Background Regorafenib is an oral multi-kinase approved by the European Medicines Agency (EMA) for the treatment of metastatic colorectal cancer (mCRC) in patients who have failed treatment with fluoropyrimidine, oxaliplatin and irinotecan based chemotherapy, an anti-VEGF therapy and, if KRAS wild-type, an anti-EGFR therapy. Regorafenib showed improvement in median overall survival by 6 weeks and a clear increase in adverse events compared with placebo, based on data from the CORRECT trial. In our hospital, selection of patients was performed, restricting the use to patients with: status performance (ECOG=0), failed treatment with fluoropyrimidine, oxaliplatin and irinotecan based chemotherapy, an anti-VEGF therapy and, if KRAS wild type, an anti-EGFR therapy and patient survival expectancy >3 months.

Purpose The aim of this study was to analyse the effectiveness of regorafenib in the treatment of mCRC in a selected population per protocol compared with data from the CORRECT study.

Material and methods Retrospective observational study completed in 2015. All patients with mCRC receiving treatment with regorafenib in a tertiary hospital were included. Variables: demographics (age, sex), clinicals (KRAS wild-type, cycles of treatment, reduced dose, reported adverse events) and effectiveness (median duration of treatment). Information sources used were electronic records of medical history.

Results 10 patients were included with an average age of 55 years (70% men, 30% women). 30% of patients wre KRAS wild-type compared with 70% mutant, and 3.7 median lines of previous treatment had been given. Only two patient are in treatment. The need for reduced dose or temporary suspension was 80% (8/10). Median number of cycles was 2.5 (2–5), All patients scheduled for PET after 2 months of treatment showed disease progression. All patients experienced adverse events (AEs); 40% grade 3–4 (fatigue, hand-foot syndrome, diarrhoea). Not all observed adverse events were categorised in the clinical histories.

Conclusion The total percentage of adverse events was similar (90% vs 93) and inferior to the percentage of adverse events grades 3–4 (40 vs 54%) in our sample with respect to the CORRECT study. It seems that the selection of patients, in clinical practice, does not improve the results obtained in clinical trials. Therefore, we consider it necessary to closely monitor patients treated with regorafenib.

References and/or Acknowledgements

1. Grothey A. Lancet 2013;381:303-12

References and/or AcknowledgementsNo conflict of interest.