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2015 ; 15
(ä): 455
Nephropedia Template TP
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Vinflunine in routine clinical practice for the treatment of advanced or
metastatic urothelial cell carcinoma - data from a prospective, multicenter
experience
#MMPMID26040470
Retz M
; de Geeter P
; Goebell PJ
; Matz U
; de Schultz W
; Hegele A
BMC Cancer
2015[Jun]; 15
(ä): 455
PMID26040470
show ga
BACKGROUND: Vinflunine is recommended in the European guideline for the treatment
of advanced or metastatic urothelial cell carcinoma (UCC) after failure of
platinum-based therapy. METHODS: This prospective, non-interventional study
investigated the safety and efficacy of vinflunine in platinum-pretreated UCC
patients in routine clinical practice. Data were prospectively collected on
patients with advanced or metastatic UCC undergoing vinflunine treatment in 39
German hospitals and medical practices. Dosing of vinflunine, tumor assessments
and concomitant medications followed physician's routine clinical practice.
Primary endpoints were toxicity and assessment of vinflunine treatment
modalities. Secondary aims included overall response rate (ORR), overall survival
(OS) time and a prognostic risk-model. RESULTS: Seventy-seven platinum-pretreated
patients were recruited. Vinflunine was predominantly administered as second-line
(66%) therapy or in subsequent treatment lines (21%). One third of the patients
received at least six cycles of vinflunine and the average number was 4.7 cycles.
A vinflunine starting dose of 320 mg/m2 was chosen in 48% of patients and 280
mg/m2 in 39%. Grade 3/4 toxicities were leucopenia 16.9%, anemia 6.5%, elevated
liver enzymes 6.5% and constipation 5.2%. ORR was 23.4% and OS was 7.7 (CI 4.1 to
10.4) months. Patients with zero, one, two or??three risk factors displayed a
median OS of 18.2, 9.5, 4.1 and 2.8 months, respectively (p=0.0005; HR=1.82).
CONCLUSION: Vinflunine delivers a meaningful benefit to an unselected population
of advanced platinum-pretreated UCC patients managed in routine clinical
practice.