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Open AccessArticle

Nomogram for Predicting Survival in Patients Treated with Liposomal Irinotecan Plus Fluorouracil and Leucovorin in Metastatic Pancreatic Cancer

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National Institute of Cancer Research, National Health Research Institutes, Tainan 704, Taiwan
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Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan 704, Taiwan
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Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, 08035 Barcelona, Spain
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Groupe Hospitalier Haut-Lévêque, CHU Bordeaux, 33600 Pessac, France
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Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ 07920, USA
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Global Medical Affiars, Servier, 8002 Zürich, Switzerland
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Ipsen Biopharmaceuticals, Inc., Cambridge, MA 02142, USA
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Mayo Clinic Cancer Center, Phoenix, AZ 85054, USA
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German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany
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West German Cancer Center, University Hospital Essen, 45147 Essen, Germany
*
Author to whom correspondence should be addressed.
Cancers 2019, 11(8), 1068; https://doi.org/10.3390/cancers11081068
Received: 20 June 2019 / Revised: 23 July 2019 / Accepted: 23 July 2019 / Published: 28 July 2019
(This article belongs to the Special Issue Advances in Pancreatic Cancer Research)
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. View Full-Text
Keywords: liposomal irinotecan; NAPOLI-1; nomogram; pancreatic cancer; survival outcomes liposomal irinotecan; NAPOLI-1; nomogram; pancreatic cancer; survival outcomes
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Chen, L.-T.; Macarulla, T.; Blanc, J.-F.; Mirakhur, B.; de Jong, F.A.; Belanger, B.; Bekaii-Saab, T.; Siveke, J.T. Nomogram for Predicting Survival in Patients Treated with Liposomal Irinotecan Plus Fluorouracil and Leucovorin in Metastatic Pancreatic Cancer. Cancers 2019, 11, 1068.

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