Abstract
BackgroundPatients 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.MethodsWe assessed the efficacy and safety of vinflunine in an unselected group of 102 consecutive patients with metastatic TCCU.ResultsThe 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%.ConclusionsOur results show that the behavior of vinflunine in routine clinical practice resembles that of the pivotal phase III randomized study.
Highlights
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
One hundred and two metastatic TCCU patients who had previously failed one prior platinum-containing systemic therapy were treated with vinflunine as a single agent in a second-line setting
Our study demonstrates that vinflunine is an active and safe drug for patients with platinum-resistant urothelial carcinomas treated in routine daily practice
Summary
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. Transitional cell cancer of the urothelial tract (TCCU) represents a major health problem worldwide. Advanced TCCUs have been considered chemosensitive tumors based on high radiological response rates of 40-70% with cisplatin-based schemes such as gemcitabine-cisplatin (GC), methotrexate, In the last decade, wide ranges of single agents or combination schemes have been tested for activity in patients who are resistant to previous platinum approaches. Despite the great efforts and resources devoted to all these trials, together with the number of patients involved, in most cases the clinical outcomes were disappointing with objective response rates ranging between 10 and 20%, median progression free survivals of 2–3 months, and median overall survivals of 6–9 months [28]
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