Fruquintinib in metastatic colorectal cancer: "acceptable" safety profile
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Fruquintinib in metastatic colorectal cancer: "acceptable" safety profile The safety profile of fruquintinib, used in Chinese patients with previously treated metastatic colorectal cancer (mCRC) enrolled in the phase 3 FRESCO* trial, is "acceptable" and similar to that of other small-molecule VEGFR** inhibitors, say researchers from China. The researchers evaluated the safety profile of fruquintinib, in particular pre-defined adverse events of special interest (AESIs), in the FRESCO trial, a multicentre, randomised phase 3 trial that compared fruquintinib 5mg once daily for 3 weeks in a 28-day cycle versus placebo in Chinese patients with mCRC. The analysis of data from 415 patients showed that 274/278 patients (98.6%) in the fruquintinib group reported at least one treatment-emergent adverse event (TEAE), compared with 121/137 patients (88.3%) in the placebo group. The number of patients with treatment-related TEAEs was 266 (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group. The most common treatment-related AESIs of all grades in the fruquintinib group were hypertension (55.4%), hand-foot skin reaction (49.3%) and proteinuria (42.1%). These were also the most common treatmentrelated grade ≥ 3 AESIs (21.2%, 10.8% and 3.2%, respectively). The median time to onset of these events was 10, 21 and 20 days, respectively. Other treatment-related AESIs in the fruquintinib group included haemorrhage (35.3%), thyroid dysfunction (19.4%) and hepatotoxicities (3.2%). Subgroup analysis by age, gender and BMI revealed a safety profile similar to that of the entire population. * Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients. The trial was co-funded by Eli Lilly and Company, USA, and Hutchison MediPharma, China. ** vascular endothelial growth factor receptor Li J, et al. Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the 803502475 Phase 3 FRESCO Trial. Advances in Therapy : 8 Sep 2020. Available from: URL: https://doi.org/10.1007/s12325-020-01477-w
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Reactions 26 Sep 2020 No. 1823
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