A prospective comparative study of intravesical bacillus Calmette-Guérin therapy with the Tokyo or Connaught strain for nonmuscle invasive bladder cancer.

Abstract

PURPOSE:

We prospectively compared the efficacy and adverse events of the bacillus Calmette-Guérin Tokyo 172 and Connaught strains for nonmuscle invasive bladder cancer.

MATERIALS AND METHODS:

Between January 2004 and May 2012 patients with pTa/T1 and pTis, multiple tumors and a recurrence-free period of 3 months or less who required intravesical bacillus Calmette-Guérin therapy were prospectively allocated randomly to receive the Tokyo or Connaught strain. The primary study end points were the complete response rate in patients with pTis and concomitant carcinoma in situ (pTa or pT1), recurrence-free survival in patients with pTa, pT1 and carcinoma in situ who achieved a complete response after therapy and the frequency of adverse events.

RESULTS:

Administration of the Connaught strain ceased because its production was suspended in June 2012. Therefore, analysis was performed using data gathered to date. Overall, 66 and 63 patients who received the Tokyo and Connaught strains, respectively, were included in efficacy analysis. Patient and tumor characteristics were well balanced between the 2 groups. Median followup was 855 days. Adverse events were similar in the groups. The complete response rate was 90.3% and 85.0% in patients given the Tokyo and Connaught strains, respectively, which did not significantly differ (p = 0.896). The 2-year recurrence-free survival rate was 73.2% and 68.8%, respectively.

CONCLUSIONS:

Results suggest no significant differences between the Tokyo and Connaught strains in the complete response, recurrence-free survival or adverse event rate.

• Authors: Atsushi Sengiku, Masaaki Ito, Yu Miyazaki, Harutake Sawazaki, Takeshi Takahashi, Keiji Ogura
• Journal: The Journal of urology (J Urol) Vol. 190 Issue 1 Pg. 50-4 (Jul 2013) ISSN: 1527-3792 [Electronic] United States
• PMID: 23376145 (Publication Type: Clinical Trial, Comparative Study, Journal Article)
• Copyright: Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• BCG Vaccine

Topics

• Administration, Intravesical
• Aged
• Aged, 80 and over
• BCG Vaccine (administration & dosage, classification)
• Carcinoma, Transitional Cell (drug therapy, mortality, pathology)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Neoplasm Invasiveness (pathology)
• Neoplasm Recurrence, Local (mortality, pathology)
• Neoplasm Staging
• Patient Safety
• Prospective Studies
• Risk Assessment
• Statistics, Nonparametric
• Survival Rate
• Treatment Outcome
• Urinary Bladder Neoplasms (drug therapy, mortality, pathology)