Large-scale, prospective observational study of regorafenib in Japanese patients with advanced gastrointestinal stromal tumors in a real-world clinical setting

A large-scale, prospective observational study evaluated the safety and effectiveness of regorafenib in Japanese patients with GIST in a real-world clinical setting. Patients with GIST received oral regorafenib at a maximum daily dose of 160 mg for weeks 1–3 of each 4-week cycle. The primary objective was to assess significant adverse drug reactions (ADRs), the frequency of occurrence of ADRs, hand and foot syndrome, and discontinuation of treatment due to disease progression and adverse events.