Abstract
Abstract only
e15021
Background: Regorafenib is a multi-kinase inhibitor that was FDA approved for the treatment of refractory advanced colorectal cancer. It has been found in the clinical trials to have modest benefit and relatively high toxicity, but the outcome of its routine use in the clinic practice is lacking. Our aim is to assess the outcome in our local clinic practice. Methods: Records of all colorectal cases who were treated with regorafenib were reviewed. Structured CRF was developed. Clinical, pathological and molecular data were collected. Efficacy and toxicity details were analyzed. Results: Thirty-two cases of metastatic colorectal cancer were treated with regorafenib from February 2014 to February 2016. All patients received prior oxaliplatin, irinotecan and bevacizumab based regimens, and cetuximab if wild type. Median age: 53.5 years. Male: 15 (46.9%). Primary tumor was right sided in 10 patients (31.3%), and left sided (including rectum) in 22 (68.7%). Pan RAS mutant: 21 (65.6%). Fifteen patients (46.9 %) had ECOG Performance Status of one, whereas 16 patients (50%) have ECOG 2. Starting dose was reduced to 120mg in 11 (34.4%). Only 5 (15.6%) continued beyond 3 cycles. 18 patients (56.3%) required dose reduction. Overall response: PR/CR: zero; Stable disease: 4 (12.5%); Progressive disease: 25 (78.1%); Clinical progression in 1 (3.1%), and 2 cases were not evaluated. After median follow up of 7 months, 22 patients (68.8%) have died, 5 (15.6%) are still alive and 5 (15.6%) are lost to follow up. Median survival: 9.3 months, and median PFS: 2.5 months. Conclusions: Regorafenib has poor tumor response in the routine clinic practice when given to patients with ECOG PS > 1. The median survival in this series is probably overestimated because of the relatively high rate of loss to follow up. Selection of patients is required in the routine clinic practice. Predictive markers are more important for such treatment with modest benefit, and significant toxicity and cost.