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Pancreas. 2020 Jan;49(1):62-75. doi: 10.1097/MPA.0000000000001455.

Liposomal Irinotecan + 5-FU/LV in Metastatic Pancreatic Cancer: Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial.

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From the Vall d'Hebron University Hospital (HUVH) and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
National Institute of Cancer Research, National Health Research Institutes.
Department of Internal Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan.
Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital.
National Yang-Ming University School of Medicine, Taipei, Taiwan.
Division of Solid Tumor Translational Oncology, West German Cancer Center, University Hospital Essen.
German Cancer Consortium (DKTK, partner site Essen) and German Cancer Research Center, DKFZ, Heidelberg, Germany.
The Royal Marsden NHS Foundation Trust, London and Surrey, United Kingdom.
Department of Oncology, Szent László Hospital, Budapest, Hungary.
Pôle ADEN, Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France.
Department of Internal Medicine and Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
St. John of God Hospital, Subiaco, Western Australia, Australia.
Ipsen Bioscience, Inc, Cambridge, MA.
Washington University in St. Louis, St. Louis, MO.



The NAnoliPOsomaL Irinotecan (NAPOLI-1) study (NCT01494506) was the largest global phase 3 study in a post-gemcitabine metastatic pancreatic adenocarcinoma (mPAC) population (N = 417). The subanalyses reported here investigated the prognostic effect of tumor characteristics and disease stage, prior treatment characteristics, baseline patient characteristics on survival outcomes in NAPOLI-1, and whether liposomal irinotecan (nal-IRI) + 5-fluorouracil/leucovorin (5-FU/LV) benefited patients with mPAC across subgroups.


Post hoc analyses were performed in the NAPOLI-1 population (4 across tumor characteristics and disease stage, 6 across prior treatment characteristics, and 4 across patient baseline characteristics). Survival outcomes were estimated by Kaplan-Meier analysis and patient safety data were evaluated.


Mortality and morbidity risk was lower on nal-IRI+5-FU/LV treatment across subgroups. Exceptions were patients who had received prior nonliposomal irinotecan and those who had undergone prior Whipple procedure (overall survival hazard ratio = 1.25 and 1.23, respectively). Decreased appetite, liver metastases, and number of measurable metastatic lesions seemed to be prognostic of survival in this population. Subgroup safety data were generally comparable with those in the overall NAPOLI-1 safety population.


A diverse population of patients with mPAC that progressed on gemcitabine-based therapy benefited from nal-IRI+5-FU/LV versus 5-FU/LV, potentially helping guide treatment decisions for challenging cases.

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