Fruit

Fruit is an observational, multicenter, retrospective and prospective Real-World Study on the use of Fruquintinib for patients with metastatic Colorectal Cancer who progressed after standard therapy.
Expanded-access programs are crucial to allow patients timely and early access to innovative drugs prior to their marketing authorisation. Their role is especially important for patients who cannot adequately be treated via current standard of care and who cannot enter a clinical trial.
Real-world data (RWD) generated from this setting may provide clinicians and researchers useful additional insights on efficacy and safety outcomes of novel treatments in a broader, unselected population, closer to the clinical practice.
Additionally, these data might also inform regulatory authorities and play a crucial role for the novel agents’ reimbursement process.

Patients 18 years of age or older with a diagnosis of mCRC, who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents if clinically appropriate, and who have progressed on or are intolerant to treatment with either FTD/TPI or regorafenib.

Eligibility criteria:

• Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines.
• ≥18 years of age.
• Histologically and/or cytologically documented metastatic colorectal adenocarcinoma.
• All the inclusion and exclusion criteria specified in the Italian Expanded Access Program protocol and based on EMA approval.

Fruquintinib is indicated for mCRC patients who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan- based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.

Primary objective of this study is to describe the efficacy outcomes of fruquintinib in terms of OS and PFS in a real-world population.

Secondary Objectives

• Describe the efficacy of fruquintinib in terms of Time to treatment failure (TTF).
• Describe the anti-tumor activity of fruquintinib in terms of disease control rate (DCR).
• Illustrate the characteristics (including, but not limited to, median age, performance status, number and sites of metastases, molecular profile of disease, prior regimens of treatment) of patients being offered access to fruquintinib.
• Report main treatment-related adverse events (TRAEs) concerning overall toxicity and G≥3 toxicity rates (including serious adverse events) in a real-life, unselected population.
• Characterize the frequency of patients experiencing dose modifications (including dose reductions, dose delays) and/or dose discontinuation of fruquintinib (and reason for discontinuation).