A Prospective Comparative Study of Intravesical Bacillus Calmette-Guérin Therapy with the Tokyo or Connaught Strain for Nonmuscle Invasive Bladder Cancer

• Published in: The Journal of urology Vol. 190; no. 1; pp. 50 - 54
• Main Authors: Sengiku, Atsushi, Ito, Masaaki, Miyazaki, Yu, Sawazaki, Harutake, Takahashi, Takeshi, Ogura, Keiji
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.07.2013; Elsevier
• Subjects: Administration, Intravesical; Aged; Aged, 80 and over; Bacterial diseases; BCG Connaught; BCG vaccine; BCG Vaccine - administration & dosage; BCG Vaccine - classification; Biological and medical sciences; Carcinoma, Transitional Cell - drug therapy; Carcinoma, Transitional Cell - mortality; Carcinoma, Transitional Cell - pathology; Disease-Free Survival; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Human bacterial diseases; Humans; Infectious diseases; Japan; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Neoplasm Invasiveness - pathology; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - pathology; Neoplasm Staging; Nephrology. Urinary tract diseases; Patient Safety; Prospective Studies; Risk Assessment; Statistics, Nonparametric; Survival Rate; Treatment Outcome; Tuberculosis and atypical mycobacterial infections; Tumors of the urinary system; urinary bladder neoplasms; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - mortality; Urinary Bladder Neoplasms - pathology; Urinary tract. Prostate gland; Urology; Asia; Japan; carcinoma in situ; bacillus Calmette-Guérin; BCG Connaught; NMIBC; TURBT; Japan; BCG; complete response; nonmuscle invasive bladder cancer; CIS; BCG vaccine; treatment outcome; CR; transurethral resection of bladder tumor; recurrence-free survival; urinary bladder neoplasms; RFS; Nephrology; Prognosis; Urology; Prospective; Prevention; Urinary bladder; Invasive cancer; Urinary system disease; Vaccine; Urinary tract disease; Malignant tumor; Bladder cancer; Bladder tumor; Strain; Immunoprophylaxis; Treatment; Urinary system; Bladder disease; Intravesical administration; Comparative study; Cancer
• ISSN: 0022-5347; 1527-3792
• DOI: 10.1016/j.juro.2013.01.084

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.