CP-136 Effectiveness and safety of axitinib in renal cell carcinoma

Background Agents targeting the vascular endothelial growth factor receptor (VEGF) pathway may induce many toxicities. The European Medicines Agency (EMA) recommended a starting dose of 5 mg twice daily in renal cell carcinoma. Purpose To describe the data regarding the effectiveness and safety of therapy with axitinib in patients with advanced renal cell carcinoma treated in our hospital. Material and methods Retrospective observational study that included all patients treated with axitinib until October 2015. The variables collected using electronic medical records were: sex, age, location of metastases, therapeutic positioning, ECOG Scale, initial dose, dosage adjustment, progression free survival (PFS), grounds for suspension-interruption and clinical variables associated with adverse effects. Results 26 patients were included, with a mean age of 64.55 years (±12.71); 54.85% were men. The diagnosis in 80.77% of patients was clear cell renal cell carcinoma, and metastatic lesions were located mainly in the lungs (69.23%), bones (53.85%), lymph nodes (38.46%) and liver (34.61%). The median number of lines of treatment was 3 (range 2–6). The median of the ECOG Scale was the same at the beginning and end of the study (ECOG=0). 64.54% of patients began treatment with a dose of 10 mg/day axitinib and median PFS was 11 months (95% confidence interval 6.673 to 15.327). Regarding the safety profile, 88.46% suffered an adverse reaction associated with axitinib, including: general disorders (60.87%), gastrointestinal (52.17%), vascular (47.82%) and skin (34.78%), increase in TSH (26.09%) and cardiac (17.39%). 19.23% of patients experienced dose reduction at some time during treatment due to drug intolerance and gastrointestinal upset (42.86%) being the main cause. Temporary interruption of treatment was observed in 57.69% of patients associated with axitinib, and 15.37% of treatments were suspended indefinitely because of side effects (one case with severe congestive heart failure and another with renal impairment). The rest of the suspensions were for clinical progression of the disease. Conclusion Only half of the patients began treatment at a dose of 10 mg/day, as recommended by the EMA. Median PFS in our patients was similar to that of clinical trials. Nearly 3 of 4 patients treated with axitinib experienced adverse effects that led to a temporary or permanent suspension of treatment. Therefore, the role of the pharmacist may be of special interest for the provision of special pharmaceutical care in drugs with a safety profile as relevant as axitinib. References and/or Acknowledgements Phase 3 AXIS trial. No conflict of interest.