Bacillus Calmette-Guerin (BCG) immunotherapy for bladder cancer: review of complications and their treatment

Aust N Z J Surg. 1998 May;68(5):340-4. doi: 10.1111/j.1445-2197.1998.tb04768.x.


Background: Intravesical bacillus Calmette-Guerin (BCG) is widely used in the management of bladder cancer but because it is a living organism, local and disseminated infection may result.

Methods: A prospective assessment of complications of this therapy in 200 patients in Queensland was performed. A review of management of complications of intravesical BCG was also carried out.

Results: Major side effects were rare. Cystitis was the most common side effect, being seen to some degree in all patients, although only forcing cessation of BCG therapy in two patients. Two patients developed persistent cystitis necessitating institution of isoniazid and rifampicin. Two patients had culture-proven bladder infection that presented several months after the BCG treatment. These patients also responded to two-drug antituberculous therapy. While low-grade fever is very common with this therapy, seven patients (3.5%) had fevers of > 39 degrees C within 48 h of receiving BCG. Fevers may be an indication of severe disseminated mycobacterial infection, which has a high mortality, so it needs to be treated aggressively. Alternatively bacterial sepsis with gram-negative bacterial pathogens or a hypersensitivity reaction to BCG may cause this degree of fever, and cannot be rapidly distinguished from fulminant mycobacterial infection. One patient in the present series developed pneumonia attributed to mycobacterial dissemination.

Conclusions: The key to appropriate management of complications of BCG therapy is awareness of their possibility, even months or years after the therapy has been given. Appropriate empirical therapy in acute situations and mycobacterial culture in chronic situations can then be performed.

MeSH terms

  • Administration, Intravesical
  • Aged
  • Aged, 80 and over
  • Amoxicillin / administration & dosage
  • Antitubercular Agents / administration & dosage
  • BCG Vaccine / administration & dosage
  • BCG Vaccine / adverse effects*
  • Carcinoma, Transitional Cell / therapy*
  • Cystitis / drug therapy
  • Cystitis / etiology*
  • Cystitis / prevention & control
  • Drug Therapy, Combination / administration & dosage
  • Female
  • Fever / etiology
  • Gentamicins / administration & dosage
  • Humans
  • Immunotherapy / adverse effects*
  • Isoniazid / administration & dosage
  • Male
  • Middle Aged
  • Prospective Studies
  • Rifampin / administration & dosage
  • Urinary Bladder Neoplasms / therapy*
  • Urinary Tract Infections / drug therapy
  • Urinary Tract Infections / etiology


  • Antitubercular Agents
  • BCG Vaccine
  • Gentamicins
  • Amoxicillin
  • Isoniazid
  • Rifampin