The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.
Fruquintinib (a novel, highly selective oral tyrosine kinase inhibitor targeting VEGFR-1, -2, and -3) has demonstrated efficacy in chemotherapy-resistant metastatic colorectal cancer (mCRC) in two phase III trials, FRESCO and FRESCO-2. In France, fruquintinib has been available through compassionate use since January 16, 2024, for all patients with chemotherapy-refractory mCRC, and its reimbursement is expected in the coming months. However, limited real-world data are currently available regarding the use of this new treatment and the identification of predictive factors of its efficacy, both clinically and biologically. Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters. The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib. As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
300
Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.
overall survival
OS is defined as the time interval (months) between the date of initiation of treatment with fruquintinib and the date of death (from any cause).
Time frame: up to 1 year after treatment start
progression free survival
Time (months) from initiation of treatment with fruquintinib to radiological and/or clinical tumour progression or death from any cause.
Time frame: up to 1 year after treatment start
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