According to a new study published in the journal BMC Cancer, researchers in Spain have found that the safety and efficacy of vinflunine for the treatment of patients with metastatic transitional cell carcinoma of the urothelial tract (TCCU) following disease progression after one platinum-based therapy in clinical practice are similar to the results observed in the phase 3 study of vinflunine.
Vinflunine is a Vinca alkaloid microtubule inhibitor approved by the European Medicines Agency (EMA) as monotherapy for the treatment of patients with advanced or metastatic TCCU after failure of a prior platinum-containing therapy. The drug has not been approved in the United States.
For the study, researchers sought to investigate the use of vinflunine in clinical practice as there has been limited data outside of clinical trials. They assessed the use of vinflunine in 102 patients with metastatic TCCU who had a median age of 67 years. Researchers included patients with an ECOG performance status of 0-2.
Patients with an ECOG status of 2 had not been previously studied. Efficacy results showed a median progression-free survival of 3.9 months and an overall survival of 10 months. The clinical benefit rate was 65.7%. The most common adverse effects observed were constipation, vomiting, neutropenia, and abdominal pain.
Vinflunine for the treatment of metastatic TCCU similar to the results from phase 3 study.