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

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/m

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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.