TY - JOUR
T1 - Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer
T2 - CORRELATE Taiwan
AU - Yeh, Kun Huei
AU - Yang, Tsai Sheng
AU - Hsu, Tzu Chi
AU - Tzu-Liang Chen, William
AU - Chen, Hong Hwa
AU - Teng, Hao Wei
AU - Lin, Bo Wen
AU - Kuan, Feng Che
AU - Chiang, Feng Fan
AU - Duann, Chi Wei
AU - Li, Ying Shiuan
AU - Lin, Meng Ting
AU - Fiala-Buskies, Sabine
AU - Ducreux, Michel
AU - Wang, Jaw Yuan
N1 - Funding Information:
The authors would like to thank the patients, their families and all of the investigators who participated in the study. This study was funded by Bayer AG, Leverkusen, Germany. Bayer collaborated with the investigators on protocol design, data collection, and interpretation. Editorial assistance in the preparation of this manuscript was provided by Dr Alister Smith of MIMS (Hong Kong) Limited, with financial support from Bayer Taiwan. The authors retained editorial control over the manuscript and the decision to publish.
Publisher Copyright:
© 2020 Formosan Medical Association
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85099159823&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85099159823&partnerID=8YFLogxK
U2 - 10.1016/j.jfma.2020.12.015
DO - 10.1016/j.jfma.2020.12.015
M3 - Article
C2 - 33422398
AN - SCOPUS:85099159823
SN - 0929-6646
VL - 120
SP - 2023
EP - 2031
JO - Journal of the Formosan Medical Association
JF - Journal of the Formosan Medical Association
IS - 11
ER -