theracys bcg

BCG for Urinary Bladder Cancer and BCG sepsis

The objectives of intravesical therapy in bladder cancer is to:

  1. avoid post-TURB (Transurethral resection of bladder) implantation of tumor cells
  2. eradicate residual disease
  3. prevent tumor recurrence
  4. delay or reduce tumor progression

Indications of BCG in bladder cancer:

  1. Intravesical treatment and prophylaxis ofย bladder CIS
  2. Prophylaxis of primary orย recurrent stage Ta and/or T1 papillary tumorsย following TUR

It is not recommended for Ta low-gradeย papillary tumors, unless they are judged to be at highย risk of recurrence.

Mechanism of action of BCG in bladder cancer:

bcg bladder cancer mechanism


bcg mechanism

Pre-requisites of Intravesical BCG:

Urine R/E and Urine cultures: Defer treatment until clearance if –

  • Leukocytes: 100 X 10^6/L
  • Bacterial growth or specific organism identified
  • Macroscopic hematuria

With UTI, BCG can cause BCG cystitis and the antibiotics administered for UTI can decrease the BCG efficacy as BCG bacilli are sensitive to wide range of antibiotics.

Dispensary:ย Powder 81 mg (TheraCys), 50 mg (Tice BCG) –ย both reconstituted to 50 mL volume

theracys bcg

Procedure:

  1. Under all aseptic conditions bladder is catheterized and urine is drained
  2. 50 ml suspension of intravesical BCG is instilled
  3. Following instillation, patient should lie prone for 15 minutes
  4. Then patient is allowed to move freely to ensure the drug has the opportunity to bathe all parts of the bladder mucosa. The drug needs to remain in the patientโ€™s bladder for at least 1 hour (to a maximum of 2 hours).
  5. At the end of 2 hours, have the patient void in a seated position for safety reasons.
  6. Instruct the patient to increase fluid intake in order to flush the bladder in the hours following BCG treatment.

Note: Do not administer less than 2 wk afterย resection; do not administer intravesical forms SQ orย IM.ย If TheraCys is administered within two weeks of either biopsy, TUR or traumatic bladder catheterization (associated with hematuria), a systemic BCG reaction is much more likely to occur.

Regimen:

1 vial prepared &ย instilled in bladder for 2 hr.

  • Induction: Repeat once/wk ร— 6 weeks
  • Maintenance: At 3, 6, 12, 18, & 24 months

Contraindications:

  1. Known hypersensitivity
  2. Immunosuppresion: risk of disseminated BCG infection
  3. History of systemic BCG reaction
  4. Concurrent febrile illness, UTI or macroscopic hematuria
  5. Active tuberculosis

Side effects:

  1. Hematuria
  2. Urinary frequency
  3. Dysuria
  4. Bacterial UTI
  5. BCG sepsis
  6. Malaise
  7. Fever,ย chills, pain, nausea/vomiting, anorexia

BCG sepsis:

BCG sepsis: Potentially life-threatening eventย secondary to intravasation of intravesical BCGย resulting in cardiovascular collapse and acuteย respiratory distress

  • Possible etiologies include hypersensitivityย reaction and bacterial sepsis

โ€œBCG-osisโ€ is a term used to refer to disseminatedย disease in patients treated with BCG

  • The lungs and liver are typically involved
  • Patients are usually hemodynamically stable

“Systemic BCG reaction” may be defined as the presence of any of the following signs, if no other etiologies for such signs are detectable: fever >39.5ยฐC for > or = 12 hours; fever >38.5ยฐC for > or = 48 hours; pneumonitis; hepatitis; other organ dysfunction outside of the genitourinary tract with granulomatous inflammation on biopsy; or the classical signs of sepsis, including circulatory collapse, acute respiratory distress, and disseminated intravascular coagulation.

Risk factors:

  1. Inadequate delay after transurethral instrumentationย (TURBT or bladder biopsy)
  2. Traumatic catheterization or gross hematuria at timeย of intravesical instillation

Treatment:

  1. If antitubercular therapy required, intravesical BCGย should be discontinued
  2. Mild/moderate symptoms including low-grade feversย <48 hr (BCG cystitis):
    • Analgesics
    • NSAIDs
    • +/โ€“ Fluoroquinolone:ย levofloxacin 500 mg/d
  3. Antitubercular medications should be initiated forย signs of sepsis or severe cystitis symptoms >48 hr
    • Typically isoniazid 300 mg/d and rifampinย 600 mg/d for 3โ€“6 mo
    • For solid organ involvement, ethambutolย 15 mg/kg/d added
    • BCG resistant to cycloserine and pyrazinamide
    • Prednisone 40 mg/d recommended for septicย shock or if hypersensitivity reaction suspected

References:

  1. 5 minutes Urology consult
  2. Intravesical Chemotherapy and BCG for the Treatment of Bladder Cancer: Evidence and Opinion (European Association of Urology)

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