Nomogram for predicting survival in patients treated with liposomal irinotecan plus fluorouracil and leucovorin in metastatic pancreatic cancer

Li Tzong Chen, Teresa Macarulla, Jean Frédéric Blanc, Beloo Mirakhur, Floris A. de Jong, Bruce Belanger, Tanios Bekaii-Saab, Jens T. Siveke

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number1068
JournalCancers
Volume11
Issue number8
DOIs
StatePublished - Aug 1 2019

Fingerprint

irinotecan
Nomograms
Leucovorin
Pancreatic Neoplasms
Fluorouracil
gemcitabine
Survival
Adenocarcinoma
Random Allocation
Calibration
Albumins
Decision Making
Body Mass Index
Neutrophils
Therapeutics
Carbohydrates

Keywords

  • Liposomal irinotecan
  • NAPOLI-1
  • Nomogram
  • Pancreatic cancer
  • Survival outcomes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Chen, L. T., Macarulla, T., Blanc, J. F., Mirakhur, B., de Jong, F. A., Belanger, B., ... Siveke, J. T. (2019). Nomogram for predicting survival in patients treated with liposomal irinotecan plus fluorouracil and leucovorin in metastatic pancreatic cancer. Cancers, 11(8), [1068]. https://doi.org/10.3390/cancers11081068

Nomogram for predicting survival in patients treated with liposomal irinotecan plus fluorouracil and leucovorin in metastatic pancreatic cancer. / Chen, Li Tzong; Macarulla, Teresa; Blanc, Jean Frédéric; Mirakhur, Beloo; de Jong, Floris A.; Belanger, Bruce; Bekaii-Saab, Tanios; Siveke, Jens T.

In: Cancers, Vol. 11, No. 8, 1068, 01.08.2019.

Research output: Contribution to journalArticle

Chen, Li Tzong ; Macarulla, Teresa ; Blanc, Jean Frédéric ; Mirakhur, Beloo ; de Jong, Floris A. ; Belanger, Bruce ; Bekaii-Saab, Tanios ; Siveke, Jens T. / Nomogram for predicting survival in patients treated with liposomal irinotecan plus fluorouracil and leucovorin in metastatic pancreatic cancer. In: Cancers. 2019 ; Vol. 11, No. 8.
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abstract = "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.",
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AU - Siveke, Jens T.

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