title: Comparable effect with minimal morbidity of low-dose Tokyo 172 strain compared with regular dose Connaught strain as an intravesical bacillus Calmette-Guérin prophylaxis in nonmuscle invasive bladder cancer: Results of a randomized prospective comparison.
abstract: OBJECTIVE
  The aim was to compare patients' morbidity and response of bacillus Calmette-Guérin (BCG) prophylaxis after the intravesical instillation of low-dose Tokyo 172 strain and regular dose Connaught strain in patients with nonmuscle invasive bladder cancer (NMIBC).
  
  
  METHODS
  This was a randomized, active-controlled, open-label, monocenter study. Thirty-eight, NMIBC patients were treated sequentially, in a random order, with low-dose Tokyo 172 strain and regular dose Connaught strain, receiving each therapy for 6 weeks. A total of 18 and 20 patients were randomly assigned to a Tokyo 172 strain arm and a Connaught strain arm, respectively. Complication, morbidity, and recurrence-free survival (RFS) after each treatment were compared.
  
  
  RESULTS
  There was no significant difference in the 1-year RFS rate in patients treated with Tokyo 172 strain and Connaught strain (72.2% vs. 83.5%, respectively; P = 0.698). There were no significant differences in adverse events between the arms. Severe adverse events (>Grade 3) were seen in 15% of the Connaught strain group while no severe adverse events were observed as a result of Tokyo 172 strain.
  
  
  CONCLUSIONS
  Our results indicated that low-dose Tokyo 172 strain decreased adverse events although it was not significant, and the RFS difference was not statistically significant between the two arms. Further investigation is warranted.
authors: Department of Urology, Osaka Medical College, Osaka, Japan.
authors: Teruo
authors: T
authors: Inamoto
authors: Takanobu
authors: T
authors: Ubai
authors: Takeshi
authors: T
authors: Nishida
authors: Yutaka
authors: Y
authors: Fujisue
authors: Yoji
authors: Y
authors: Katsuoka
authors: Haruhito
authors: H
authors: Azuma
keywords: Bacillus Calmette–Guérin; Tokyo 172 strain; bladder cancer; intravesical instillation
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