New Intravesical Agents for BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer.
BCG
bladder cancer
bladder instillations
intravesical instillations
non-muscle invasive bladder cancer
Journal
Bladder cancer (Amsterdam, Netherlands)
ISSN: 2352-3735
Titre abrégé: Bladder Cancer
Pays: Netherlands
ID NLM: 101668567
Informations de publication
Date de publication:
2023
2023
Historique:
received:
31
05
2023
accepted:
22
08
2023
medline:
12
7
2024
pubmed:
12
7
2024
entrez:
12
7
2024
Statut:
epublish
Résumé
With the exception of the FDA-approved valrubicin and pembrolizumab, there are no standard second-line treaments for BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC). To provide a systematic review of the novel intravesically administered therapeutic agents for the salvage treatment of BCG-unresponsive NMIBC. Online search of the PubMed, EMBASE and Web of Science databases was performed. The endpoints of this review were to evaluate the efficacy of the agents in terms of complete response rates (CR) and durability of CR, overall survival, recurrence-free survival and cancer-specific survival and to report on their toxicity profile. A search on Clinicaltrials.gov was performed to identify ongoing clinical trials. 14 studies were included in this review. The critical clinical need for the development of an effective, safe and durable intravesical drug for the salvage treatment of high-risk NMIBC seems to be met mainly by intravesical gene therapy; in fact, data support the FDA-approved nadofaragene firadenovec as a potentially important therapeutic advancement in this context. Promising results are also being obtained by the combination of N-803/BCG and by innovative drug delivery systems. Considering the plethora of novel intravesical treatments that have completed phase II evaluation, one can reasonably expect that clinicians will soon have at their disposal new agents and treatment options for BCG-unresponsive NMIBC. In the near future, it will be up to the urologist to identify, for each specific patient, the right agent to use, based on safety, results and cost-effectiveness.
Sections du résumé
BACKGROUND
BACKGROUND
With the exception of the FDA-approved valrubicin and pembrolizumab, there are no standard second-line treaments for BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC).
OBJECTIVES
OBJECTIVE
To provide a systematic review of the novel intravesically administered therapeutic agents for the salvage treatment of BCG-unresponsive NMIBC.
METHODS
METHODS
Online search of the PubMed, EMBASE and Web of Science databases was performed. The endpoints of this review were to evaluate the efficacy of the agents in terms of complete response rates (CR) and durability of CR, overall survival, recurrence-free survival and cancer-specific survival and to report on their toxicity profile. A search on Clinicaltrials.gov was performed to identify ongoing clinical trials.
RESULTS
RESULTS
14 studies were included in this review. The critical clinical need for the development of an effective, safe and durable intravesical drug for the salvage treatment of high-risk NMIBC seems to be met mainly by intravesical gene therapy; in fact, data support the FDA-approved nadofaragene firadenovec as a potentially important therapeutic advancement in this context. Promising results are also being obtained by the combination of N-803/BCG and by innovative drug delivery systems.
CONCLUSIONS
CONCLUSIONS
Considering the plethora of novel intravesical treatments that have completed phase II evaluation, one can reasonably expect that clinicians will soon have at their disposal new agents and treatment options for BCG-unresponsive NMIBC. In the near future, it will be up to the urologist to identify, for each specific patient, the right agent to use, based on safety, results and cost-effectiveness.
Identifiants
pubmed: 38993180
doi: 10.3233/BLC-230043
pii: BLC230043
pmc: PMC11181857
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Pagination
237-251Informations de copyright
© 2023 – The authors. Published by IOS Press.
Déclaration de conflit d'intérêts
A.D.A., M.K., G.C., O.F., F.H., M.R., A.G., P.G. have no conflicts of interest concerning the manuscript. G.G. is an Editorial Board Member of this journal, but was not involved in the peer-review process nor had access to any information regarding its peer-review.