• Kun-Huei Yeh, Tsai-Sheng Yang, Tzu-Chi Hsu, Tzu-Liang ChenWilliamWDepartment of Surgery, China Medical University Hospital, Taichung, Taiwan., Hong-Hwa Chen, Hao-Wei Teng, Bo-Wen Lin, Feng-Che Kuan, Feng-Fan Chiang, Chi-Wei Duann, Ying-Shiuan Li, Meng-Ting Lin, Sabine Fiala-Buskies, Michel Ducreux, and Jaw-Yuan Wang.
• Department of Medical Oncology, National Taiwan University Cancer Center, and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
• J Formos Med Assoc. 2021 Nov 1; 120 (11): 2023-2031.

Background/PurposeThis analysis reports safety and effectiveness data from the Taiwanese cohort of the CORRELATE study.MethodsCORRELATE was a prospective, observational study to assess the safety and effectiveness of regorafenib for the treatment of metastatic colorectal cancer (CRC) in real-world clinical practice that was conducted in 13 different countries in Asia, Europe and Latin America. The primary endpoint of the study was incidence of all treatment-emergent AEs (TEAEs), and secondary endpoints included overall survival (OS), progression-free survival (PFS), and disease control rate (DCR).ResultsThe global study population (N = 1037) included 128 Taiwanese patients with a median age of 64 years, median weight of 62.02 kg and 66.41% were male. Reduced initiating doses of regorafenib and dose interruptions were common in Taiwanese patients (71.87% and 50.00%, respectively). The safety profile of regorafenib was consistent with that seen in Asian patients in the clinical development trials, including the CORRECT and CONCUR studies, with hand-foot-skin reactions (HFSR) of any grade occurring in 33.59% of patients. Median OS was 11.64 months in the Taiwanese patients (95% confidence interval [CI], 8.36-13.82) and median PFS was 2.17 months (95% CI, 1.97-2.89).ConclusionThe safety and effectiveness of regorafenib in this real-world study was generally consistent with the known efficacy and safety profile in Asian patients in clinical trials.Trial RegistrationNCT02042144.Copyright © 2020 Formosan Medical Association. Published by Elsevier B.V. All rights reserved.

13 keywords...

hide…