A survival prediction nomogram for liposomal irinotecan (nal-IRI)+5-fluorouracil/leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy

[[abstract]]Background: NAPOLI-1 (NCT01494506) was a global phase 3 study in pts with mPDAC previously treated with gemcitabine-based therapy that showed a significant improvement in overall survival (OS) in pts treated with nal-IRI+5-FU/LV vs 5-FU/LV alone. A nomogram assists in predicting individualized risk for prespecified events, such as OS, death, or adverse events. A post hoc analysis of NAPOLI-1 was conducted to develop a nomogram to predict OS for nal-IRI+5-FU/LV in the post-gemcitabine setting. Methods: In NAPOLI-1, pts received nal-IRI+5-FU/LV, nal-IRI, or 5-FU/LV. Univariate and multivariate analyses identified baseline factors that were significantly predictive of OS. A multivariable Cox regression model was created to develop a nomogram that assigned points equal to the weighted sum of relative significance of each variable. The predictive accuracy of the nomogram, as measured by the concordance index (c-index), was evaluated by internal bootstrap validation. Results: Data from pts in the univariate analysis (n = 417) and multivariate analysis (n = 399; n = 18 pts excluded for missing data) were used. Eight of 21 variables were retained in the multivariate analysis and re-tested through stratification (all factors significant at the P < 0.01 level, except BMI [P= 0.08]). Conclusions: Key predictors of OS in NAPOLI-1 were nal-IRI+5-FU/LV treatment, KPS, NLR, albumin level, baseline CA19-9, stage 4 at diagnosis, BMI, and presence of liver metastasis