Abstract 2658
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.
Legal entity responsible for the study
Ipsen Biopharmaceuticals, Inc.
Funding
Ipsen Biopharmaceuticals, Inc.
Editorial Acknowledgement
Editorial assistance was provided by The Medicine Group (New Hope, PA, USA); Philip Sjostedt, BPharm; Susan Martin, PhD.
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.
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