Abstract 1520P
Background
The NAPOLI 3 trial reported a survival benefit with the combination therapy nanoliposomal Irinotecan, 5-Fluorouracil, Leucovorin and Oxaliplatin (NALIRIFOX) versus nabPaclitaxel and Gemcitabine in first line therapy for metastatic pancreatic ductal Adenocarcinoma (mPDAC). In this study we aim to analyze the efficacy and feasibility of this promising new first line regime in an early real-world setting.
Methods
The analyzed population included patients with unresectable or metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX at 3 Austrian cancer centers. The primary endpoint of the study was overall survival (OS), while secondary endpoints included progression free survival (PFS), overall response rate (ORR), and safety. All patient data including molecular profiles were obtained by individual chart review.
Results
From February 2023 to April 2024, 40 patients were enrolled. After a median follow up of 7.9 months (95% CI 6.44-10.36), median PFS was 5.3 months (95% CI 3.45-6.71), and median OS was 12.7 months (95% CI 8.94-NR). The investigator assessed confirmed ORR was 63% and the disease control rate was 78%. Any grade adverse events (AEs) occurred in 40 patients (100%). Grade 3-4 AEs occurred in 17 patients (42.50%). The most common side effects were hypokalemia (53.13%) and diarrhea (52.5%). Among hypokalemia cases, 82% experienced severe (G3/G4) adverse events, while for diarrhea, the percentage of severe AEs was 19%. In 9 patients (22.50%) treatment-emergent adverse events leading to discontinuation. No treatment-related treatment-emergent adverse events leading to death were detected. KRAS was present in 87.5%.
Conclusions
To the best of our knowledge this is the first real-world analysis of NALIRIFOX in pancreatic cancer. Efficacy results confirm the phase NAPOLI 3 trial while holding promising safety.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
A. Reichinger.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1525P - Nab-paclitaxel/gemcitabine with or without epigenetic targeting followed by consolidating immune targeting with durvalumab and lenalidomide in patients with advanced pancreatic ductal adenocarcinoma: Results from the SEPION/AIO-PAK-0118 phase I/II study
Presenter: Jens Siveke
Session: Poster session 18
1527P - GnP vs mFOLFIRINOX or S-IROX in metastatic pancreatic cancer: 1-year follow-up updated data from the GENERATE (JCOG1611)
Presenter: Satoshi Kobayashi
Session: Poster session 18
1528P - TCOG T5221 trial: A phase II randomized study of gemcitabine and nab-paclitaxel in combination with S- 1/LV (GASL) or oxaliplatin (GAP) as first-line treatment for metastatic pancreatic cancer
Presenter: Yung-yeh Su
Session: Poster session 18
1531TiP - TWINPEAK phase I/II study, PT886 a bispecific antibody targeting claudin 18.2 and CD47 in combination with chemotherapy and/or pembrolizumab in gastric/GEJ-carcinomas or PDAC
Presenter: Michael Overman
Session: Poster session 18
1532TiP - Zolbetuximab with gemcitabine + nab-paclitaxel (GN) in first-line treatment of Claudin 18.2–positive metastatic pancreatic cancer (mPC): Phase II, open-label, randomized study
Presenter: Wungki Park
Session: Poster session 18
1533TiP - A multicenter, open-label phase II study to evaluate the efficacy and safety of pimicotinib (CSF-1R inhibitor) in combination with chemotherapy with or without toripalimab in patients (pts) with advanced pancreatic ductal adenocarcinoma (aPDAC)
Presenter: Xiaofei Zhang
Session: Poster session 18
1534TiP - Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients-VESPA trial
Presenter: Alfredo Budillon
Session: Poster session 18