According to the AUA/SUO guidelines, BCG is a recommended initial postsurgical treatment for high-grade T1 or high-risk Ta and newly diagnosed CIS 1

TURBT †, ‡

Ta

BCG

BCG reinduction

Cystectomy

T1

BCG

Cystectomy

CIS

BCG

BCG reinduction

Cystectomy

In a high-risk patient who is fit for surgery with persistent high-grade T1 disease on repeat resection, or T1 tumors with associated CIS, LVI, or variant histologies, initial radical cystectomy may be considered.
If patient is unwilling or unfit for cystectomy, alternative options are available according to AUA Expert Opinion.

Ongoing shortages of BCG correlate with increased recurrence2

  • Supply shortages of BCG have persisted for more than a decade, forcing urologists to ration doses and prioritize BCG for high-risk patients3,4

In a recent retrospective analysis*:

of patients experienced recurrence during BCG supply shortage
(n=211)
VS

of patients experienced recurrence when BCG supplies were adequate
(n=191)

of patients experienced recurrence during BCG supply shortage
(n=211)
VS
of patients experienced recurrence when BCG supplies were adequate
(n=191)
  • Primary endpoint: rate of tumor recurrence from 30 days after transurethral resection to the end of follow-up at 24 months
  • Relative risk: 0.7, 95% confidence interval [0.60, 0.82]; P<0.001

*Study group experiencing BCG shortage observed from October 2013 to December 2016; control group observed from November 2011 to September 2013.2

According to the AUA, the response to the BCG shortage has focused on BCG prioritization5

Low-Risk

BCG Is Not Recommended

Intermediate-Risk

BCG Is Not Recommended

  • Use intravesical chemotherapy as the first-line option.
High-Risk

BCG Is Recommended, at Full-Strength If Possible

  • If the full dose is not feasible, use 1/2 to 1/3 dose, and use 1/3 dose for maintenance (If supply exists for maintenance therapy for patients with NMIBC, limit dose to 1 year).
  • If BCG is not available, alternatives to BCG may also be considered with an induction and possible maintenance regimen.

AUA/SUO guidelines recommend cystectomy when BCG fails1*

After BCG, AUA recommends cystectomy for high-risk patients who are fit for surgery1

TURBT †, ‡

Ta

BCG

BCG reinduction

Cystectomy

T1

BCG

Cystectomy

CIS

BCG

BCG reinduction

Cystectomy

In a high-risk patient who is fit for surgery with persistent high-grade T1 disease on repeat resection, or T1 tumors with associated CIS, LVI, or variant histologies , initial radical cystectomy may be considered.
If patient is unwilling or unfit for cystectomy, alternative options are available according to AUA Expert Opinion.

Many patients are ineligible or unwilling to undergo cystectomy
  • Patients may be ineligible due to risk factors such as age, psychological state, nutritional status, cognitive status, and medical comorbidities6
  • Some patients are unwilling to undergo radical cystectomy due to concerns about significant life changes and potential complications7
*AUA guidelines include FDA-approved treatment options after BCG failure.8

For the treatment of NMIBC after BCG,

ADDITIONAL OPTIONS ARE NEEDED

>

For the treatment of NMIBC after BCG, ADDITIONAL OPTIONS ARE NEEDED >

References: 1. American Urological Association. (2020). Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Joint Guideline (2020). https://www.auanet.org//guidelines/bladder-cancer-non-muscle-invasive-guideline. 2. Ourfali S, Ohannessian R, Fassi-Fehri H, Pages A, Badet L, Colombel M. Recurrence rate and cost consequence of the shortage of bacillus Calmette-Guérin Connaught strain for bladder cancer patients. Eur Urol Focus. 2019. doi:101016/j.euf.2019.04.002. Accessed September 20, 2019. 3. Cernuschi T, Malvolti S, Nickels E, Friede M. Bacillus Calmette-Guérin (BCG) vaccine: a global assessment of demand and supply balance. Vaccine. 2018;36(4):498-506. 4. American Urological Association. (2020). BCG Shortage Info . https://www.auanet.org//about-us/bcg-shortage-info .5. American Urological Association. BCG Shortage Info. https://www.auanet.org/about-us/bcg-shortage-info. Accessed 10-21-2019. 6. Balar A, Bajorin DF, Milowsky MI. Management of invasive bladder cancer in patients who are not candidates for or decline cystectomy. Ther Adv Urol. 2011;3(3):107-117. 7. Garg T, Connors JN, Ladd IG, Bogaczyk TL, Larson SL. Defining priorities to improve patient experience in non-muscle invasive bladder cancer. Bladder Cancer. 2018;4(10):121-128. 8. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. https://www.auanet.org/guidelines/bladder-cancer-non-muscle-invasive-guideline. Accessed September 11, 2020. 9. Food and Drug Administration. BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment. Guidance for Industry (02-2018).

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