Real-world experience of safety and effectiveness of regorafenib for treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumors, and hepatocellular carcinoma: a post-marketing surveillance study in Koreaopen access
- Authors
- Beom, S.-H.; Bae, K.B.; Zang, D.Y.; Bae, J.; Hwang, I.G.; Kang, H.J.; Woo, I.S.; Shim, B.Y.; Bae, B.-N.; Cheon, J.; Oh, S.-B.; Ahn, J.-B.
- Issue Date
- 2022
- Publisher
- Ivyspring International Publisher
- Keywords
- Colorectal cancer; Gastrointestinal stromal tumors; Hepatocellular carcinoma; Post-marketing surveillance; Real-world data; Regorafenib
- Citation
- Journal of Cancer, v.13, no.13, pp 3396 - 3403
- Pages
- 8
- Journal Title
- Journal of Cancer
- Volume
- 13
- Number
- 13
- Start Page
- 3396
- End Page
- 3403
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/71317
- DOI
- 10.7150/jca.74107
- ISSN
- 1837-9664
- Abstract
- Purpose: This regulatory post-marketing surveillance (PMS) study was performed to evaluate the safety and effectiveness of regorafenib on Korean patients with colorectal cancer (CRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC) in a real-world clinical setting. Methods: This PMS was conducted as a multi-center, prospective, observational study at 34 centers in Korea from August 2013 to August 2019. The primary objective was to evaluate the safety of regorafenib in real-world practice, with the secondary objective to investigate its effectiveness, including its overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: In total, 301 patients were included in the analysis (254 patients with CRC, 14 patients with GIST, and 33 patients with HCC). The incidence rates of adverse events (AEs) were 85.0%, 78.6%, and 81.8% in patients with CRC, GIST, and HCC, respectively. The most frequent AE related to regorafenib in the three cancer types was palmar-plantar erythrodysesthesia syndrome (PPES). The ORRs of patients with CRC, GIST, and HCC were 4.7%, 0%, and 41.4%, respectively. The median PFS and OS were 2.1 and 6.1 months for CRC, respectively; 9.2 and 16.4 months for GIST, respectively; and 5.5 months and not estimated (NE) for HCC, respectively. Patients who experienced a dose modification or discontinuation of regorafenib showed significantly shorter median PFS and OS (2.2 vs. 2.6 months, respectively, P = 0.0335 for PFS; 5.3 vs. 8.5 months, respectively, P = 0.0010 for OS). Conclusion: This PMS study, which is the largest surveillance study of CRC in Korea, found no newly identified safety concerns for patients who received regorafenib in the real-world setting. Additionally, the results of this study were consisted with those previously reported in phase III trials. © The author(s)
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