AI Article Synopsis
- There is a need for alternative treatments in patients with non-muscle invasive bladder cancer (NMIBC) who do not respond to BCG therapy.
- An open-label study tested the effectiveness of intravesical gemcitabine in patients who had previously failed BCG, focusing on disease-free survival (DFS) and safety over a follow-up period of 27 months.
- Results indicated a DFS of 68.75% post-treatment, with manageable side effects, suggesting gemcitabine could be a viable treatment option for those avoiding radical cystectomy.
Article Abstract
Background: There is an unmet alternative medical therapy for BCG unresponsive patients.
Objective: To report efficacy of intravesical gemcitabine in NMIBC patients, who failed a previous course of BCG, or intolerant, and unwilling to undergo radical cystectomy (RC).
Material And Methods: This is an open-label, single-arm study, which enrolled patients showing a failure or were intolerant to BCG and unwilling to undergo the RC. Intravesical gemcitabine was administered once a week for six consecutive weeks and once a month for 12 months. The primary outcome was DFS defined as the lack of a tumor on cystoscopy and negative urine cytology. Secondary endpoint was safety defined according a grading of side effects. OS, PFS, and DFS were described with Kaplan-Meier method at 12 and 24 months.
Results And Limitations: Overall 36 patients were enrolled. The median follow-up was 27 months. The DFS was 68.75% at the end of induction phase and 44.44% and 31.66% at 12 and 24 months of, respectively. The PFS was 43.75%. The OS and CSS were 77.9% (95% CI 58.78%-88.92%) and 80.68% (95% CI 61.49%-90.96%), respectively. There was no life threatening event or treatment-related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (LUTS) and fatigue (G1-G2).
Conclusion: Patients who presented an unresponsive-BCG recurrent NMIBC and unwilling to receive a RC, could benefit from intravesical gemcitabine as salvage organ-sparing treatment.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8988784 | PMC |
| http://dx.doi.org/10.1002/bco2.28 | DOI Listing |
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