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-wo...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-11-01
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| Series: | Journal of the Formosan Medical Association |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S092966462030615X |
| _version_ | 1818729027524886528 |
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| author | Kun-Huei Yeh Tsai-Sheng Yang Tzu-Chi Hsu William Tzu-Liang Chen 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 Jaw-Yuan Wang |
| author_facet | Kun-Huei Yeh Tsai-Sheng Yang Tzu-Chi Hsu William Tzu-Liang Chen 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 Jaw-Yuan Wang |
| author_sort | Kun-Huei Yeh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T22:39:22Z |
| format | Article |
| id | doaj.art-1e54318f1fea4699b5f14328c5bd9068 |
| institution | Directory Open Access Journal |
| issn | 0929-6646 |
| language | English |
| last_indexed | 2024-12-17T22:39:22Z |
| publishDate | 2021-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of the Formosan Medical Association |
| spelling | doaj.art-1e54318f1fea4699b5f14328c5bd90682022-12-21T21:30:00ZengElsevierJournal of the Formosan Medical Association0929-66462021-11-011201120232031Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE TaiwanKun-Huei Yeh0Tsai-Sheng Yang1Tzu-Chi Hsu2William Tzu-Liang Chen3Hong-Hwa Chen4Hao-Wei Teng5Bo-Wen Lin6Feng-Che Kuan7Feng-Fan Chiang8Chi-Wei Duann9Ying-Shiuan Li10Meng-Ting Lin11Sabine Fiala-Buskies12Michel Ducreux13Jaw-Yuan Wang14Department of Medical Oncology, National Taiwan University Cancer Center, and Department of Oncology, National Taiwan University Hospital, Taipei, TaiwanDivision of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkuo, Taipei, TaiwanDepartment of Colon and Rectal Surgery, Mackay Memorial Hospital, Taipei, TaiwanDepartment of Surgery, China Medical University Hospital, Taichung, TaiwanDepartment of Colorectal Surgery, Chang Gung Memorial Hospital, Kaohsiung, TaiwanDivision of Medical Oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan and School of Medicine, National Yang-Ming University, Taipei, TaiwanDivision of Colon & Rectal Surgery, National Cheng Kung University Hospital, Tainan, TaiwanDepartment of Hematology and Oncology, Chang Gung Memorial Hospital, Chia-Yi Branch, TaiwanDivision of Colon & Rectal Surgery, Taichung Veterans General Hospital, Taichung, TaiwanMedical Department, Bayer Taiwan, Taipei, TaiwanMedical Department, Bayer Taiwan, Taipei, TaiwanMedical Department, Bayer Taiwan, Taipei, TaiwanSBU Oncology, Pharmaceuticals, Clinical Statistics EU, Bayer AG, Wuppertal, GermanyGastrointestinal Oncology Unit, Gustave Roussy Cancer Campus Grand Paris, Villejuif, FranceDivision of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Corresponding author. Kaohsiung Medical University Hospital, No. 100 Tzyou 1st Road, Kaohsiung, 807, 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.http://www.sciencedirect.com/science/article/pii/S092966462030615XColorectal cancerRegorafenibTaiwan |
| spellingShingle | Kun-Huei Yeh Tsai-Sheng Yang Tzu-Chi Hsu William Tzu-Liang Chen 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 Jaw-Yuan Wang Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan Journal of the Formosan Medical Association Colorectal cancer Regorafenib Taiwan |
| title | Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan |
| title_full | Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan |
| title_fullStr | Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan |
| title_full_unstemmed | Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan |
| title_short | Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan |
| title_sort | real world evidence of the safety and effectiveness of regorafenib in taiwanese patients with metastatic colorectal cancer correlate taiwan |
| topic | Colorectal cancer Regorafenib Taiwan |
| url | http://www.sciencedirect.com/science/article/pii/S092966462030615X |
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