430P - GEINOFOTE: Safety and activity analysis of the use of fotemustine (FT) in different schedules in progressive glioblastoma (GB) in Spain

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Central Nervous System Malignancies
Presenter Pedro Perez Segura
Citation Annals of Oncology (2014) 25 (suppl_4): iv137-iv145. 10.1093/annonc/mdu330
Authors P. Perez Segura1, R.A. Manneh2, I. Ceballos3, A. Garcia Castaño4, M. Benavides5, J. Fuster6, J.M. Cano7, M.A. Vaz8, J.P. Berros9, M. Covela10, V. Moreno11, T. Quintanar12, J.M. Garcia-Bueno13, I. Fernandez Perez14, O. Gallego15, P. Ramirez Daffós16, J. Espinos Jimenez17, S. Gonzalez18, S. Del Barco19, S. Ros20
  • 1Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 2Medical Oncology, Hospital 12 de octubre, Madrid/ES
  • 3Medical Oncology, H U Canarias, Las Palmas de Gran Canaria/ES
  • 4Medical Oncology, Hospital Marqués de Valdecilla, Santander/ES
  • 5Medical Oncology, Hospital Carlos Haya, Málaga/ES
  • 6Medical Oncology, Hospital Son Espasses, Palma de Mallorca/ES
  • 7Medical Oncology, Hospital general de CiudadReal, Ciudad Real/ES
  • 8Medical Oncology, Hospital Ramón y Cajal, Madrid/ES
  • 9Medical Oncology, Hospital Central de Asturias, Oviedo/ES
  • 10Medcal Oncology, Hospital Lucus Augusti, Lugo/ES
  • 11Medical Oncology, Hospital La Paz, Madrid/ES
  • 12Medical Oncology, Hospital General de Elche, Elche/ES
  • 13Medical Oncology, Complejo Hospitalario Universitario de Albacete, Albacete/ES
  • 14Medical Oncology, Hospital Xeral Cies Vigo, Vigo/ES
  • 15Medical Oncology, Hospital Sant Pau, Barcelona/ES
  • 16Medical Oncology, Hospital Puerta del Mar, Cadiz/ES
  • 17Medical Oncology, Clinica Universitaria de Navarra, Pamplona/ES
  • 18Medical Oncology, Hospital Mutua Terrassa, Barcelona/ES
  • 19Medical Oncology, ICO, Gerona/ES
  • 20Medical Oncology, Hospital Virgen de la Arrixaca, Murcia/ES

Abstract

Aim

Previous studies showed that FT may be useful as treatment in recurrent GB. The present study evaluate the activity and toxicity of FT in recurrent malignant GB patients in the clinical setting in Spain.

Methods

Patients (age >18 years) with GB that was progressive (first or second recurrence) after prior standard radiotherapy plus temozolomide (TMZ) chemotherapy were eligible for the study. Patients were scheduled to receive FT in different schedules (Addeo vs others). Tumor response was assessed by MRI every 8-12 weeks. The primary end point was safety; secondary points included progression free survival (PFS), overall survival (OS). We analyze the differences between Addeo schedule (A) vs others (O) and 1° recurrence (1°R) vs 2° recurrence (2°R) in terms of safety and activity.

Results

84 patients were assessed; all of them began FT previously Nov 31, 2012. There were 46 males, and the median age was 56 years (ranged from 30 to 73). The median KPS was 70 (40-100). A schedule was used in 60 pts (71.4%). FT in first recurrence was used in 39 pts (46.2%) and 45 pts (51.2%) in second recurrence. The median PFS was (A 1°R / O 1°R/ A 2°R / O 2°R) 3.11/2.41/3.04/2.84 months, the median OS was (A 1°R / O1°R/ A 2° R / O 2°R) 6.15/5.29/4.36/3.87 months . The most common toxicities include thrombocytopenia and neutropenia. There were no statistical differences in Grade III or IV toxicities in relation with the type of schedule (A vs O) nor the 1° or 2° R (17%-7%). The patients received more frequent A schedule than O in 1°R or 2° R. No differences between A vs O in terms of clinical benefit, PS improve or less dexametasone use. Time to response: patients in A schedule spent less time to get the better response than patients with O schedules, whenever we use FT (no significant differences).

Conclusions

FT has modest activity for recurrent GB with acceptable toxicity, regardeless the type of schedule. Probably, A get better response in less time than O schedules.

Disclosure

All authors have declared no conflicts of interest.