5PSQ-066 Experience of use of axitinib in clinical practice

Background Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)−1, VEGFR-2 and VEGFR-3. These receptors are implicated in pathologic angiogenesis, tumour growth and metastatic progression of cancer. Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival. The safety and efficacy of axitinib were evaluated in a randomised, open-label, multicentre phase 3 study (AXIS). Progression-free survival (PFS) reported was 8.3 (95% CI: 6.7 to 9.2) months and median overall survival (OS) 20.1 (95% CI: 16.7 to 23.4) months. It was approved by the European Medicines Agency in 2012. It is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. Purpose To describe the effectiveness of axitinib in clinical practice, in terms of PFS and OS in patients with advanced RCC after failure of prior treatment with sunitinib or pazopanib. As a secondary endpoint, a clinical description of the sample was made. Material and methods Observational, retrospective and descriptive study. Data collection was performed in 2017. We included all patients treated with axitinib in a university hospital from December 2013 to 15 September 12 017. Primary endpoints were: PFS and OS, and other descriptive variables: first-line therapy, tumour histology, place of metastasis, hypertension diagnosed before or developed during the treatment and dose reductions. Data were assessed with SPSS v.23 software. Results Fourteen patients were treated in second-line therapy with axitinib. The PFS observed was 12 (95% CI: 8.9 to 15) months and median OS 20 (95% CI: 14.5 to 25.5) months. Ten patients received sunitinib as a first-line therapy and four pazopanib. Eleven (78.6%) showed clear cell histology tumours. Five (35.7%) patients presented visceral metastasis, six (42.9%) bone metastasis and three (21.4%) nervous central system. Five patients (35.7%) had arterial hypertension before axitinib treatment and two developed it during the treatment. Dose reduction was required in five patients due to adverse events (hypertension, proteinuria, diarrhoea and dysphonia). Two patients reached the objective dose of 10 mg twice daily. Conclusion Our data, although with a small sample, have shown that axitinib effectiveness is achieved as expected according to available data in the AXIS study. No conflict of interest