Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Cancer
Published in: BMC Cancer 1/2015

Open Access 01-12-2015 | Research article

Vinflunine in routine clinical practice for the treatment of advanced or metastatic urothelial cell carcinoma - data from a prospective, multicenter experience

Authors: Margitta Retz, Patrick de Geeter, Peter J. Goebell, Ullrich Matz, Wito de Schultz, Axel Hegele

Published in: BMC Cancer | Issue 1/2015

Login to get access

Abstract

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.
Literature
1.
von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000;18(17):3068–77.PubMed
2.
von der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23(21):4602–8.CrossRefPubMed
3.
Bellmunt J, Théodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol. 2009;27:4454–61.CrossRefPubMed
4.
Bellmunt J, Fougeray R, Rosenberg JE, von der Maase H, Schutz FA, Salhi Y, et al. Long-term survival results of a randomized phase III trial of vinflunine plus best supportive care versus best supportive care alone in advanced urothelial carcinoma patients after failure of platinum-based chemotherapy. Ann Oncol. 2013;6:1466–72.CrossRef
5.
Witjes JA, Compérat E, Cowan NC, De Santis M, Gakis G, Lebret T, et al. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol. 65(4):778–92
6.
American Joint Committee on Cancer (AJCC) (1983) Manual for staging of cancer, 2nd ed. (Beahrs OH, Myers MH, eds). Lippincott, Philadelphia.
7.
Sonpavde G, Pond GR, Fougeray R, Choueiri TK, Qu AQ, Vaughn DJ, et al. Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma: a retrospective analysis of pooled, prospective phase 2 trials. Eur Urol. 2013;63(4):717–23.CrossRefPubMed
8.
Vaughn DJ, Srinivas S, Stadler WM, Pili R, Petrylak D, Sternberg CN, et al. Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: results of a large phase 2 study. Cancer. 2009;18:4110–7.CrossRef
9.
Culine S, Theodore C, De Santis M, Bui B, Demkow T, Lorenz J, et al. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br J Cancer. 2006;10:1395–401.CrossRef
10.
Médioni J, Guillot A, Spaeth D, Di Palma C, Théodore. Historical data in real life from patients treated by vinflunine for an advanced or metastatic urothelial carcinoma: Results of the CURVE study. Eur J Cancer. 2013;49 Suppl 2:S647.
11.
Castellano D, Puente J, de Velasco G, Chirivella I, López-Criado P, Mohedano N, Fernández O, García-Carbonero I, González MB, Grande E: Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice. BMC Cancer. 2014;14:779.
12.
Hegele A, Goebell P, Matz U, Neuhaus T. 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. Urol Int. 2014;92(2):174–9.CrossRefPubMed
Metadata
Title
Vinflunine in routine clinical practice for the treatment of advanced or metastatic urothelial cell carcinoma - data from a prospective, multicenter experience
Authors
Margitta Retz
Patrick de Geeter
Peter J. Goebell
Ullrich Matz
Wito de Schultz
Axel Hegele
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-015-1434-3

Other articles of this Issue 1/2015

BMC Cancer 1/2015 Go to the issue

Research article

How do we estimate survival? External validation of a tool for survival estimation in patients with metastatic bone disease—decision analysis and comparison of three international patient populations

Research article

Epidemiology, clinical profile and treatment patterns of venous thromboembolism in cancer patients in Taiwan: a population-based study

Research article

Improved false negative rate of axillary status using sentinel lymph node biopsy and ultrasound-suspicious lymph node sampling in patients with early breast cancer

Case report

Bilateral Diffuse Uveal Melanocytic Proliferation (BDUMP) associated with B-cell lymphoma: report of a rare case

Research article

TLR3 expression correlates with apoptosis, proliferation and angiogenesis in hepatocellular carcinoma and predicts prognosis

Research article

Role of SMC1A overexpression as a predictor of poor prognosis in late stage colorectal cancer
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits