{
  "abstract": "Background and Importance Fruquintinib is a selective inhibitor of VEGFR-1, 2, and 3 tyrosine kinase. It is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF and/or anti-EGFR therapies, and have progressed or are intolerant to trifluridine-tipiracil (TAS-102) or regorafenib.Aim and Objectives To evaluate the effectiveness and safety of fruquintinib in adult patients with mCRC treated at three tertiary hospitals.Material and Methods Observational, retrospective, multicentre study was conducted in adult patients with mCRC treated with fruquintinib between December 2024 and September 2025. The primary endpoints for effectiveness were median progression-free survival (PFS) and median overall survival (OS). Additional data collected included demographics (gender, age), KRAS mutation status, prior treatments, treatment initiation date, duration of treatment, dose reductions, and adverse events (AEs).Results Thirty-one patients (58% male) with a mean age of 66.9 years (range 52–77) were included. KRAS mutations (KRASm) were present in 58% of cases. The median number of prior treatment lines was four. Prior to fruquintinib, 22 patients had received TAS-102 plus bevacizumab, eight received TAS-102 monotherapy, and eight received regorafenib. Patients received a median of three treatment cycles (range: 1–7). At the data cut-off, disease progression was observed in nine patients (67% KRASm), with the median PFS not yet reached. Six-month PFS was 74.2%. Five patients (all KRASm) had died, with a 6 month OS rate of 83.8%.Adverse events were reported in 87.1% of patients. The most common AEs were asthenia (58%), hypertension (45%), hand-foot syndrome (16%), and diarrhoea (13%). Dose reductions were required in 48% of patients–most commonly due to asthenia (n=6), hypertension (n=5), gastrointestinal symptoms (n=3), and hyperbilirubinemia (n=1). Three patients discontinued treatment due to AEs (two due to hypertension and one due to elevated transaminases).Conclusion and Relevance Fruquintinib demonstrated limited effectiveness in a heavily pre-treated real-world mCRC population, with poorer outcomes observed in patients with KRAS mutations. Its safety profile was consistent with known toxicities and required frequent dose modifications. Larger studies with extended follow-up are warranted to validate these findings.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "San Cecilio University Hospital, Hospital Pharmacy, Granada, Spain"
      ],
      "name": "MR Robles-Muñoz"
    },
    {
      "affiliations": [
        "Virgen De Las Nieves University Hospital, Hospital Pharmacy, Granada, Spain"
      ],
      "name": "Á García López"
    },
    {
      "affiliations": [
        "San Cecilio University Hospital, Hospital Pharmacy, Granada, Spain"
      ],
      "name": "S Cano Domínguez"
    },
    {
      "affiliations": [
        "San Cecilio University Hospital, Hospital Pharmacy, Granada, Spain"
      ],
      "name": "J Cabeza Barrera"
    }
  ],
  "title": "4CPS-308 Analysis of the effectiveness and safety of fruquintinib in metastatic colorectal cancer in real-world clinical practice",
  "uid": "eadb7aed-c451-5f53-bb90-6c73c66c694e"
}