What are the AUA-SUO guidelines for the use of Bacillus Calmette-Guérin (BCG) immunotherapy to treat non-muscle invasive bladder cancer?

Updated: Nov 12, 2019
  • Author: Gary David Steinberg, MD, FACS; Chief Editor: Bradley Fields Schwartz, DO, FACS  more...
  • Print
Answer

Answer

A 2016 guideline from the American Urological Association (AUA) and the Society of Urologic Oncology (SUO) includes the following recommendations for use of BCG in non–muscle invasive bladder cancer [2]

  • In a high-risk patient with newly diagnosed CIS, high-grade T1, or high-risk Ta urothelial carcinoma, administer a 6-week induction course of BCG (strong recommendation; evidence strength, grade B)
  • In an intermediate-risk patient who completely responds to an induction course of intravesical chemotherapy, maintenance BCG therapy may be used (conditional recommendation; evidence strength, grade C)
  • In an intermediate-risk patient who completely responds to induction BCG, consider maintenance BCG for 1 year, as tolerated (moderate recommendation; evidence strength, grade C)
  • In a high-risk patient who completely responds to induction BCG, maintenance BCG should be continued for 3 years, as tolerated (moderate recommendation; evidence strength, grade B)
  • In an intermediate- or high-risk patient with persistent or recurrent disease or positive cytology following intravesical therapy, consider performing prostatic urethral biopsy and an upper tract evaluation prior to administering additional intravesical therapy (conditional recommendation, evidence strength, grade C)
  • In an intermediate- or high-risk patient with persistent or recurrent Ta or CIS disease after a single course of induction intravesical BCG, a second course of BCG should be offered (moderate recommendation, evidence strength, grade C)
  • In a patient fit for surgery with high-grade T1 disease after a single course of induction intravesical BCG, radical cystectomy should be offered (moderate recommendation, evidence strength, grade C)
  • Additional BCG should not be prescribed to a patient who is intolerant of BCG or has documented recurrence on transurethral resection of bladder tumor (TURBT) of high-grade, non–muscle-invasive disease and/or CIS within 6 months of two induction courses of BCG or induction BCG plus maintenance (moderate recommendation, evidence strength, grade C)
  • If intermediate- or high-risk non–muscle-invasive bladder cancer persists or recurs after two courses of BCG and the patient is unwilling to undergo cystectomy or is unfit for it, clinical trial enrollment may be recommended; if a trial is unavailable, the patient may be offered intravesical chemotherapy (expert opinion)
  • In a high-risk patient with persistent or recurrent disease within 1 year following treatment with two induction cycles of BCG or BCG maintenance, radical cystectomy should be offered (moderate recommendation, evidence strength, grade C)

There has been an ongoing shortage of BCG in the United States, so in concert with other groups, the AUA and the SUO have issued a notice outlining strategies to maximize care for patients with non–muscle-invasive bladder cancer, including alternatives to BCG. Similarly, National Comprehensive Cancer Network (NCCN) bladder cancer guidelines acknowledge the BCG shortage, offer strategies to prioritize use of intravesical BCG, and identify alternative treatment approaches for some patients with non–muscle invasive bladder cancer. [3] NCCN recommendations for induction therapy with BCG include the following:

  • In the event of a BCG shortage, BCG should be prioritized for induction of high-risk patients (eg, high-grade T1 and carcinoma in situ [CIS]).
  • If feasible, the dose of BCG may be split (1/3 or 1/2 dose) so that multiple patients may be treated with a single vial in the event of a shortage.
  • Intravesical BCG therapy is initiated 3–4 weeks after TURBT with or without maintenance.
  • Weekly instillations during induction are given for approximately 6 weeks.
  • Maximum of 2 consecutive cycle inductions without complete response.
  • Withhold BCG in the event of traumatic catheterization, bacteriuria, persistent gross hematuria, persistent severe local symptoms, or systemic symptoms.

Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!