A 12 versus 6-week course of bacillus Calmette-Guerin prophylaxis for the treatment of high risk superficial bladder cancer

J Urol. 1997 Feb;157(2):487-91.


Purpose: We examined the efficacy of a 12-week prophylactic course of bacillus Calmette-Guerin (BCG) on superficial bladder cancer.

Materials and methods: From August 1992 until July 1994, 70 evaluable patients 41 to 80 years old (mean age 68.5) with high risk transitional cell carcinoma of the bladder were prospectively randomized to a 12-week prophylactic course of BCG (group 2) versus a traditional 6-week course (group 1). Mean followup was 28 months.

Results: A 70% tumor-free rate (21 patients) and mean interval of 12.9 months to recurrence were achieved in group 2 compared to 55% (22 patients) and 12.3 months, respectively, in group 1. Group 2 patients had an overall longer disease-free survival, although no statistical significance was achieved. A subgroup of patients with stage Ta cancer in whom at least 1 tumor was resected 12 month before treatment showed the most benefit from long-term prophylactic treatment in terms of disease-free survival. Side effects were only slightly more prominent in group 2, rendering the longer course fairly acceptable.

Conclusions: Our findings suggest a difference for better overall results with the 12-week course of BCG. However, a larger number of patients are needed to demonstrate a statistically significant difference between the 2 groups.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adult
  • Aged
  • Aged, 80 and over
  • BCG Vaccine / administration & dosage*
  • Carcinoma, Transitional Cell / prevention & control*
  • Carcinoma, Transitional Cell / secondary
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / prevention & control*
  • Prospective Studies
  • Risk Factors
  • Time Factors
  • Urinary Bladder Neoplasms / pathology
  • Urinary Bladder Neoplasms / prevention & control*


  • Adjuvants, Immunologic
  • BCG Vaccine