Sorafenib-Regorafenib Sequential Therapy in Japanese Patients with Unresectable Hepatocellular Carcinoma-Relative Dose Intensity and Post-Regorafenib Therapies in Real World Practice

Background: We aimed to explore the relative dose intensity (RDI) and post-regorafenib treatments in regorafenib therapy. Methods: The medical records of 38 patients treated with regorafenib between July 2017 and June 2019 at our institution were collected. The RDI of regorafenib for the first month (1M-RDI) was calculated. Results: The overall survival (OS) and progression-free survival (PFS) were 12.4 and 3.7 months. The objective response rate and disease control rate were 13.2% and 71.1%. The median total dose of regorafenib in the first month was 2080 mg (240-3360 mg), and the median 1M-RDI was 61.9% (7.1-100%). Patients with 1M-RDI >= 50% showed significantly longer OS and PFS than patients with 1M-RDI < 50% (HR 0.19, 95% CI 0.08-0.48, p = 0.0004 and HR 0.2, 95% CI 0.08-0.52, p = 0.0008). A 1M-RDI >= 50% (HR 0.18, 95% CI 0.06-0.55, p = 0.002) and hand-foot skin reaction (HR 0.03, 95% CI 0.008-0.16, p < 0.0001) were independently associated with OS. Post-regorafenib therapies were performed in 19 (86.4%) of 22 patients who had stopped regorafenib due to disease progression. Conclusion: A 1M-RDI >= 50% is clinically significant. Post-regorafenib therapies are commonly performed in real-world practice.