Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jul 28;11(8):1068.
doi: 10.3390/cancers11081068.

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

Li-Tzong Chen  1   2 , Teresa Macarulla  3 , Jean-Frédéric Blanc  4 , Beloo Mirakhur  5 , Floris A de Jong  6 , Bruce Belanger  7 , Tanios Bekaii-Saab  8 , Jens T Siveke  9   10
Affiliations

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

Li-Tzong Chen et al. Cancers (Basel). .

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.

Keywords: NAPOLI-1; liposomal irinotecan; nomogram; pancreatic cancer; survival outcomes.

PubMed Disclaimer

Conflict of interest statement

L.-T.C.: Consulting/Advisory Role: Bristol-Myers Squibb; Five Prime Therapeutics; Lilly; Merrimack; MSD; Novartis; Ono Pharmaceutical; PharmaEngine; Syncope, Taiwan; TTY Biopharm. Research Funding: GlaxoSmithKline (Inst); Merck Serono (Inst); Novartis (Inst); Polaris (Inst); TTY Biopharm (Inst). Patents, Royalties, Other Intellectual Property: anti-alpha-enolase (ENO-1) monoclonal antibody to HuniLife Technology, Taiwan. T.M.: Nothing to disclose. J.-F.B.: Honoraria: Baxalta/Shire; Bayer Schering Pharma; Gilead Sciences. Consulting/Advisory Role: Baxalta/Shire; Bristol-Myers Squibb; Novartis; Onxeo. Travel, Accommodations, Expenses: Bayer Schering Pharma. B.M.: Employed at Ipsen; Stock and Other Ownership Interests with Bristol-Myers Squibb. F.A.d.J.: Employed at Servier; Stock and Other Ownership Interests with Shire. B.B.: Employed at Ipsen and Merrimack. T.B.-S.: Consulting/Advisory Role: AbbVie. Other Relationship (DSMB): Exelixis; Silajen, Armo and Merck. J.T.S.: Consulting/Advisory Role: Baxalta; Celgene; Lilly; Shire. Research Funding: 4SC; Bristol-Myers Squibb; Celgene. Travel, Accommodations, Expenses: Celgene; Roche; Shire. The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Statistical analysis plan.
Figure 2
Figure 2
Nomogram to predict overall survival in patients with metastatic pancreatic cancer treated with nal-IRI+5-FU/LV in the NAPOLI-1 study. 5-FU/LV, 5-fluorouracil/leucovorin; CA19-9, cancer antigen 19-9; nal-IRI, liposomal irinotecan.
Figure 3
Figure 3
Kaplan‒Meier survival curves showing overall survival probability stratified by risk group.
Figure 4
Figure 4
Nomogram to predict overall survival in patients with metastatic pancreatic cancer in the NAPOLI-1 study excluding treatment arm. CA19-9, cancer antigen 19-9.
See this image and copyright information in PMC

References

    1. World Health Organization-International Agency for Research on Cancer (IARC) GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. [(accessed on 10 October 2018)]; Available online: http://gco.iarc.fr/today/home.
    1. Rahib L., Smith B.D., Aizenberg R., Rosenzweig A.B., Fleshman J.M., Matrisian L.M. Projecting Cancer Incidence and Deaths to 2030: The Unexpected Burden of Thyroid, Liver, and Pancreas Cancers in the United States. Cancer Res. 2014;74:2913–2921. doi: 10.1158/0008-5472.CAN-14-0155. - DOI - PubMed
    1. Malvezzi M., Bertuccio P., Levi F., La Vecchia C., Negri E. European cancer mortality predictions for the year 2014. Ann. Oncol. 2014;25:1650–1656. doi: 10.1093/annonc/mdu138. - DOI - PubMed
    1. SEER Cancer Statistics Factsheets: Pancreatic Cancer National Cancer Institute. [(accessed on 12 October 2018)]; Available online: http://seer.cancer.gov/statfacts/html/pancreas.html.
    1. Siegel R.L., Miller K.D., Jemal A. Cancer statistics, 2018. CA A Cancer J. Clin. 2018;68:7–30. doi: 10.3322/caac.21442. - DOI - PubMed

LinkOut - more resources