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NON–MUSCLE INVASIVE BLADDER CANCER (NMIBC)
PATIENT EXPERIENCES

Explore these hypothetical patient experiences with Bacillus Calmette–Guérin (BCG) treatment shared in this section.

Rick, Age 72, BCG-unresponsive, Not an actual patient
Rick, age 72
Feeling uncertain about where his high-risk NMIBC treatment journey will lead him.
Not an actual patient.
Occupation: Owner of a textile factory
Lifestyle: Oversees business operations
Marital status: Married
Support: Wife and 2 sons are his caregivers

Rick is not responding to treatment with intravesical fluid BCG for his high-risk NMIBC. His urologist discussed the available treatment options with him, including BCG reinduction, alternative nonsurgical intravesical fluid therapies, systemic immunotherapy, and radical cystectomy (RC).1,2

  • Rick is concerned that his cancer is not responding to BCG and worries that he is to blame
  • Rick is feeling overwhelmed by the treatment options presented to him and wants to do everything he can to avoid RC. He cannot imagine the impact this will have on him and his family
  • He needs time to process before he is ready to share his concerns with his urologist

About BCG unresponsiveness

  • BCG-unresponsive disease is defined by ≥1 of the following3
    • Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG*
    • Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG
    • T1 high-grade disease at the first evaluation following an induction course of BCG
  • Historically, ~40% of patients with intermediate and HR-NMIBC, treated with BCG, developed recurrent disease4
    • Data are from a formal meta-analysis of 11 eligible studies conducted between 1987 and 2000 in 2,749 patients. CIS outcomes were only documented in 4 studies and the number of patients was too small for a formal analysis. Overall, the median follow-up was 26 months4
  • In patients with HR-NMIBC with CIS, treated with adequate BCG, the 5-year recurrence-free survival is ~25-80%5-7
    • Data were collected from 3 retrospective analyses: a multi-institutional review of 299 patients with BCG-unresponsive NMIBC treated at 10 academic institutions in the US, Canada, and France; an analysis of 386 patients with CIS of the bladder with or without associated pTa/pT1 disease treated with BCG between 2008 and 2015; a review of the records of 398 patients with NMIBC treated between 2001 and 20175-7
  • Treatment options after BCG unresponsiveness include BCG reinduction, other intravesical fluid instillations, systemic immunotherapy, or RC1,2
  • Many patients with BCG-unresponsive NMIBC are ineligible for (48%) or refuse RC (38%)8
    • Data from a retrospective chart review (January-May 2019) of 2,554 patients with BCG-unresponsive NMIBC, which included patients from various countries including 600 from the US8

CIS=carcinoma in situ; HR-NMIBC=high-risk non–muscle invasive bladder cancer.

*Adequate BCG is defined as receipt of at least 5 doses of the initial 6-dose induction course and at least 2 of 3 maintenance doses or at least 2 of 6 doses of the second induction course.3

References:

  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V7.2024. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed March 10, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

  2. Holzbeierlein JM, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO Guideline: 2024 amendment. J Urol. 2024;211(4):533-538. doi:10.1097/ju.0000000000003846

  3. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment guidance for industry. US Department of Health and Human Services. Food and Drug Administration. Published August 2024. Accessed February 9, 2025. https://www.fda.gov/media/101468/download

  4. Böhle A, Jocham D, Bock PR. Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol. 2003;169(1):90-95. doi:10.1016/S0022-5347(05)64043-8

  5. Ritch CR, Velasquez MC, Kwon D, et al. Use and validation of the AUA/SUO risk grouping for nonmuscle invasive bladder cancer in a contemporary cohort. J Urol. 2020;203(3):505-511. doi:10.1097/JU.0000000000000593

