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 | Cytotoxic agents Renal Cell Cancer Therapy 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
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Abstract
Aim
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.
Methods
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.
Results
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%).
Conclusions
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.
Disclosure
All authors have declared no conflicts of interest.