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

Yeh, Kun‐Huei; Yang, Tsung‐Ming; Hsu, Tzu‐Chi; Chen, William Tzu-Liang; Chen, Hong Hwa; Teng, Hao Wei; Lin, Bo; Kuan, Feng Che; Chiang, Feng Fan; Duann, Chi Wei; Li, Ying Shiuan; Lin, Meng-Ting; Fiala-Buskies, Sabine; Ducreux, Michel; Wang, Jaw‐Yuan

doi:10.1016/j.jfma.2020.12.015

Cited by 8 publications

(6 citation statements)

References 16 publications

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“…The proportion of liver metastasis in this study was 45.45%. The mPFS of patients with liver metastasis was 12.85 months, and the mOS had not yet been reached; these figures were higher than those reported in a previous study ( 19 ). In addition, 48.05% of the patients in this study had lung metastasis, and these patients had an overall mPFS of 8.48 months and an mOS of 16.85 months; these figures are lower than those previously reported in studies examining treatment regimens of regorafenib with triprizumab ( 20 ).…”

Section: Resultscontrasting

confidence: 74%

Efficacy and safety of regorafenib in the treatment of metastatic colorectal cancer: a retrospective cohort study

Yan,

Liu,

Zhang

et al. 2024

J Gastrointest Oncol

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Background The majority of studies of regorafenib now were small-sample and single-arm, which potentially limits the strength of evidence. We conduct the study to identify the efficacy and safety of regorafenib for patients with metastatic colorectal cancer (mCRC) in real-world applications. Methods mCRC patients who underwent regorafenib second line or post-second line treatment with at least one assessable lesion were analyzed. Patients received different doses of regorafenib and different combination regimens. The patients were followed up with laboratory tests and imaging examinations every 3 months to evaluate the efficacy and adverse events (AEs). The primary endpoint of this study was median overall survival (mOS), and the secondary endpoints were median progression-free survival (mPFS), the objective response rate (ORR), the disease control rate (DCR), and AEs. Results A total of 77 patients (45 males and 32 females, aged 58.80±11.65 years) were enrolled in the study. Most primary tumors were located in the rectum (59.74%), and the vast majority of tumors (89.62%) had an adenocarcinoma histological type. The 77 patients had an mOS of 17.8 months, a progression-free survival (PFS) of 4.63 months, an ORR of 6.76%, and a DCR of 55.41%. Patients underwent regorafenib third-line therapy had significantly higher overall survival (OS) than those underwent regorafenib post- third-line treatment (P=0.03). The neutrophil to lymphocyte ratio (NLR) was an independent factor affecting the OS of the mCRC patients [hazard ratio (HR) =1.12, P=0.03]. In both univariate and multivariate analyses, discontinued use of regorafenib after progression reduced patients’ PFS (HR =3.07, P<0.001; HR =2.78, P=0.007). In terms of the tolerated dose, patients receiving 120 mg regorafenib had the longest OS numbers, but there was no statistical difference. We analyzed the effect of the baseline NLR on the OS of patients receiving regorafenib combined with immunotherapy, and found that the NLR ratio cut-off value was 4.4, and patients with a NLR ratio ≤4.4 benefited significantly in terms of OS (P=0.03). The AEs included 21 (27.27%) cases of hand and foot skin reaction, 15 (19.48%) cases of fatigue, 9 (11.69%) cases of pain, 9 (11.69%) cases of nausea, 9 (11.69%) cases of fever, 9 (11.69%) cases of cough, and so on. Conclusions Regorafenib is relatively effective and safe as a third-line and posterior treatment of mCRC. Patients underwent regorafenib third-line therapy had longer OS than those underwent regorafenib post- third-line treatment. Moreover, PFS benefits can still be obtained by continuing regorafenib treatment after progression. Grade 1–2 AEs were common, but these were usually tolerated by most patients.

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Section: Resultscontrasting

confidence: 74%

Efficacy and safety of regorafenib in the treatment of metastatic colorectal cancer: a retrospective cohort study

Yan,

Liu,

Zhang

et al. 2024

J Gastrointest Oncol

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“…4 , 24 In a prospective observational study, most patients from Taiwan (71.8%) started regorafenib with a dose lower than 160 mg/d, and 80% of patients received a reduced dose as their final dose. 25 According to the subgroup analysis of the CORRECT study, the frequencies of adverse events were significantly different in the Japanese and non-Japanese subgroups, which may partially explain the lower tolerance observed in patients in our study relative to those in most western studies. [26][27][28] Additionally, a dose-escalation strategy based on the ReDos study is the most commonly used in clinical practice, in which patients start with a dose of 80 mg/day and receive weekly dose escalation if no significant drug-related toxicities are observed, up to 160 mg/d.…”

Section: Discussionmentioning

confidence: 51%

Efficacy and Safety Comparison of Regorafenib and Fruquintinib in Metastatic Colorectal Cancer-An Observational Cohort Study in the Real World

Zhang

Chen

Wang

et al. 2022

Clinical Colorectal Cancer

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“…The incidence of AEs was relatively low compared with other studies, which the authors attributed to the fact that almost half of the patients received less than the recommended daily dose (160 mg/day) of regorafenib (45). The real-world analysis of the CORRELATE trial in the Taiwanese cohort depicted a consistent safety report, as observed among Asian patients in trials such as the CORRECT and the CONCUR studies, suggesting HFSR occurring in 33.59% of patients (51). The common AEs observed with regorafenib use were consistent with other studies (Table 2).…”

Section: Regorafenib: Safety From Studies With a Majority Of Caucasian Patientsmentioning

confidence: 58%

Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review

Xu¹,

Yu²,

Liu³

et al. 2022

Transl Cancer Res TCR

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Objective: The efficacy and safety of regorafenib and fruquintinib are studied extensively in different populations and trials across the world to determine their potential benefits. Here we review the efficacy and safety of regorafenib and fruquintinib as third-line treatment option for colorectal cancer (CRC).Background: CRC is the third most prevalent cancer worldwide, but the optimal third-line treatment option is still debatable. Regorafenib is a multikinase inhibitor that inhibits several cell signaling receptors, including vascular endothelial growth factor receptors (-1, -2, and -3) (VEGFRs), platelet-derived growth factor (PDGF), fibroblast growth factor, epidermal growth factor (EGF), angiotensin II, and Rapidly Accelerated Fibrosarcoma kinase pathway. On the other hand, fruquintinib inhibits signaling through the VEGFRs family. Regorafenib and fruquintinib have both received United States Food and Drug Administration (USFDA) approval for treating metastatic CRC (mCRC) in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor therapy, and Rat sarcoma wild type, an anti-EGF receptor therapy.Methods: A review of literature was conducted in PubMed and Embase with the keywords "regorafenib" OR "fruquintinib" AND "colorectal cancer" for clinical studies performed in randomized controlled settings and real-world settings.Conclusions: Regorafenib and fruquintinib are effective and well tolerated options for the third-line treatment of patients with CRC. Both have a similar survival outcome with Regorafenib showing a slightly better toxicity profile.

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

Cited by 8 publications

References 16 publications

Efficacy and safety of regorafenib in the treatment of metastatic colorectal cancer: a retrospective cohort study

Efficacy and safety of regorafenib in the treatment of metastatic colorectal cancer: a retrospective cohort study

Efficacy and Safety Comparison of Regorafenib and Fruquintinib in Metastatic Colorectal Cancer-An Observational Cohort Study in the Real World

Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review

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