Bacillus Calmette-Guérin without maintenance therapy for high-risk non-muscle-invasive bladder cancer

Eur Urol. 2011 Jul;60(1):32-6. doi: 10.1016/j.eururo.2011.03.051. Epub 2011 Apr 9.

Abstract

Background: Bacillus Calmette-Guérin (BCG) is the standard intravesical treatment of high-risk noninvasive (Ta, T1, Tis) bladder cancer. Maintenance BCG is recommended for maximum efficacy.

Objective: We compared our results in a large cohort of high-risk bladder cancer patients who received BCG without maintenance with published results from randomized maintenance BCG trials.

Design, setting, and participants: A cohort of 1021 patients underwent restaging transurethral resection for high-risk (Ta, T1, Tis) bladder cancer.

Intervention: Patients received a 6-wk induction course of BCG therapy. Responding patients did not receive maintenance BCG. Relapsing patients were eligible for retreatment with BCG. All patients were followed for a minimum of 5 yr.

Measurements: End points were 5-yr tumor- and progression-free survival rates.

Results and limitations: Of 816 complete responders to induction BCG, 2- and 5-yr recurrence-free survival rates were 73% and 46%, respectively. The progression-free survival rate was 89%. Progression-free survival time was 56 mo (95% confidence interval, 55-58 mo). Thirty-two percent of the patients required another course of BCG therapy. We cannot exclude that maintenance BCG may benefit patients beyond 5 yr over induction BCG alone and selective BCG retreatments.

Conclusions: Our results with BCG treatment without maintenance of patients with high-risk non-muscle-invasive bladder cancer compare favorably with trials in which comparable patients received maintenance BCG.

Publication types

  • Comparative Study

MeSH terms

  • Adjuvants, Immunologic / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • BCG Vaccine / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Urinary Bladder Neoplasms / drug therapy*
  • Young Adult

Substances

  • Adjuvants, Immunologic
  • BCG Vaccine