Procedures
Cancer, tumour, hand-foot skin reaction
ADVERSE EVENT, HYPERTENSION, TUMOUR, CANCER
Regorafenib was orally administered at a dose of 120 mg per patient once daily after meals for 3 weeks (day 1–21), followed by a 1-week off-treatment period (day 22–28). This 4-week period was considered one cycle. Dose reduction or interruption was allowed during treatment based on the severity of the regorafenib-related AEs. Dose modification was initiated for AEs > grade 2, except for hand-foot skin reaction, hypertension, and increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin (T-Bil) (Supplementary Table If AEs ≥ grade 2 were not observed in cycle 1, a dose increase to 160 mg/day in cycle 2 and beyond was allowed. However, when only AEs ≥ grade 1 for AST, ALT, or bilirubin increases were newly observed, the regorafenib dose was not increased. Treatment continued until tumour progression, unacceptable side-effects, or withdrawal of consent occurred. Antitumor response was evaluated by each investigator every 8 weeks according to the RECIST guidelines. AEs were assessed by investigators and reported according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version 4.0)