} (Connaught (US)). CR (complete remission) rates for patients with CIS (carcinoma in situ) were 0.824 (n = 380, 95{\%} CI 0.782–0.861), 0.868 (n = 38, 95{\%} CI 0.719–0.956), 0.714 (n = 35, 95{\%} CI 0.537–0.854) and 0.574 (n = 385, 95{\%} CI 0.523–0.624) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Non- recurrence survival (NRS) rates for non-CIS patients were 0.754 (n = 429, 95{\%} CI 0.714–0.794), 0.790 (n = 83, 95{\%} CI 0.702–0.878), 0.673 (n = 250, 95{\%} CI 0.615–0.731) and 0.598 (n = 255, 95{\%} CI 0.538–0.658) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Conclusion: No significant differences were observed neither in efficacy nor in safety between two strains of BCG used Japan and the US. However, the rates of CR and NRS may be higher in Japan than the US, and the rates of severe adverse events may be higher in Japan than the US, although the data were not from controlled studies.",
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AU - Hinotsu, Shiro

AU - Kamatani, Naoyuki

AU - Ratliff, Timothy L.

AU - Akaza, Hideyuki

PY - 2015

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N2 - Objective: To compare efficacy and safety of different strains of Mycobacterium bovis bacillus Calmette-Guérin (BCG) used in Japan and the US as intravesical therapeutics for non-muscle invasive bladder cancer. Materials and methods: Papers for review were selected from PubMed and Igakuchuozasshi databases, and meta-analysis was performed using the data obtained. Results: 352 papers from Japanese hospitals and 333 papers from US hospitals were reviewed. Strains used in Japan were Immunobladder®> (Tokyo 172) and ImmuCyst® (Connaught (JP)), while those used in the US were TICE® (TICE) and TheraCys® (Connaught (US)). CR (complete remission) rates for patients with CIS (carcinoma in situ) were 0.824 (n = 380, 95% CI 0.782–0.861), 0.868 (n = 38, 95% CI 0.719–0.956), 0.714 (n = 35, 95% CI 0.537–0.854) and 0.574 (n = 385, 95% CI 0.523–0.624) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Non- recurrence survival (NRS) rates for non-CIS patients were 0.754 (n = 429, 95% CI 0.714–0.794), 0.790 (n = 83, 95% CI 0.702–0.878), 0.673 (n = 250, 95% CI 0.615–0.731) and 0.598 (n = 255, 95% CI 0.538–0.658) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Conclusion: No significant differences were observed neither in efficacy nor in safety between two strains of BCG used Japan and the US. However, the rates of CR and NRS may be higher in Japan than the US, and the rates of severe adverse events may be higher in Japan than the US, although the data were not from controlled studies.

AB - Objective: To compare efficacy and safety of different strains of Mycobacterium bovis bacillus Calmette-Guérin (BCG) used in Japan and the US as intravesical therapeutics for non-muscle invasive bladder cancer. Materials and methods: Papers for review were selected from PubMed and Igakuchuozasshi databases, and meta-analysis was performed using the data obtained. Results: 352 papers from Japanese hospitals and 333 papers from US hospitals were reviewed. Strains used in Japan were Immunobladder®> (Tokyo 172) and ImmuCyst® (Connaught (JP)), while those used in the US were TICE® (TICE) and TheraCys® (Connaught (US)). CR (complete remission) rates for patients with CIS (carcinoma in situ) were 0.824 (n = 380, 95% CI 0.782–0.861), 0.868 (n = 38, 95% CI 0.719–0.956), 0.714 (n = 35, 95% CI 0.537–0.854) and 0.574 (n = 385, 95% CI 0.523–0.624) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Non- recurrence survival (NRS) rates for non-CIS patients were 0.754 (n = 429, 95% CI 0.714–0.794), 0.790 (n = 83, 95% CI 0.702–0.878), 0.673 (n = 250, 95% CI 0.615–0.731) and 0.598 (n = 255, 95% CI 0.538–0.658) for Tokyo 172, Connaught (JP), TICE and Connaught (US), respectively. Conclusion: No significant differences were observed neither in efficacy nor in safety between two strains of BCG used Japan and the US. However, the rates of CR and NRS may be higher in Japan than the US, and the rates of severe adverse events may be higher in Japan than the US, although the data were not from controlled studies.

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