The NAPOLI-1 study, a randomized phase III study in pts with mPDAC previously treated with gemcitabine-based therapy, demonstrated an improvement in progression-free survival (PFS) with liposomal irinotecan + 5-fluorouracil/ leucovorin (5-FU/LV) vs. 5-FU/LV. Pts treated with liposomal irinotecan + 5-FU/LV in NAPOLI-1 had a median age of 63 years at treatment (tx) initiation, 97% had performance scores (PS) equivalent to ECOG 0-1, and 34% had at least 2 prior lines of therapy. This study examines the characteristics and real-world (rw) PFS of pts with mPDAC treated with liposomal irinotecan regimens.
This retrospective study utilized the Flatiron Health EHR-derived database. Data were analyzed for adult pts with mPDAC treated with liposomal irinotecan-based regimens between January 2016 and October 2020. Pt and clinical characteristics evaluated included age, sex, stage at diagnosis, ECOG PS, and the number of prior lines of therapy at the time of tx initiation. rwPFS was assessed from the start of tx until progression or death. Median rwPFS was derived utilizing Kaplan-Meier methods.
675 pts with mPDAC treated with a liposomal irinotecan-based regimen were included. Of these, 54% were initially diagnosed with stage IV disease, 52% were male, and 62% initiated liposomal irinotecan in the 1L or 2L setting. Median age at tx initiation was 69 (IQR: 62 – 75) years. 91.5% of pts were treated in the community setting. Among pts with available ECOG PS (n=509), 77.4% had a PS of 0-1 and 22.6% had a PS of 2+. Overall, median rwPFS was 2.8 mos [95%CI: 2.5–3.1]. Median rwPFS among pts treated in 1L (n=101), 2L (n=318), and third line plus (3L+, n = 254) were 3.8 mos [2.9–4.8], 3.2 mos [2.8–3.5], and 2.1 mos [1.9–2.3], respectively.
In this real-world study of pts with mPDAC treated with a liposomal irinotecan-based regimen, median rwPFS was similar to the median PFS of the pivotal phase III trial despite the fact that pts in the real-world were older, had worse performance scores, and more prior lines of therapy than pts included in the clinical trial. Further studies are needed to characterize factors that influence PFS among pts treated with liposomal irinotecan.
Clinical trial identification
Legal entity responsible for the study
G. Kim: Financial Interests, Personal, Advisory Role: Ipsen. P. Cockrum: Financial Interests, Personal, Full or part-time Employment: Ipsen; Financial Interests, Personal, Stocks/Shares: Ipsen. A. Surinach: Financial Interests, Institutional, Advisory Role: Ipsen. S. Wang: Financial Interests, Institutional, Advisory Role: Ipsen. N. Lamarre: Financial Interests, Institutional, Advisory Role: Ipsen.