796P - Randomized placebo controlled phase II trial (MAJA): Efficacy results of maintenance vinflunine after cisplatin chemotherapy (CT) in patients with...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Urothelial Cancers
Presenter 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
  • 1Medical Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 2Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona/ES
  • 3Medical Oncology, Hospital Universitario Virgen Macarena, Sevilla/ES
  • 4Medical Oncology, HUFA Hospital Universitario Fundacion Alcorcon, Alcorcon/ES
  • 5Medical Oncology, Fundación Instituto Valenciano de Oncología, Valencia/ES
  • 6Medical Oncology, Hospital General Universitario Gregorio Marañon, Madrid/ES
  • 7Medical Oncology, Hospital General Ciudad Real, Ciudad Real/ES
  • 8Medical Oncology Unit, Hospital General Universitario de Elda, 03600 - Alicante/ES
  • 9Oncology, Complejo Hospitalario de Navarra, Pamplona/ES
  • 10Medical Oncology, Hospital Clinic y Provincial de Barcelona, Barcelona/ES
  • 11Medical Oncology, Hospital Universitario Son Espases, Palma de Mallorca/ES
  • 12Medical Oncology, Hospital de Sabadell Corporacis Parc Tauli, Sabadell/ES
  • 13Medical Oncology, University Hospital 12 De Octubre, Madrid/ES
  • 14Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, Santiago de Compostela/ES
  • 15Medical Oncology, Althaia - Xarxa Assitencial de Manresa, Manresa/ES
  • 16Medical Oncology, Institut Català d'Oncologia Hospital Duran i Reynals, Barcelona/ES
  • 17Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid/ES
  • 18Medical Oncology, Vall d`Hebron University Hospital Institut d'Oncologia, Barcelona/ES
  • 19Medical Oncology, University Hospital del Mar, Barcelona/ES
  • 20Medical Oncology, Centro Integral Oncólogico Clara Campal, Madrid/ES

Abstract

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.