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Randomized placebo controlled phase II trial (MAJA): Efficacy results of maintenance vinflunine after cisplatin chemotherapy (CT) in patients with advanced urothelial carcinoma (UC). SOGUG 2011-02

Date

09 Oct 2016

Session

Poster display

Presenters

Begoña Pérez-Valderrama

Citation

Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373

Authors

B. Pérez-Valderrama1, A. Font Pous2, J.A. Virizuela Echaburu3, S. Hernando4, M.A. Climent5, J. Arranz Arija6, J.C. Villa Guzman7, M. Llorente8, N. Lainez Milagro9, B. Mellado10, A. González del Alba11, E. Gallardo12, D. Castellano13, U. Anido14, M. Domenech15, X. Garcia del Muro16, J. Puente17, R. Morales Barrera18, J. Bellmunt19, J. Garcia-Donas20

Author affiliations

  • 1 Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 2 Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona/ES
  • 3 Medical Oncology, Hospital Universitario Virgen Macarena, Sevilla/ES
  • 4 Medical Oncology, HUFA Hospital Universitario Fundacion Alcorcon, Alcorcon/ES
  • 5 Medical Oncology, Fundación Instituto Valenciano de Oncología, Valencia/ES
  • 6 Medical Oncology, Hospital General Universitario Gregorio Marañon, Madrid/ES
  • 7 Medical Oncology, Hospital General Ciudad Real, Ciudad Real/ES
  • 8 Medical Oncology Unit, Hospital General Universitario de Elda, 03600 - Alicante/ES
  • 9 Oncology, Complejo Hospitalario de Navarra, Pamplona/ES
  • 10 Medical Oncology, Hospital Clinic y Provincial de Barcelona, Barcelona/ES
  • 11 Medical Oncology, Hospital Universitario Son Espases, Palma de Mallorca/ES
  • 12 Medical Oncology, Hospital de Sabadell Corporacis Parc Tauli, Sabadell/ES
  • 13 Medical Oncology, University Hospital 12 De Octubre, Madrid/ES
  • 14 Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, Santiago de Compostela/ES
  • 15 Medical Oncology, Althaia - Xarxa Assitencial de Manresa, Manresa/ES
  • 16 Medical Oncology, Institut Català d'Oncologia Hospital Duran i Reynals, Barcelona/ES
  • 17 Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid/ES
  • 18 Medical Oncology, Vall d`Hebron University Hospital Institut d'Oncologia, Barcelona/ES
  • 19 Medical Oncology, University Hospital del Mar, Barcelona/ES
  • 20 Medical Oncology, Centro Integral Oncólogico Clara Campal, Madrid/ES
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Resources

Abstract 3555

Background

Vinflunine (VFL) is a microtubule inhibitor approved by EMA as treatment after platinum progressionin metastatic UC. We evaluated whether maintenance VFL delays progression after response to CT.

Methods

Patients (pts) with measurable disease, locally recurrent/metastatic UC and adequate organ functionwith radiological response or stabilization after 4-6cycles (cy) of a cisplatin/gemcitabine chemotherapy (carboplatinallowed after cy 4) were randomized (R) 1:1 to receive VFL 320 or 280mg/m2 (in case of PS1, age ≥75years, priorpelvic radiotherapy (RT) or CrCl 

Results

88pts from 21 institutions of SOGUG were R between 04/2012-01/2015. Forty five in the VFL arm and 43 inthe BSC arm. 1pt was not treated. 1 of 87 treated pts was not eligible due to an excess of time between the last doseof cisplatin and the start of VFL. At the beginning of treatment: median age 64years [42-83]; PS1 50%; Hb

Conclusions

Maintenance VFL significantly reduced the risk of disease progression in patients with metastaticdisease obtaining benefit from first line cisplatin-based CT. Treatment was well tolerated. Data is maturing to assessits impact in overall survival.

Clinical trial identification

EudraCT 2011-001271-39

Legal entity responsible for the study

SOGUG - Spanish Oncology GenitoUrinary Group

Funding

SOGUG - Spanish Oncology GenitoUrinary Group

Disclosure

All authors have declared no conflicts of interest.

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