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Efficacy and safety of dose-dense gemcitabine plus cisplatin as neoadjuvant chemotherapy for muscle-invasive bladder cancer.
- Source :
-
International journal of urology : official journal of the Japanese Urological Association [Int J Urol] 2024 Oct; Vol. 31 (10), pp. 1102-1106. Date of Electronic Publication: 2024 Jul 03. - Publication Year :
- 2024
-
Abstract
- Objective: The objective of this study was to evaluate the efficacy and safety of dose-dense gemcitabine and cisplatin (ddGC) as neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC).<br />Methods: Patients with locally advanced MIBC (cT2aN0M0-cT4N1M0) who received ddGC between December 2017 and December 2023 were included. Regimens of ddGC with pegfilgrastim were administered every 2 weeks for 4 cycles, followed by radical cystectomy. The pathological complete response (CR) (pT0N0) and objective response (OR) (<pT2N0) rates were evaluated in patients who underwent radical cystectomy. Tolerability was assessed using relative dose intensity (RDI). Adverse events (AEs) were documented according to the Common Terminology Criteria for Adverse Events in all patients who received ddGC. Disease-free survival (DFS) and overall survival (OS) were estimated using the Kaplan-Meier method.<br />Results: A total of 45 patients (cT2N0, 60%; cT3N0, 22%; cT4N0, 9%; and cTanyN1, 9%) were included. Of the 41 who underwent cystectomy, 38 (92.7%) completed all planned cycles, with a median RDI of 0.96 (interquartile range [IQR], 0.89-1.00). Overall, CR and OR were achieved in 12 (29.3%) and 17 (41.5%) patients, respectively, increasing to 32.4% and 45.9%, respectively, in cN0 patients. Severe AEs (grade ≥ 3) were observed in eight patients (17.8%), including four hematological toxicities. At a median follow-up of 31 months, 2-year DFS and OS were 70.8% and 89.2%, respectively.<br />Conclusion: Neoadjuvant ddGC demonstrated good tolerability, efficacy, and safety, suggesting its potential as a treatment option for MIBC.<br /> (© 2024 The Japanese Urological Association.)
- Subjects :
- Humans
Male
Female
Aged
Middle Aged
Retrospective Studies
Treatment Outcome
Disease-Free Survival
Chemotherapy, Adjuvant methods
Chemotherapy, Adjuvant adverse effects
Filgrastim administration & dosage
Filgrastim adverse effects
Adult
Polyethylene Glycols
Urinary Bladder Neoplasms drug therapy
Urinary Bladder Neoplasms pathology
Urinary Bladder Neoplasms surgery
Urinary Bladder Neoplasms mortality
Gemcitabine
Deoxycytidine analogs & derivatives
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Cisplatin administration & dosage
Cisplatin adverse effects
Neoadjuvant Therapy methods
Neoadjuvant Therapy adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Cystectomy
Neoplasm Invasiveness
Subjects
Details
- Language :
- English
- ISSN :
- 1442-2042
- Volume :
- 31
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- International journal of urology : official journal of the Japanese Urological Association
- Publication Type :
- Academic Journal
- Accession number :
- 38961545
- Full Text :
- https://doi.org/10.1111/iju.15524