  6. Subiela JD, Rodríguez Faba Ó, Aumatell J, et al.Long-term recurrence and progression patterns in a contemporary series of patients with carcinoma in situ of the bladder with or without associated Ta/T1 disease treated with bacillus Calmette-Guérin: implications for risk-adapted follow-up. Eur Urol Focus. 2023;9(2):325-332. doi:10.1016/j.euf.2022.09.007

  7. Taylor J, Kamat AM, Annapureddy D, et al. Oncologic outcomes of sequential intravesical gemcitabine and docetaxel compared with bacillus Calmette-Guérin in patients with bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer. Eur Urol Focus. Published online December 17, 2024. doi:10.1016/j.euo.2024.12.005

  8. Chun DS, Broughton E, Gooden K, Mycock K, Rajkovic I, Taylor-Stokes G. Reasons for non-surgical management of patients with bacillus Calmette–Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). Poster presented at: 21st Annual Meeting Society of Urologic Oncology 2020; December 2-4, 2020.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

William, Age 72, BCG treatment interrupted, Not an actual patient
William, age 63
Went through three rounds of BCG and is responding, but had trouble with BCG shortages and holding in his treatment for the required time.
Not an actual patient.
Occupation: Retired construction worker
Lifestyle: Loves barbecuing with his family
Marital status: Widower
Support: Daughter is his caregiver

William is receiving BCG treatment for his high-risk NMIBC. He has an overactive bladder, which makes it difficult to “hold in” treatment.

  • He typically voids sooner than the recommended time. This creates constant worry that he’s wasting treatment and not receiving the full effect of each dose
    • William doesn’t share this with his urologist because he considers it private
  • William has also been affected by BCG shortages

Patient considerations

  • About 30-35% of patients aged 60+ have been estimated to have an overactive bladder1
  • Ongoing BCG shortages have led to patient prioritization, dose reductions, and rationing2,3
    • Based on supply and demand projections for 2022, there was a shortage of 150,000 BCG vials. This shortage would prevent more than 8,300 patients from receiving their full annual dose of treatment.4
  • In a retrospective cohort study of patients with high-risk NMIBC (N=139), those who received a lower dose of BCG due to potential supply issues were at greater risk when compared to those who received a full dose of BCG5
    • ~39% of patients who received a reduced dose of BCG developed bladder cancer recurrence within 1 year5
References:

  1. Coyne KS, Sexton CC, Bell JA, et al. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013;32(3):230-237. doi:10.1002/nau.22295

  2. Current drug shortages. American Society of Health-System Pharmacists. Accessed January 25, 2025. https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=All

  3. BCG shortage info. American Urological Association. Accessed February 5, 2025. https://www.auanet.org/about-us/bcg-shortage-info

  4. Implications of the national BCG drug shortage. End Drug Shortages Alliance. Published February 12, 2023. Accessed January 25, 2025.

  5. Ostrowski DA, Chelluri RR, Herzig M, et al. Diminished short-term efficacy of reduced-dose induction BCG in the treatment of non–muscle invasive bladder cancer. Cancers (Basel). 2023;15(14):3746. doi:10.3390/cancers15143746

Michelle, Age 44, BCG-responsive, Not an actual patient
Michelle, age 44
Currently responding to treatment but worries that if BCG stops working, she will be recommended for a radical cystectomy (RC).
Not an actual patient.
Occupation: Teacher
Lifestyle: Active social life
Marital status: Married with 3 children
Support: Her husband is her caregiver

Michelle is relieved that BCG is currently working for her, although she has read that BCG can stop working for some patients.

