Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice.
dc.contributor.author | Castellano, Daniel | |
dc.contributor.author | Puente, Javier | |
dc.contributor.author | De Velasco, Guillermo | |
dc.contributor.author | Chirivella, Isabel | |
dc.contributor.author | López-Criado, Pilar | |
dc.contributor.author | Mohedano, Nicolás | |
dc.contributor.author | Fernández, Ovidio | |
dc.contributor.author | García-Carbonero, Icíar | |
dc.contributor.author | González, María Belén | |
dc.contributor.author | Grande-Pulido, E. | |
dc.date.accessioned | 2024-01-30T09:44:30Z | |
dc.date.available | 2024-01-30T09:44:30Z | |
dc.date.issued | 2014 | |
dc.description.abstract | Background: Patients with transitional cell carcinoma of the urothelial tract (TCCU) who fail initial platinum-based chemotherapy for advanced disease represent a challenge in daily clinical practice. Vinflunine is approved by the European Medicine Agency (EMA) but, up to now, limited experience has been reported outside clinical trials. Methods: We assessed the efficacy and safety of vinflunine in an unselected group of 102 consecutive patients with metastatic TCCU. Results: The median age was 67 years (range 45–83). Among the most common comorbidities that patients presented at baseline were hypertension (50.5%) and diabetes (20.7%). Distant metastases were present in retroperitoneal nodes (58%), lung (29.3%), and bone (20.2%). The ECOG 0, 1 and 2 performance status at the start of vinflunine were 31.3%, 60.6% and 8.1%, respectively. The most commonly reported adverse events of any grade were constipation 70.6% (5.9% grade 3–4), vomiting 49.1% (2% grade 3–4), neutropenia 48.1% (12.8% grade 3–4) and abdominal pain 34.3% (4.9% grade 3–4). A median of 4 cycles of vinflunine was administered per patient (range 1–18). Median progression free and overall survival for all patients (N = 102) were 3.9 months (2.3-5.5) and 10 months (7.3-12.8), respectively. Time to tumor progression was 4.3 months (2.6-5.9). Two patients (2%) achieved CR, 23 (22.5%) patients had PR, and 42 (41.2%) presented SD as best response. The clinical benefit rate with vinflunine was 65.7%. Conclusions: Our results show that the behavior of vinflunine in routine clinical practice resembles that of the pivotal phase III randomized study. | spa |
dc.description.extent | 775 KB | spa |
dc.identifier.doi | 10.1186/1471-2407-14-779 | spa |
dc.identifier.issn | 1471-2407 | spa |
dc.identifier.uri | https://hdl.handle.net/10641/3839 | |
dc.language.iso | eng | spa |
dc.publisher | BMC Cancer | spa |
dc.relation.publisherversion | https://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-14-779 | spa |
dc.rights | Atribución-NoComercial-SinDerivadas 3.0 España | * |
dc.rights.accessRights | open access | spa |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.subject | Activity | spa |
dc.subject | Community setting | spa |
dc.subject | Second-line | spa |
dc.subject | Urothelial carcinoma | spa |
dc.subject | Vinflunine | spa |
dc.title | Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice. | spa |
dc.type | journal article | spa |
dc.type.hasVersion | AM | spa |
dspace.entity.type | Publication |
Files
Original bundle
1 - 1 of 1
Loading...
- Name:
- 1471-2407-14-779.pdf
- Size:
- 775.56 KB
- Format:
- Adobe Portable Document Format
- Description: