Intravesical administration of bacillus Calmette-Guérin in patients with recurrent superficial carcinoma of the urinary bladder: report of a prospective, randomized trial

Cancer Treat Rep. 1985 Jan;69(1):47-53.


In an attempt to prevent, delay, or reduce further tumor occurrence, 88 patients with recurrent, superficial carcinoma of the urinary bladder were randomly assigned to receive either standard therapy (cystoscopy with fulguration) or standard therapy and bacillus Calmette-Guérin (BCG). BCG was administered intravesically and percutaneously once weekly for 6 weeks. No serious toxicity was seen. There were 43 evaluable patients in each of the two groups. Results in the BCG group versus the control group were as follows: reduction in the number of recurrent tumors (43 vs 27 patients [P less than 0.001] ); conversion to negative cytology (11 of 33 vs three of 34 patients [P less than 0.05] ); and tumor progression requiring cystectomy (three vs 15 patients [P less than 0.001] ). Disease-free interval (P less than 0.001), time with negative cytology (P less than 0.001), and time to progression of disease (P less than 0.003) were longer in patients treated with BCG. These results indicate that the combination of standard therapy and BCG is more effective than standard therapy alone in patients with recurrent superficial bladder tumors.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • BCG Vaccine / administration & dosage
  • BCG Vaccine / adverse effects
  • BCG Vaccine / therapeutic use*
  • Carcinoma in Situ / immunology
  • Carcinoma in Situ / therapy
  • Carcinoma, Papillary / immunology
  • Carcinoma, Papillary / therapy
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Female
  • Fever / etiology
  • Follow-Up Studies
  • Humans
  • Hydronephrosis / etiology
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / immunology
  • Neoplasm Recurrence, Local / therapy*
  • Papilloma / immunology
  • Papilloma / therapy
  • Prospective Studies
  • Prostatitis / etiology
  • Random Allocation
  • Skin Tests
  • Urinary Bladder Neoplasms / immunology
  • Urinary Bladder Neoplasms / therapy*


  • BCG Vaccine