  • Her high-risk NMIBC diagnosis came as a shock to her. She is an atypical patient, as bladder cancer is more prevalent in older adults and is more common in males than females
  • Michelle thinks about the fact that radical cystectomy (RC) is often recommended for patients who don’t respond to treatment with BCG
    • While she knows that RC can be a life-saving surgery, it is also life-altering
    • She thinks about how this could affect her self-image, her relationship with her husband, how she spends time with her children, and her overall quality of life
  • She doesn’t express her anxiety to her urologist because she feels it wouldn’t change anything

Patient considerations

  • In the US, it is estimated that about 65,080 men and 19,790 women will be diagnosed with bladder cancer in 20251
  • The median age at bladder cancer diagnosis is 732
  • Historically, ~40% of patients with intermediate and HR-NMIBC, treated with BCG, developed recurrent disease3
    • Data are from a formal meta-analysis of 11 eligible studies conducted between 1987 and 2000 in 2,749 patients. CIS outcomes were only documented in 4 studies and the number of patients was too small for a formal analysis. Overall, the median follow-up was 26 months3
  • In patients with HR-NMIBC with CIS, treated with adequate BCG, the 5-year recurrence-free survival is ~25-80%4-6
    • Data were collected from 3 retrospective analyses: a multi-institutional review of 299 patients with BCG-unresponsive NMIBC treated at 10 academic institutions in the US, Canada, and France; an analysis of 386 patients with CIS of the bladder with or without associated pTa/pT1 disease treated with BCG between 2008 and 2015; a review of the records of 398 patients with NMIBC treated between 2001 and 20174-6
  • RC is currently recommended as a preferred option for patients who are unresponsive to BCG7,8
    • Many patients with BCG-unresponsive NMIBC are ineligible for (48%) or refuse RC (38%)9
    • Data are from a retrospective chart review (January-May 2019) of 2,554 patients with BCG-unresponsive NMIBC, which include patients from various countries, including 600 patients from the US9
  • Treatments for BCG unresponsiveness include systemic immunotherapy, BCG reinduction, and other intravesical fluid instillations7,10

CIS=carcinoma in situ; HR-NMIBC=high-risk non–muscle invasive bladder cancer.

References:

  1. Bladder cancer. American Cancer Society. Accessed January 29, 2025. https://www.cancer.org/cancer/types/bladder-cancer.html

  2. Cancer stat facts: bladder cancer. Surveillance, Epidemiology, and End Results Program. National Cancer Institute. Accessed February 12, 2025. https://seer.cancer.gov/statfacts/html/urinb.htm

  3. Böhle A, Jocham D, Bock PR. Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol. 2003;169(1):90-95. doi:10.1016/S0022-5347(05)64043-8

  4. Ritch CR, Velasquez MC, Kwon D, et al. Use and validation of the AUA/SUO risk grouping for nonmuscle invasive bladder cancer in a contemporary cohort. J Urol. 2020;203(3):505-511. doi:10.1097/JU.0000000000000593

  5. Subiela JD, Rodríguez Faba Ó, Aumatell J, et al. Long-term recurrence and progression patterns in a contemporary series of patients with carcinoma in situ of the bladder with or without associated Ta/T1 disease treated with bacillus Calmette-Guérin: implications for risk-adapted follow-up. Eur Urol Focus. 2023;9(2):325-332. doi:10.1016/j.euf.2022.09.007

  6. Taylor J, Kamat AM, Annapureddy D, et al. Oncologic outcomes of sequential intravesical gemcitabine and docetaxel compared with bacillus Calmette-Guérin in patients with bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer. Eur Urol Focus. Published online December 17, 2024. doi:10.1016/j.euo.2024.12.005

  7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V7.2024. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed March 10, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

  8. Aminoltejari K, Black PC. Radical cystectomy: a review of techniques, developments and controversies. Transl Androl Urol. 2020;9(6):3073-3081. doi:10.21037/tau.2020.03.23

  9. Chun DS, Broughton E, Gooden K, Mycock K, Rajkovic I, Taylor-Stokes G. Reasons for non-surgical management of patients with bacillus Calmette–Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). Poster presented at: 21st Annual Meeting Society of Urologic Oncology 2020; December 2-4, 2020.

  10. Holzbeierlein JM, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO Guideline: 2024 amendment. J Urol. 2024;211(4):533-538. doi:10.1097/ju.0000000000003846

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.