Abstract 1307
Background
Regorafenib is a multi-kinase inhibitor that was approved for treatment of refractory advanced colorectal cancer. It has been found in clinical trials to have modest benefit and a relatively significant toxicity. Our aim was to assess the efficacy of regorafenib in our local clinic practice.
Methods
Records of all confirmed colorectal cancer cases who were treated with regorafenib were reviewed. Clinical, pathological and molecular data were collected. Efficacy and factors of possible prognostic significance were analysed.
Results
Seventy-eight patients with metastatic colorectal cancer were treated with regorafenib from February 2014 to February 2016 in 4 different institutions. Median age: 50.5 years. Male: 40 (51.3%). KRAS mutant: 41 (52%). Right colonic primary: 18 (23%). Fifty-two patients (66.7 %) have ECOG Performance Status 0-1, whereas 25 patients (32.1%) have performance status > 1. Fifty-eight patients (74%) had dose reduction. No patient achieved objective response, 15 patients (19%) achieved stable disease and 56 patients (72%) had progressive disease. With a median follow up of 6.5 months the median progression free survival was 2.8 months (95% CI 2.5-3.3) and overall survival was 8.0 months, (95% CI 6.2-9.7). Performance status of > 1 and absence of dose reduction had statistically significant impact on progression free survival (p = 0.0002 and 0.0012 respectively).
Conclusions
Regorafenib in clinical practice has equal efficacy to reported data from pivotal registration trials. Our data suggest that performance status and dose reduction are important prognostic factors in patients treated with regorafenib, suggesting careful patients’ selection. Predictive markers are important for such treatment with modest benefit, and significant toxicity and cost.
Editorial acknowledgement
Clinical trial identification
Legal entity responsible for the study
Shouki Bazarbashi, MBBS.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.