Contributors: [Chen LT ] National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan. Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan. [Macarulla T] Hospital Universitari Vall d’Hebron, Barcelona, Spain. Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. [Blanc JF] Groupe Hospitalier Haut-Lévêque, CHU Bordeaux, Pessac, France. [Mirakhur B] Ipsen Biopharmaceuticals, Inc., Basking Ridge, USA. [Jong FA] Global Medical Affiars, Servier, Zürich, Switzerland. [Belanger B] Ipsen Biopharmaceuticals, Inc., Cambridge, USA; Hospital Universitari Vall d'Hebron; Vall d'Hebron Barcelona Hospital Campus
نبذة مختصرة : NAPOLI-1; Liposomal irinotecan; Survival outcomes NAPOLI-1; Irinotecan liposòmic; Resultats de supervivència NAPOLI-1; Irinotecan liposomal; Resultados de supervivencia NAPOLI-1 (NCT01494506) was a phase III study of liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. This post hoc analysis of NAPOLI-1 aimed to develop a predictive nomogram for overall survival (OS) at 6 and 12 months. Analyses were derived from all patients in NAPOLI-1 randomized to receive nal-IRI+5-FU/LV, nal-IRI monotherapy, or 5-FU/LV combination therapy. OS was associated with baseline factors using univariate and multivariable Cox analyses. A predictive nomogram was derived and validated using a concordance index and calibration plots. The univariate analyses identified 21 independent factors that contributed to OS, with eight factors significantly associated with OS. The Karnofsky Performance Score contributed the largest number of points (100), followed by presence of liver metastasis (98) and randomization to nal-IRI+5-FU/LV (96). The other baseline factors showing effects were albumin (g/dL), neutrophil/lymphocyte ratio, carbohydrate antigen 19-9 (U/mL), disease stage at diagnosis, and body mass index (kg/m2). The nomogram was used to predict the 6- and 12-month survival probability. The mean absolute errors between the observed and predicted probabilities for OS at 3, 6, and 9 months were 0.07, 0.08, and 0.07, respectively. This nomogram, based on NAPOLI-1, provides additional insight to aid decision-making for patients with mPDAC after previous gemcitabine-based therapy. This study (NCT01494506) was supported by Merrimack Pharmaceuticals, Inc., Cambridge, MA, USA. Analysis sponsored by Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, USA.
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