Bacillus Calmette-Guérin (BCG) Refractory Non-Muscle-Invasive Bladder Cancer (NMIBC): Current Guidance and Experience
Angelo Naselli1, Giacomo Maria Pirola1, Daniele Castellani2
1San Giuseppe Hospital, IRCCS Multimedica, Multimedica Group, Milan, Italy.
Research and Reports in Urology
|November 18, 2024
Summary
For high-risk bladder cancer recurring after Bacillus Calmette-Guérin (BCG) therapy, new treatments beyond radical cystectomy are emerging. Research is exploring alternatives for BCG-unresponsive or refractory cases, offering hope for improved outcomes.
Area of Science:
- Urology
- Oncology
- Immunotherapy
Background:
- Bacillus Calmette-Guérin (BCG) is the standard treatment for high-risk, non-muscle invasive bladder cancer.
- Recurrence after BCG therapy necessitates further treatment, with classifications including BCG-naïve, BCG-exposed, and BCG-refractory (further divided into unresponsive and exposed).
- Current guidelines recommend radical cystectomy for BCG-unresponsive disease, but alternative options are being investigated.
Purpose of the Study:
- To review the definitions of BCG-refractory bladder cancer.
- To elucidate alternative treatment strategies to radical cystectomy for BCG-refractory bladder cancer, including approved and investigational therapies.
- To highlight recent advancements in the treatment landscape for recurrent high-risk bladder cancer.
Main Methods:
- Narrative review of existing literature.
- Analysis of definitions for BCG-refractory bladder cancer and its subcategories.
- Evaluation of alternative therapies to radical cystectomy, including systemic immunotherapy and gene therapy.
Main Results:
- BCG-refractory bladder cancer is categorized into unresponsive (recurrence within 1 year of BCG) and exposed.
- For BCG-naïve and exposed patients, further BCG cycles are standard, with radical cystectomy as an alternative.
- For BCG-unresponsive patients, radical cystectomy is preferred, but systemic immunotherapy (pembrolizumab) and gene therapy (nadofaragene firadenovec) show promise as alternatives, with outcomes potentially superior to intravesical agents.
- Limited data from Phase I/II studies exist for some novel therapies.
Conclusions:
- The field of bladder cancer treatment is evolving with new therapeutic options emerging.
- Alternative therapies to radical cystectomy, such as immunotherapy and gene therapy, are gaining traction for BCG-refractory bladder cancer.
- Further robust evidence is needed, but a clear direction for future treatments is established.
