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.

Guidance for Developing Treatment
of BCG-Unresponsive NMIBC[6]

Three Different BCG-Unresponsive NMIBC Populations[6*]

* Figure represents document text

of patients experienced recurrence during BCG supply shortage
(n=211)
VS
of patients experienced recurrence when BCG supplies were adequate
(n=191)

Adequate BCG is defined as at least one of the following[6]:

  • At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy.
  • At least five of six doses of an initial induction course plus at least two of six doses of a second induction course

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 comorbidities7
  • Some patients are unwilling to undergo radical cystectomy due to concerns about significant life changes and potential complications8
*AUA guidelines include FDA-approved treatment options after BCG failure.9

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. Food and Drug Administration. BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment. Guidance for Industry (02-2018). 7. 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. 8. 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. 9. 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.

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