Apparent failure of current intravesical chemotherapy prophylaxis to influence the long-term course of superficial transitional cell carcinoma of the bladder

J Urol. 1995 May;153(5):1444-50.


During the 4 decades since the first introduction of intravesical chemotherapy, 3,899 patients were enrolled in 22 randomized prospective controlled studies. Of these 22 studies 13 reported a statistically significant benefit of intravesical chemotherapy. With varying followup, the reported decrease in the incidence of patients with tumor recurrence averaged only 14% (range -3 to +43%). Unfortunately, long-term (5-year) studies show no decrease in the incidence of recurrent tumor. Maintenance chemotherapy has failed to improve these results and data suggest that a single early postoperative instillation may, in fact, be most effective. Among 10 studies that include progression data none showed decreased tumor progression, and overall among 2,011 randomized patients progression occurred in 7.5% of those receiving intravesical chemotherapy and 6.9% of those treated by surgery alone. Since intravesical chemotherapy has been demonstrated in animal models to be carcinogenic, these data raise the concern that intravesical chemotherapy might possibly be carcinogenic in humans. In the absence of demonstrated long-term benefit we question the advisability of routine prophylactic intravesical chemotherapy.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Administration, Intravesical
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / therapeutic use
  • BCG Vaccine / administration & dosage
  • BCG Vaccine / therapeutic use
  • Carcinoma in Situ / epidemiology
  • Carcinoma in Situ / therapy
  • Carcinoma, Transitional Cell / drug therapy*
  • Carcinoma, Transitional Cell / epidemiology
  • Carcinoma, Transitional Cell / surgery
  • Follow-Up Studies
  • Humans
  • Incidence
  • Neoplasm Recurrence, Local / epidemiology*
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Treatment Failure
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / epidemiology
  • Urinary Bladder Neoplasms / surgery


  • Antineoplastic Agents
  • BCG Vaccine