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

Hegele A, Goebell P, Matz U, Neuhaus T (2014)


Publication Type: Journal article

Publication year: 2014

Journal

Publisher: Karger

Book Volume: 92

Pages Range: 174-9

Journal Issue: 2

DOI: 10.1159/000354751

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. © 2013 S. Karger AG, Basel.

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APA:

Hegele, A., Goebell, P., Matz, U., & Neuhaus, T. (2014). 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. Urologia Internationalis, 92(2), 174-9. https://doi.org/10.1159/000354751

MLA:

Hegele, Axel, et al. "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." Urologia Internationalis 92.2 (2014): 174-9.

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