{
  "abstract": "Objective To compare the real-world effectiveness and recorded safety of first-line liposomal irinotecan+oxaliplatin+fluorouracil+leucovorin (NALIRIFOX), modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (Gem/NabP) in treatment-naïve patients with advanced pancreatic ductal adenocarcinoma (PDAC) in Thailand.Methods and analysis This retrospective, multicentre cohort study included adult patients with unresectable locally advanced or metastatic PDAC who initiated first-line NALIRIFOX, mFOLFIRINOX or Gem/NabP across 10 major Thai cancer centres between January 2021 and July 2024. Propensity score matching was performed to reduce treatment selection bias using age, sex, Eastern Cooperative Oncology Group performance status, metastatic burden, primary tumour location and baseline albumin. Overall survival (OS) and progression-free survival (PFS) were the primary outcomes. Secondary outcomes were objective response rate (ORR) and grade ≥3 treatment-related adverse events. Safety analyses were limited to matched patients with sufficient follow-up documentation to assess toxicity retrospectively.Results Of 513 eligible patients, 199 were included in the matched cohort: 52 received NALIRIFOX, 105 mFOLFIRINOX and 42 Gem/NabP. Median OS was 10.4 months for NALIRIFOX, 9.6 months for mFOLFIRINOX and 6.0 months for Gem/NabP. NALIRIFOX was associated with similar OS to mFOLFIRINOX (HR 1.09, 95% CI 0.72 to 1.67; p=0.68) and longer OS than Gem/NabP (HR 1.68, 95% CI 1.03 to 2.75; p=0.04). Median PFS was 5.0 months for both NALIRIFOX and mFOLFIRINOX and 4.3 months for Gem/NabP; NALIRIFOX showed longer PFS than Gem/NabP (HR 1.63, 95% CI 1.05 to 2.50; p=0.03), while PFS was similar between NALIRIFOX and mFOLFIRINOX. ORR was 37.5% for NALIRIFOX, 23.8% for mFOLFIRINOX and 40.5% for Gem/NabP. Recorded grade ≥3 toxicities appeared lower with NALIRIFOX, although cross-regimen safety comparisons were limited by retrospective toxicity ascertainment and likely differential reporting. Baseline carbohydrate antigen 19-9 remained imbalanced after matching because it was not included in the propensity model.Conclusion In this multicentre real-world matched cohort of advanced PDAC, NALIRIFOX and mFOLFIRINOX were associated with comparable survival outcomes, and both were associated with more favourable survival than Gem/NabP. Recorded grade ≥3 toxicities appeared lower with NALIRIFOX, but safety findings should be interpreted cautiously because of retrospective toxicity capture and residual confounding. Prospective studies are needed to validate these findings.",
  "authors": [
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand",
        "Division of Medical Oncology, Department of Medicine, Phramongkutklao College of Medicine, Bangkok, Thailand"
      ],
      "name": "Tawasapon Thambamroong"
    },
    {
      "affiliations": [
        "Department of Medicine, Chaophya Abhaibhubejhr Hospital, Mueang Prachin Buri District, Thailand"
      ],
      "name": "Ratchadakorn Meesart"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand",
        "Division of Medical Oncology, Department of Medicine, Phramongkutklao College of Medicine, Bangkok, Thailand"
      ],
      "name": "Naiyarat Prasongsook"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand"
      ],
      "name": "Nuttapong Ngamphaiboon"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand"
      ],
      "name": "Charuwan Akewanlop"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand"
      ],
      "name": "Suebpong Tanasanvimon"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand",
        "Division of Medical Oncology, Department of Medicine, Phramongkutklao College of Medicine, Bangkok, Thailand"
      ],
      "name": "Jarearnjit Phavirunsiri"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand"
      ],
      "name": "Nussara Pakvisal"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand"
      ],
      "name": "Krittiya Korphaisarn"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Prince of Songkla University Faculty of Medicine, Hat Yai, Thailand"
      ],
      "name": "Chirawadee Sathitruangsak"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand"
      ],
      "name": "Teerada Siripoon"
    },
    {
      "affiliations": [
        "Department of Medicine, Sakon Nakhon Hospital, That Choeng Chum, Thailand"
      ],
      "name": "Pronwasun Simseekeaw"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Srinakharinwirot University Faculty of Medicine, Bangkok, Thailand"
      ],
      "name": "Chanchai Charonpongsuntorn"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Khon Kaen University Faculty of Medicine, Khon Kaen, Thailand"
      ],
      "name": "Kosin Wirasorn"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand"
      ],
      "name": "Gorawich Kerkarchachai"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Thammasat University Faculty of Medicine, Khlong Nueng, Thailand"
      ],
      "name": "Panuch Eiamprapaporn"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Chiang Mai University Faculty of Medicine, Chiang Mai, Thailand"
      ],
      "name": "Thatthan Suksombooncharoen"
    },
    {
      "affiliations": [
        "Oncology Unit, Department of Medicine, Rajavithi Hospital, Rangsit University College of Medicine, Mueang Pathum Thani District, Thailand"
      ],
      "name": "Sunatee Sa-nguansai"
    },
    {
      "affiliations": [
        "Department of Medicine, Phrapokklao Hospital, Chanthaburi, Thailand"
      ],
      "name": "Alan Patiluntakankul"
    },
    {
      "affiliations": [
        "Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand"
      ],
      "name": "Ekaphop Sirachainan"
    }
  ],
  "title": "Real-world effectiveness of NALIRIFOX versus modified FOLFIRINOX or gemcitabine and nab-paclitaxel in first-line advanced pancreatic adenocarcinoma: a multicentre propensity-matched study",
  "uid": "6b674196-134c-5285-b783-bed970088db4"
}