Monotherapy with intravenous vinflunine in patients with advanced or metastatic urothelial cancer after failure of a platinum-containing regimen: a retrospective analysis of German routine data.

Abstract

OBJECTIVE:

The objective of this retrospective study was to investigate the efficacy and safety of vinflunine monotherapy and the utility of second-line prognostic factors in patients with advanced or metastatic urothelial cancer relapsing/progressing during or after a prior platinum-containing regimen under daily routine clinical conditions in Germany.

METHODS:

The selection was based on the marketing authorization indication and recommendations as well as on the evaluation of second-line prognostic factors issued from prior pivotal trials.

RESULTS:

Eight centers across Germany provided a total of 21 patient records. Demographic and clinical characteristics were similar to the data previously reported in pivotal trials. Complete and partial response to vinflunine treatment was observed in 1 (4.8%) and 3 (14.3%) patients, respectively, resulting in an overall response rate of 19.1%. The disease control rate reached 47.7%. The median progression-free survival amounted to 4.4 months (95% CI 2.6-6.6), with a median overall survival of 6.2 months (95% CI 3.9-10.7). The observed toxicity profile was manageable and consistent with prior clinical trials: leukopenia (33.3%), neutropenia (9.5%), anemia (9.5%) and hyperglycemia (4.8%). The reported satisfaction rate with the treatment was 90.5 and 61.9% among patients and physicians, respectively.

CONCLUSIONS:

This retrospective study confirms that the clinical outcomes obtained from routine medical practice in Germany with vinflunine in the treatment of advanced/metastatic urothelial cancer are in line with the data observed in prior clinical trials.

• Authors: Axel Hegele, Peter Goebell, Ullrich Matz, Thomas Neuhaus
• Journal: Urologia internationalis (Urol Int) Vol. 92 Issue 2 Pg. 174-9 ( 2014) ISSN: 1423-0399 [Electronic] Switzerland
• PMID: 24334998 (Publication Type: Journal Article, Multicenter Study)
• Copyright: 2013 S. Karger AG, Basel.

Chemical References

• Antineoplastic Agents
• Platinum
• vinflunine
• Vinblastine

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage)
• Disease Progression
• Disease-Free Survival
• Female
• Germany
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Neoplasm Metastasis
• Platinum (administration & dosage)
• Prognosis
• Recurrence
• Retrospective Studies
• Risk
• Treatment Outcome
• Urinary Bladder Neoplasms (drug therapy, pathology)
• Urothelium (pathology)
• Vinblastine (administration & dosage, analogs & derivatives)