{
  "abstract": "Background and Importance Metastatic pancreatic cancer (mPC) has a very poor prognosis and limited treatment options. The regimen of liposomal irinotecan in combination with fluorouracil and folinic acid (NALIRI) has proven effective. However, data from real-world clinical practice remain scarce.Aim and Objectives To evaluate the effectiveness and safety profile of NALIRI in patients with mPC under normal clinical practice conditions.Material and Methods Observational, retrospective, single-centre study. All patients treated with NALIRI between December 2016 and April 2025 were included. Demographic data, location of metastases, previous treatments, functional status (ECOG) at the start of NALIRI, duration of treatment, follow-up time and tolerance were collected. Effectiveness was assessed using RECIST criteria, progression-free survival (PFS) and overall survival (OS), using Kaplan–Meier curves. Toxicities were classified according to CTCAE v5.0. Data were obtained from electronic medical records and analysed using R software (v4.2.2).Results Forty-six patients with a median age of 65.5 years (range:45–80) were included; 52% were women. Twenty-two percent had undergone surgery. The most common metastases were hepatic (44%), peritoneal (30%), pulmonary (26%), adrenal (11%) and lymph node (9%). In metastatic disease, 40 patients received gemcitabine-nabpaclitaxel as first-line treatment. Seventy-two percent of patients received NALIRI as second-line treatment. The ECOG at the start of treatment with NALIRI was 0 (13%), 1 (65%) and 2 (20%).The median follow-up was 5 months (range: 1-19) and the median duration of treatment was 2.5 months (range: 0.5-17). At the end of the study, 35 patients had died. The PFS and OS data were 3.5 months (95% CI:2-5) and 6 months (95% CI:4.4-8), respectively.Ninety-four percent of patients experienced some adverse reaction. The most common toxicities were gastrointestinal (67%; five grade 3 cases), haematological (59%; one grade 4 and three grade 3) and asthenia (63%; one grade 4 and five grade 3). Other toxicities included abdominal discomfort (11%), neurotoxicity (15%), stomatitis (17%; two grade 3) and hand-foot syndrome (9%). Dose reductions were performed in 17 patients, treatment delays in 19 and suspensions due to toxicity in 12 cases.Conclusion and Relevance The effectiveness of NALIRI was comparable to that of the NAPOLI-1 trial. NALIRI showed a high incidence of adverse effects, which in many cases required dose adjustments or treatment discontinuation.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "C Rodriguez-Tenreiro Rodriguez"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "M Muñoz Villasur"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "A Caso González"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "C Díaz Romero"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "C Fadón Herrera"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "AM Gómez Mato"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "M Latasa Berasategui"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "C Espárrago Fernández"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "M Varela Ferreiro"
    },
    {
      "affiliations": [
        "Central University Hospital of Asturias, Hospital Pharmacy, Oviedo, Spain"
      ],
      "name": "A Lozano Blázquez"
    }
  ],
  "title": "4CPS-013 Effectiveness and safety of liposomal irinotecan in the treatment of metastatic pancreatic cancer in routine clinical practice",
  "uid": "952f8c8c-8143-5ce8-802b-d743d94647f8"
}