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.
Autor: Castellano, Daniel; Puente, Javier; De Velasco, Guillermo; Chirivella, Isabel; López-Criado, Pilar; Mohedano, Nicolás; Fernández, Ovidio; García-Carbonero, Icíar; González, María Belén; Grande-Pulido, E.
Resumen: 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.
Identificador universal: https://hdl.handle.net/10641/3839
Fecha: 2014
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