Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan.

Background/purpose: This analysis reports safety and effectiveness data from the Taiwanese cohort of the CORRELATE study.
Methods: CORRELATE 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).
Results: The 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).
Conclusion: The 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 Registration: NCT02042144.
Competing Interests: Declaration of competing interest K-HY has received honoraria from Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, and Takeda. C-WD and Y-SL are full-time employees of Bayer. SF-B is a full-time employee of Bayer and owns stock in Bayer; MD has received grants/research support from Merck Serono and Roche; has participated on advisory boards for Amgen, Bayer, Celgene, Ipsen, Merck Serono, Roche and Servier; has received honoraria from Amgen, Bayer, Ipsen, Lilly, Merck Serono, Novartis, Roche and Servier; and has received travel/accommodations/expenses from Amgen, Ipsen, Lilly, Merck Serono, Merck Sharp & Dohme, and Roche. T-SY, T-CH, WT-LC, H-HC, H-WT, B-WL, F-CK, F-FC and J-YW have no conflicts of interest to report.
(Copyright © 2020 Formosan Medical Association. Published by Elsevier B.V. All rights reserved.)