https://meetinglibrary.asco.org/record/165000/abstract
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Background:The NAPOLI-1 study, a randomized phase 3 study in patients with mPDAC previously treated with gemcitabine-based therapy, demonstrated an improvement in overall survival (OS), progression-free survival (PFS), and objective response rate with nal-IRI + folinic acid/ leucovorin (5-FU/LV) vs. 5-FU/LV. In this analysis, we describe real world characteristics and outcomes of mPDAC pts treated with nal-IRI in the US.Methods:This retrospective observational study utilized data from Flatiron Health’s longitudinal database derived from electronic health records data from over 265 diverse cancer clinics. Patient characteristics, OS, time-to-treatment failure (TTF), and adverse events (AEs) abstracted from structured lab data were assessed in adult pts diagnosed with mPDAC who received nal-IRI treatment between November 18, 2015 and August 31, 2017.Results:Of the 257 mPDAC pts treated with nal-IRI, 51% were male, 28% had a pancreatectomy, and median age was 67 (IQR: 61-74). Among pts with an ECOG score recorded at nal-IRI initiation (n=189), 20% had an ECOG of 2 or greater. Following diagnosis of metastatic or recurrent disease, 57% of pts received nal-IRI in the first or second line, and 43% in third line or later. Median OS was 5.59 months [95% CI 4.83,7.33] for pts receiving nal-IRI as the first or second treatment (n=145) and 4.11 months [95% CI 3.38, 4.9] for those receiving it in third or later lines (n=112), respectively. TTF was 2.33 [1.64, 3.02] for those treated in first or second line, and 1.64 [1.38, 1.87] for those in third line or later. Among pts for whom reasons for discontinuation were available(n=186), disease progression (57%), disease-related symptoms (17%), and treatment toxicity (14%) were reported most often. Structured AEs were generally consistent with those reported in NAPOLI-1.Conclusions:In this real world US population with older median age and poorer performance status, median OS, TTF, and structured AEs were similar to those reported in NAPOLI-1. As would be expected, pts receiving nal-IRI treatment in earlier lines had a higher median OS.
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ASCO Annual Meeting