849P - Real life efficacy and safety of axitinib (AXI) in patients with renal cell carcinoma (RCC): Results from the Spanish compassionate use program

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Renal Cell Cancer
Biological Therapy
Presenter Pablo Maroto
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors P. Maroto1, N. Lainez2, E. Esteban3, M. Espinosa4, M.J. Juan5, O. Etxaniz6, C. Suarez7, J.M. Sepúlveda8, G. Rubio9, J.A. Arranz Arija10, L. Jimenez11, M.I. Saez12, J. Puente13, I. Chirivella Gonzalez14, E. Gallardo15, J.M. Jurado16, J. Garcia-Donas17, M. López Brea18, M. Garrido19, D. Soto de Prado Y Otero20
  • 1Dept. Of Medical Oncology, Hospital de la Sta. Creu i St. Pau, ES-08025 - Barcelona/ES
  • 2Medical Oncology, Complejo Hospitalario de Navarra, Pamplona/ES
  • 3Oncology Department, Hospital Universitario Central de Asturias, 33006 - Oviedo/ES
  • 4Oncology, Hospital Universitario Virgen del Rocío, Sevilla/ES
  • 5Oncología Médica, Instituto Valenciano de Oncología, Valencia/ES
  • 6Medical Oncology, Catalan Institute of Oncology ICO Badalona Hospital Germans Trias i Pujol, Medical Oncology, 08916 - Badalona/ES
  • 7Oncology, Hospital Vall d'Hebron, Barcelona/ES
  • 8Medical Oncology, University Hospital 12 de Octubre, 28041 - Madrid/ES
  • 9Oncology, Hospital Universitario. Fundacion Jimenez Diaz. Universidad Autónoma de Madrid, 28040 - Madrid/ES
  • 10Servicio De Oncologia Medica, Hospital General Univ. Gregorio Marañon, 28007 - Madrid/ES
  • 11Medical Oncology, Institut Català d’Oncologia de l’Hospitalet de Llobregat (ICO), Barcelona., 08907 - Hospitalet de Llobregat/ES
  • 12Medical Oncology, Hospital Universitario Virgen de la Victoria, Malaga/ES
  • 13Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 14Serv. Hematologia Y Oncologia Medica, Hospital Clinico Universitario, 46010 - Valencia/ES
  • 15Oncologia Medica, Hospital de Sabadell Corporacis Parc Tauli, ES-08208 - Sabadell/ES
  • 16Oncology Department, Hospital Universitario Clínico San Cecilio, 18012 - Granada/ES
  • 17Madrid, Centro Integral Oncológico Clara Campal, Madrid/ES
  • 18Oncology, Hospital Universitario Marqués de Valdecilla, 39008 - Santander/ES
  • 19Medical Oncology, Hospital Universitario Severo Ochoa, Leganés/ES
  • 20Oncology, Hospital Clinico Universitario de Valladolid, Valladolid/ES



AXI is a vascular endothelial growth factor receptor tyrosin kinase inhibitor recently approved for the treatment of patients (pts) with RCC after failure of sunitinib or a cytokine. In a phase III study, AXI showed an improved progression free survival (PFS) compared to sorafenib after failure to one prior treatment.


A retrospective data collection of pts treated under the Spanish compassionate use program was carried out. The objective of the study was to analyze the efficacy and safety of AXI in the real life setting. The study was approved by the regulatory authorities.


From September 2011 to March 2014, a total of 225 pts from 45 centers were included, 73.3% were male and the median age was 55 years (range 29-86). 80% had clear cell RCC and 88.4% had prior nephrectomy. 47.6% received AXI in 2nd line, 29.8% in 3rd line and 24.7% in 4th or subsequent line. The starting dose was 5 mg/12h in 97.3% of pts, 13.1% had at least one dose titration and 16.4% a dose reduction, mainly due to toxicity. At present, 30.8% of the pts continue on treatment with AXI. The response rate (RR) was 24% with 41.5% of disease stabilization (SD). Median PFS for all pts was 4.86 months (95%CI 3.92-5.81). Median PFS for pts that received AXI in 2nd, 3rd, or 4th or further line was 3.45, 5.03 and 5.49 months respectively (p= 0.383). Patients that achieved a response had a longer PFS than those who achieved only SD with a PFS of 12.32 and 7.00 months respectively (p = 0.009). PFS was also analyzed for several patient subgroups:

Patient subgroup PFS (months) p value
Clear cell vs. non-clear cell 4.93 vs. 3.88 0.098
Prior nephrectomy vs. no nephrectomy 5.03 vs. 2.69 0.106
Age <65 vs. ≥65 5.03 vs. 3.45 0.322
PS 0-1 vs. PS ≥2 5.68 vs. 2.56 <0.001
No or mild renal impairment vs. moderate or severe renal impairment 4.60 vs. 4.90 0.484

Median overall survival (OS) for all pts was 9.63 months. 76.9% of pts developed at least one adverse event (AE). Most common AE were, all grades (grade 3-4): asthenia 52% (9.3%), diarrhea 30.6%(4.8%) and hypertension 30.1% (2.2%).


The overall PFS is similar to the one reported in the phase III trial in patients previously treated with sunitinib. These data confirm the efficacy and safety of AXI in an unselected population.


All authors have declared no conflicts of interest.