Clinical Outcomes Among Patients With Metastatic Pancreatic Ductal Adenocarcinoma Treated With Liposomal Irinotecan.

BACKGROUND

The NAPOLI-1 trial demonstrated that liposomal irinotecan in combination with fluorouracil (5-FU) and leucovorin (LV) prolonged survival with a manageable safety profile in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. Real-world data on clinical outcomes associated with liposomal irinotecan in NAPOLI-1-based regimens is needed to further substantiate this.

METHODS

This real-world, retrospective chart review study included patients with mPDAC who received NAPOLI-1-based regimens from six academic centers in the United States. Liposomal irinotecan initiation defined the index date. Overall survival (OS) and progression-free survival (PFS) were assessed with Kaplan-Meier methodology.

RESULTS

There were 374 patients evaluated; median age was 68 years, and 51% were female. Among 326 patients with baseline ECOG information, approximately 74% had ECOG score <2. Liposomal irinotecan was administered as a doublet with 5-FU in a NAPOLI-1-based regimen in the first line (1L; 16%), 2L (42%), and 3L+ (42%) of the metastatic setting. For patients treated in 1L, 2L, and 3L+, median [95% confidence interval (CI)] OS was 8.0 [5.1, 11.2], 7.3 [5.3, 8.8], and 4.6 [4.0, 5.7] months, and median [95% CI] PFS was 4.2 [2.2, 6.6], 3.0 [2.6, 3.7], and 2.0 [1.7, 2.2] months, respectively.

CONCLUSIONS

Patients in a real-world setting treated with NAPOLI-1-based liposomal irinotecan doublet regimens at academic centers were older with poorer performance status compared to trial patients yet had similar outcomes and efficacy. Furthermore, liposomal irinotecan was frequently used in the 3L+ setting where no treatment has been approved and provided clinical benefit.

Informations de copyright

Copyright © 2021 Yu, Hendifar, Alese, Draper, Abdelrahim, Burns, Khan, Cockrum, Bhak, Nguyen, DerSarkissian, Duh and Bahary.

Déclaration de conflit d'intérêts

KHY: Research Funding (BMS, Ipsen, Halozyme); Advisory Board (Ipsen). AEH: Consulting or Advisory Role (Novartis, Ipsen, Perthera, Celgene, Abbvie); Research Funding (Ipsen); Travel, Accommodations, Expenses (Halozyme). OBA: Research Funding (Taiho Oncology, Ipsen Pharmaceuticals, GSK, Bristol Myers Squibb, PCI Biotech AS, Calithera Biosciences, Inc., SynCore Biotechnology Co., Ltd., Corcept, Mabspace Biosciences); Consulting/Advisory Role (Exelixis, Conjupro BioTherapeutics, R-Pharm US LLC, Ipsen Pharmaceuticals, Natera, Taiho, Pfizer, QED therapeutics). MA: Advisory Board and Speaker (Ipsen). NB: Consultant (AstraZeneca, Exelixis, BMS, Thermo Fisher). PC is an employee of Ipsen Biopharmaceuticals, Inc. and owns stock/stock options. MSD, MD, RHB, and CN are employees of Analysis Group Inc., which has received consultancy fees from Ipsen Biopharmaceuticals, Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.