The prognostic value of the modified glasgow prognostic score (mGPS) in predicting overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving liposomal irinotecan (nal-IRI)+5-fluorouracil and leucovorin (5-FU/LV) (2018)

Background: mGPS has been identified as a prognostic factor of OS in patients with pancreatic cancer. Here we report the association between mGPS and OS in a post-hoc analysis of the NAPOLI-1 study (NCT01494506), which demonstrated improved survival for nal-IRI+5-FU/LV vs 5-FU/LV in the treatment of patients with mPDAC previously treated with gemcitabine-based therapy. Methods: All patients treated in the NAPOLI-1 study with available baseline plasma Creactive protein (CRP) and albumin data (data cutoff: Nov 16, 2015) were included in this post-hoc analysis. Eligible patients were stratified by mGPS (mGPS-0: CRP ≤10 mg/L regardless of albumin level; mGPS-1: CRP >10 mg/L, albumin ≥35 g/L; and mGPS-2: CRP >10 mg/L, albumin <35 g/L). OS was assessed in individual and pooled treatment arms. A stepwise Cox regression model of OS was used to evaluate the prognostic significance of mGPS. Results: Baseline plasma C-reactive protein and albumin data was available for N = 184 patients: mGPS-0, n = 79; mGPS-1, n = 88; mGPS-2, n = 17. For patients in pooled treatment arms, median OS was worse for the mGPS-1 group than for the mGPS-0 group (4.0 vs 8.0 months, respectively), but was comparable between the mGPS-2 and mGPS-1 groups (3.2 vs 4.0 months, respectively). Multivariate analysis revealed both mGPS-1 and mGPS-2 were independent predictive factors of death (mGPS-1: HR, 3.34; 95% CI, 2.25–4.95, P < 0.0001; mGPS-2: HR, 5.89; 95% CI, 3.21–10.80, P < 0.001). Similarly, analysis by treatment arm showed OS of patients treated with nal-IRI+5-FU/LV was significantly worse in the mGPS-1 (N = 26) and mGPS-2 (N = 5) groups than in the mGPS-0 (N = 27) group (4.6, 3.3 vs 9.3 months, respectively) Conclusions: Data from this post-hoc analyses of mGPS in patients with mPDAC previously treated with gemcitabine-based are consistent with the reports of the prognostic value of the mGPS in estimating OS. Median OS was significantly improved in pts with a mGPS-0 vs mGPS-1 or mGPS-2, including the treatment group of patients receiving nal-IRI+5-FU/LV. Clinical trial identification: NCT01494506. Editorial acknowledgement: Editorial assistance was provided by The Medicine Group (New Hope, PA, USA); Philip Sjostedt, BPharm; Susan Martin, PhD. Legal entity responsible for the study: Ipsen Biopharmaceuticals, Inc. Funding: Ipsen Biopharmaceuticals, Inc. Disclosure: L-T. Chen: Consulting or advisory role: Bristol-Myers Squibb, Five Prime Therapeutics, Lilly, Merrimack, MSD, Novartis, Ono Pharmaceutical, PharmaEngine, Syncope, Taiwan, TTY Biopharm; Research funding (Inst): GlaxoSmithKline, Merck Serono, Novartis, Polaris, TTY Biopharm; Patents, Royalties, Other intellectual property: Anti-alpha-enolase (ENO-1) monoclonal antibody to HuniLife Technology, Taiwan. B. Belanger, B. Mirakhur: Employee stock, Other ownership interests: Ipsen Biopharmaceuticals, Inc. F.A. de Jong: Employee: Shire Stock, Other ownership interests: Amgen, Shire. J. Siveke: Consulting, Advisory role: Baxalta, Celgene, Lilly, Merrimack; Research funding: 4SC; Boehringer Ingelheim, Bristol-Myers Squibb, Celgene;, Novartis, Travel, accommodations, expensive: Celgene, Roche. All other authors have declared no conflicts of interest.