CP-090 Evaluation of efficacy and safety of REGORAFENIB in metastatic colon cancer

Background Treatment with regorafenib is an alternative thirdline therapy for patients with metastatic colon cancer. This new treatment option was marketed in 2013, so it should be checked if the efficacy and safety in routine clinical practice are equivalent to those reported in pivotal trials. Purpose To assess the efficacy and safety of regorafenib in the treatment of metastatic colon cancer in routine clinical practice in a tertiary hospital. Material and methods This was an observational, descriptive, retrospective study. All patients with metastatic colon cancer treated with regorafenib until June 2016 were included. Data were recorded from computerised clinical history and pharmaceutical dispensing software. The following variables were collected: age, gender, therapeutic indication, overall survival(OS), progression free survival(PFS), adverse reactions and dose reduction. The primary efficacy endpoint was OS and the secondary efficacy endpoint was PFS. For safety profile assessment, adverse reactions were studied. Results 10 patients, 6 (60%) men and 4 (40%) women, were studied. Mean age was 60.8 years. All patients were diagnosed with metastatic colon cancer. Mean OS was 5.25 months and mean PFS was 2.55 months. Notified adverse reactions were: hand–foot syndrome (4), diarrhoea (2), asthenia (6), decreased intake (4), mucositis (2) and emetic syndrome (2). All patients had at least one adverse event and 80% required a full dose reduction for toxicity and/or poor tolerance. Conclusion The results of this efficacy study of regorafenib in metastatic colon cancer therapy in routine clinical practice were inferior to those reported in pivotal trials (6.4 months OS in CORRECT or 8.8 months in CONCUR vs 5.25 months). The safety profile was similar to that described in the data sheet but the frequency of patients requiring dose reduction (80%) was higher than expected. In conclusion, comparing the efficacy of older alternatives (regorafenib PFS 1.9 months, panitumumab PFS 1.9 months, cetuximab PFS 3.7 months, best supportive care PFS 1.2 months), the use of an alternative in thirdline treatment for metastatic colon cancer should be based on its safety profile and patient tolerance. No conflict of interest