A prospective comparative study of intravesical Bacillus Calmette-Guérin therapy with the Tokyo or Connaught strains for non-muscle invasive bladder cancer
Sengiku A, Ito M, Miyazaki Y, Sawazaki H, Takahashi T, Ogura K. J Urol. 2013 Jan 30. pii: S0022-5347(13)00224-3. doi: 10.1016/j.juro.2013.01.084. [Epub ahead of print]

Source

Department of Urology, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan. Electronic address: sengiku@kuhp.kyoto-u.ac.jp.

Abstract

PURPOSE:

We conducted a prospective study to compare the efficacy and adverse events of the Bacillus Calmette-Guérin Tokyo 172 and Connaught strains for non-muscle invasive bladder cancer.

MATERIALS AND METHODS:

Between January 2004 and May 2012, patients with pTa/T1 and pTis, multiple tumors, recurrence-free period of ≤3 months and who required intravesical BCG therapy were prospectively and randomly allocated to receive either the Tokyo or Connaught strain. The primary endpoints included the complete response (CR) rate in patients with pTis and concomitant carcinoma in situ (CIS) (pTa or pT1); the recurrence-free survival (RFS) for patients with pTa, pT1, and CIS who achieved CR after BCG therapy; and the frequencies of adverse events.

RESULTS:

Administration of the Connaught strain was ceased because its production was suspended in June 2012. Therefore, the analyses were conducted using data gathered to date. Overall, 129 patients (Tokyo strain, n = 66; Connaught strain, n = 63) were included in the efficacy analyses. The patient and tumor characteristics were well balanced between the two groups. The median follow-up time was 855 days. The adverse events were similar in both groups. The CR rate was 90.3% and 85.0% in patients given the Tokyo and Connaught strains, respectively; this was not significantly different (p = 0.896). The 2-year RFS was 73.2% and 68.8% for the Tokyo and Connaught strains, respectively.

CONCLUSIONS:

Our results suggest that there are no significant differences between the Tokyo and Connaught strains in terms of the rates of CR, RFS, or adverse events.