title: A prospective comparative study of intravesical bacillus Calmette-Guérin therapy with the Tokyo or Connaught strain for nonmuscle invasive bladder cancer.
abstract: OBJECTIVE
  We prospectively compared the efficacy and adverse events of the bacillus Calmette-Guérin Tokyo 172 and Connaught strains for nonmuscle invasive bladder cancer.
  
  
  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: Department of Urology, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan. sengiku@kuhp.kyoto-u.ac.jp
authors: Atsushi
authors: A
authors: Sengiku
authors: Masaaki
authors: M
authors: Ito
authors: Yu
authors: Y
authors: Miyazaki
authors: Harutake
authors: H
authors: Sawazaki
authors: Takeshi
authors: T
authors: Takahashi
authors: Keiji
authors: K
authors: Ogura
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000145:classification*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D061214:Patient Safety; D011446:Prospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*
chemical_list: D001500:BCG Vaccine