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Poster display session

1384 - Prognostic value of baseline neutrophil-to-lymphocyte ratio for predicting clinical outcome in metastatic pancreatic ductal adenocarcinoma (mPDAC) patients treated with liposomal irinotecan (nal-IRI) + 5-fluorouracil and leucovorin (5-FU/LV) vs 5-FU/LV alone

Date

09 Sep 2017

Session

Poster display session

Presenters

Richard Hubner

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

R.A. Hubner1, L. Chen2, C. Li3, G. Bodoky4, A. Dean5, K. Lee6, D. Cunningham7, J.T. Siveke8, F.S. Braiteh9, F.A. de Jong10, B. Belanger11, R. Walls11, P.D. Mody11, D.D. von Hoff12, A. Wang-Gillam13

Author affiliations

  • 1 Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 2 Oncology, National Health Research Institutes, 704 - Tainan/TW
  • 3 Gastroenterology And Hepatology, Taipei Veterans General Hospital, Taipei/TW
  • 4 Oncology, Egyesített Szent István és Szent László Kórház – Rendelőintézet, Budapest/HU
  • 5 Oncology, St John of God Hospital, Subiaco/AU
  • 6 Oncology, Seoul National University Hospital, 110-744 - Seoul/KR
  • 7 Gi And Lymphoma Research Unit, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 8 Solid Tumor Translational Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45122 - Essen/DE
  • 9 Oncology, Comprehensive Cancer Centers of Nevada, 89169 - Las Vegas/US
  • 10 Global Medical Affairs, Oncology, Shire, Zug/CH
  • 11 Medical Affairs, Oncology, Ipsen Biopharmaceuticals, Inc., Basking Ridge/US
  • 12 Oncology, Translational Genomics Research Institute, Phoenix/US
  • 13 Oncology, Washington University School of Medicine, St. Louis/US
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Resources

Abstract 1384

Background

Elevated baseline neutrophil-to-lymphocyte ratio (NLR), a marker of subclinical inflammation, is associated with poor survival in several malignancies including mPDAC. Here we report the association of NLR with overall survival (OS) and progression-free survival (PFS) in a post-hoc analysis of the NAPOLI-1 trial (NCT01494506), that demonstrated improved survival with nal-IRI+5-FU/LV vs 5-FU/LV for treatment of mPDAC patients (pts) after disease progression following gemcitabine-based therapy.

Methods

Pts treated with nal-IRI+5-FU/LV or 5-FU/LV and available baseline NLR data were included (data cutoff: Nov 16, 2015). OS and PFS were assessed in pts with high (>5) or low (≤5) baseline NLR in individual and pooled treatment arms.

Results

Baseline NLR was available for 221 pts: 116/117 nal-IRI+ 5-FU/LV pts and 105/105 5-FU/LV pts. In the pooled treatment arms, pts with NLR≤5 had significantly better OS compared to pts with NLR >5 (6.2 vs 3.7 months, HR = 0.7, p = 0.02). Interestingly, this improvement in OS in pts with low vs high NLR was significant in the nal-IRI+5-FU/LV arm (8.4 vs 4.3 months, HR = 0.5, p=0.001); but not in the 5-FU/LV arm (4.8 vs 3.1 months, HR = 0.9, p=0.6). Similarly, PFS was significantly higher in pts with NLR≤5 vs NLR >5 in the pooled treatment arms (2.7 vs 1.4 months, HR = 0.7, p=0.05), and the nal-IRI+5-FU/LV arm (4.2 vs 1.4 months, HR = 0.5, p=0.002), but not the 5-FU/LV arm (1.5 vs 1.4 months, HR = 1.1, p=0.6).Table:

741P

Pooled treatment armsnal-IRI + 5FU/LV5FU/LV
Baseline NLR≤5>5≤5>5≤5>5
(n = 155)(n = 66)(n = 82)(n = 34)(n = 73)(n = 32)
Median1 OS, months (95% CI)6.2 (5.2 - 7.6)3.7 (3.1 - 4.4)8.4 (6.1 - 10.2)4.3 (3.4 - 4.7)4.8 (3.6 - 6.1)3.1 (1.9 - 4.2)
HR20.70.50.9
95% CI0.5 - 0.90.3 - 0.80.6 - 1.4
P30.020.0010.6
Median1 PFS, months (95% CI)2.7 (2.4 - 3.3)1.4 (1.4 - 1.6)4.2 (3.1 - 5.6)1.4 (1.4 - 2.8)1.5 (1.4 - 2.6)1.4 (1.3 - 1.9)
HR20.70.51.1
95% CI0.5 - 1.00.3 - 0.80.8 - 1.8
P30.050.0020.6
1

Medians reflect Kaplan-Meier estimates

2

Hazard ratios (HRs) reflect Cox regression analysis.

3

Two-sided p-value < 0.05 considered statistically significant in these exploratory analyses

Conclusions

Data from these exploratory analyses are consistent with previous reports on the prognostic value of baseline NLR in mPDAC, and extend it to the post-gemcitabine setting. Median OS and PFS were improved in pts with low vs high baseline NLR in the nal-IRI+5-FU/LV arm but not in the 5-FU/LV arm. Clinical implications of these data remain to be determined.

Clinical trial identification

NCT01494506

Legal entity responsible for the study

Merrimack Pharmaceuticals, Inc.

Funding

Ipsen Biopharmaceuticals, Inc.

Disclosure

R.A. Hubner: Consulting for Celgene, BTQ, Baxalta. Speakers’ Bureau for Abbott, Ipsen. L-T. Chen: Consulting for ONO, Eli Lilly, MSD, PharmaEngine, Merrimack, TTY, Syncore, Five Prime, Novartis. Research funding from Novartis, GSK, TTY, Polaris. G. Bodoky: Honoraria from Servier, Roche, Bayer, Pfizer, Janssen, Novartis, Lilly. Advisory board of Bayer, Roche, Pfizer, Janssen, Novartis, Lilly, Taiho, Nordic. D. Cunningham: Research funding from Amgen, Astrazeneca, Bayer, Celgene, Merrimack, Medimmune, Merck Serono, Sanofi. J.T. Siveke: Research funding from Celgene, BMS, 4SC, Novartis, Boehringer. Consultant for Merrimack, Baxalta, Celgene, Eli Lilly. F.S. Braiteh: Consulting and speaking fees from Ipsen. F.A. de Jong: Employee and stockholder of Shire. B. Belanger, R. Walls, P.D. Mody: Employee of Ipsen Biopharmaceuticals, Inc. D.D. von Hoff: Research funding from Merrimack. A. Wang-Gillam: Research funding from Newlink, Astrazeneca, Biomed Valley, Eli Lilly, Abbvie, Verastem, Precision Biologics. Consulting for Merrimack, Pfizer, Newlink. All other authors have declared no conflicts of interest.

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