Hand-foot skin reaction (HFSR) caused by regorafenib deteriorates the quality of life (QOL) of patients. Risk factors of HFSR by regorafenib in the Japanese population have not been clarified. We conducted a retrospective survey to clarify the risk factors of HFSR by regorafenib in 45 patients with unresectable advanced or recurrent colorectal cancer. The initial dose of regorafenib was reduced in 19 (42.2%) patients. The median time to treatment failure (TTF) was 42 days, and median relative dose intensity (RDI) was 50% over the entire treatment period. HFSR was developed in 31 patients (68.9%), and 22 of them (48.9%) were assessed as Grade 2 or higher.
In the Cox proportional hazards regression analysis, significantly prolonged factors of TTF by regorafenib were a history of three or more chemotherapy regimens (hazard ratio 0.484, 95% confidence interval: 0.247-0.948; P = 0.034) and HFSR assessed as Grade 2 or higher (hazard ratio 0.378, 95% confidence interval: 0.163-0.620; P = 0.001). In the multivariable logistic regression analysis, significant risk factors of severe HFSR assessed as Grade 2 or higher were under 65 years old (odds ratio 4.755, 95% confidence interval: 1.215-18.616; P = 0.025) and hypoalbuminemia (odds ratio 4.738, 95% confidence interval: 1.208-18.582; P = 0.026).
