Nomogram for predicting overall survival (OS) in patients (pts) treated with liposomal irinotecan (nal-IRI) ± 5-fluorouracil/leucovorin (5-FU/LV) in metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy in NAPOLI-1.

Authors

Andrea wang-gillam

Andrea Wang-Gillam

Washington University School of Medicine in St. Louis, St. Louis, MO

Andrea Wang-Gillam , Richard Hubner , Beloo Mirakhur , Floris A de Jong , Bruce Belanger , Li-Tzong Chen

Organizations

Washington University School of Medicine in St. Louis, St. Louis, MO, Christie NHS Foundation Trust, Manchester, United Kingdom, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, Shire GmbH, Zug, Switzerland, Ipsen Bioscience, Inc., Cambridge, MA, National Health Research Institutes/ National Institute of Cancer Research, Tainan, Taiwan

Research Funding

Pharmaceutical/Biotech Company

Background: Results from NAPOLI-1 (NCT01494506), a phase 3 study in pts with mPDAC previously treated with gemcitabine-based therapy, demonstrated an improvement in OS (primary endpoint), progression-free survival, and objective response rate with nal-IRI+5-FU/LV vs 5-FU/LV. The MPACT study reported a nomogram to predict OS using baseline pt variables in previously untreated mPDAC. We conducted an exploratory post hoc analysis of NAPOLI-1 variables to develop a nomogram to predict OS in the post-gemcitabine setting. Methods: In NAPOLI-1, pts were randomized to receive nal-IRI 80 mg/m2 q2w + 5-FU/LV, nal-IRI 100 mg/m2 q3w, or 5-FU/LV. Univariate and multivariate analyses determined factors significantly predictive of OS. A multivariable Cox model was created using these factors to develop a nomogram that assigned points equal to the weighted sum of relative significance of each variable. Predictive accuracy of the nomogram as measured by the concordance index (c-index) was evaluated by internal bootstrap validation. Results: Data from the 417-pt univariate analysis and 399-pt multivariate analysis (18 pts excluded for missing baseline data) were used. Eight of 21 variables were retained in the multivariate analysis (p < 0.01 except BMI [p=0.08]). Conclusions: In NAPOLI-1, predictors of OS were nal-IRI+5-FU/LV treatment, KPS, NLR, albumin level, baseline CA19-9, stage 4 at diagnosis, BMI, and presence of liver metastasis. The nomogram, which will distinguish between risk groups and may aid in clinical decision making, will be presented in the poster. Clinical trial information: NCT01494506

Multivariate Cox Model for OSaHR95% CI
Karnofsky Performance Status (KPS) ≥ 900.580.45, 0.73
Albumin ≥ 4 g/dL0.700.55, 0.89
Neutrophil-to-lymphocyte ratio (NLR) > 50.610.47, 0.78
Presence of liver metastases1.721.33, 2.24
CA19-9 > median (1542 U/mL)1.591.26, 2.01
Stage 4 at diagnosis1.611.27, 2.04
Received nal-IRI + 5-FU/LV0.600.46, 0.78
Body mass index (BMI)0.980.95, 1.00

aStepwise multivariate analysis with p < 0.10 for model entry and p < 0.10 for model retention.

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Abstract Details

Meeting

2018 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT01494506

Citation

J Clin Oncol 36, 2018 (suppl 4S; abstr 459)

DOI

10.1200/JCO.2018.36.4_suppl.459

Abstract #

459

Poster Bd #

M6

Abstract Disclosures