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
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 OSa | HR | 95% CI |
---|---|---|
Karnofsky Performance Status (KPS) ≥ 90 | 0.58 | 0.45, 0.73 |
Albumin ≥ 4 g/dL | 0.70 | 0.55, 0.89 |
Neutrophil-to-lymphocyte ratio (NLR) > 5 | 0.61 | 0.47, 0.78 |
Presence of liver metastases | 1.72 | 1.33, 2.24 |
CA19-9 > median (1542 U/mL) | 1.59 | 1.26, 2.01 |
Stage 4 at diagnosis | 1.61 | 1.27, 2.04 |
Received nal-IRI + 5-FU/LV | 0.60 | 0.46, 0.78 |
Body mass index (BMI) | 0.98 | 0.95, 1.00 |
aStepwise multivariate analysis with p < 0.10 for model entry and p < 0.10 for model retention.
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Abstract Disclosures
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