Bladder cancer

Management of BCG-pretreated (very) high-risk NMIBC

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Освітня мета: Choose the most appropriate treatment for patients with (very) high-risk non-muscle-invasive bladder cancer (NMIBC) pretreated with bacillus Calmette-Guérin (BCG) based on response to BCG and individual and tumour characteristics.
Спеціальність: Urology, Medical oncology, Clinical oncology
Цільова аудиторія: Specialists (CME: basic, intermediate), Residents (senior)
Останнє оновлення: February 2025
Фон:

The EAU guidelines define BCG failure as any high-grade (HG) disease occurring during or after BCG therapy (non-HG recurrences are NOT considered BCG failure) [1]. For the definition of BCG failure sub-categories, the EAU guidelines refer to the International Bladder Cancer Group consensus statement on clinical trial design for patients with BCG-exposed high-risk NMIBC [2].

EAU guidelines definition of BCG failure [1]

CIS: carcinoma in situ.

Adequate BCG treatment is defined as [1]:

  • completion of at least 5 doses out of 6 of initial induction course and
  • at least 2 doses out of 6 of second induction course or 2 doses out of 3 of maintenance therapy.

The NCCN guidelines refer to the recommendations on appropriate clinical trial designs in NMIBC by the International Bladder Cancer Group for the definition of BCG-unresponsive tumours [3,4]:

  • BCG refractory if persistent HG disease at 6 months despite adequate BCG, including any stage or grade progression by 3 months after the first BCG cycle (i.e., HG T1 at 3 months after initial Ta, T1, HG disease, or CIS)
  • BCG relapsing if HG disease after achieving a disease-free state at 6 months after adequate BCG.

 

Regulatory approval status of drugs/medical devices included in this topic (indications limited to the NMIBC setting, status 12 February 2025)

 

 

  1. Gontero P, Birtle A, Compérat E, et al. European Association of Urology (EAU) guidelines on non-muscle-invasive bladder cancer (TaT1 and CIS). Update April 2024. Available at: https://uroweb.org/guideline/non-muscle-invasive-bladder-cancer/
  2. Roumiguié M, Kamat AM, Bivalacqua TJ, et al. Eur Urol 2022;82:34-46. PubMed 
  3. Flaig TW, Spiess PE, Abern M, et al. National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology: bladder cancer. Version 6.2024. Available at: https://www.nccn.org/guidelines/category_1
  4. Kamat AM, Sylvester RJ, Böhle A, et al. J Clin Oncol 2016;34:1935-44. PubMed 
  5. Press release of 27 January 2025 https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-european-medicines-agency-acceptance?field_nir_news_date_value%5bmin%5d=
  6. Press release of 4 December 2023 https://www.jnj.com/media-center/press-releases/johnson-johnsons-investigational-tar-200-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer
  7. Press release of 15 January 2025 https://www.jnj.com/media-center/press-releases/new-drug-application-initiated-with-u-s-fda-for-tar-200-the-first-and-only-intravesical-drug-releasing-system-for-patients-with-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer