Toxicity and early outcomes of regorafenib in multiply pre-treated metastatic colorectal adenocarcinoma-experience from a tertiary cancer centre in India

Regorafenib is a multikinase inhibitor (MKI) approved for use in multiply pre-treated metastatic colorectal cancers (mCRC). To the best of our knowledge, this is the first report of regorafenib from India.Records of 23 cases treated with regorafenib at our centre between June 2013 till September 2015 were reviewed. All had received at least two non cross resistant lines of therapy prior to regorafenib. Toxicity was recorded using CTCAE version 4.03. Responses were assessed using RECIST 1.1 criteria. Response evaluation was done every three months or earlier if clinically indicated. Five patients were still on therapy at the time of this report.The median age was 50 years. Thirty-nine percent (9/23) had upfront metastatic disease. Twenty-six percent (6/23) and 39% (9/23) patients had received prior treatment with cetuximab and bevacizumab respectively. Mean duration of regorafenib treatment was 3.8 months. At least one grade III/IV toxicity was noted in 65% (15/23) cases. The most common were handfoot syndrome (HFS) and fatigue seen in 86.9% (20/23) patients. Grade II and III HFS was seen in 65% patients. One patient required stoppage of treatment due to grade III hepatotoxicity. Dose reduction was required for 86.9% (20/23) patients. Best response noted was stable disease in 34.8% (8/23), partial response in 8.7% (2/23) patients and progression in 56.5% (13/23). Median progression free survival was 3 months and median follow-up was 4.5 months.Regorafenib, although an effective treatment strategy in multiply pre-treated mCRC, is associated with significant side effects.