Abstract 1555P
Background
Liposomal irinotecan in combination with fluorouracil (5-FU) and leucovorin (LV) extended survival with a manageable safety profile in patients with mPDAC who previously received gemcitabine-based therapy in the NAPOLI1 trial. Limited data are available on the efficacy and use of liposomal irinotecan for mPDAC in routine clinical practice. This retrospective multi-center chart review assessed real-world (rw) characteristics and outcomes of patients in the US who received NAPOLI1 trial-based regimens.
Methods
Patients with mPDAC treated with liposomal irinotecan were eligible. Liposomal irinotecan initiation defined index date, with duration of therapy, clinical characteristics, and treatment patterns reported. Rw overall survival (rwOS) and progression-free survival (rwPFS) were assessed with Kaplan-Meier methods. Six large cancer centers were included.
Results
216 patients were initially assessed; median age was 68 years and 54% were female. 13% of patients had ECOG of 0, 53% had ECOG 1, and 20% had ECOG ≥2. Liposomal irinotecan was received in a doublet with 5-FU in a NAPOLI1-based regimen, with 70% receiving LV. Patients received liposomal irinotecan in first-line (1L; 17%), 2L (43%), and 3L+ (40%). Prior regimens were gemcitabine-based (80%) or contained 5-FU (27%). Median duration of therapy was 1.8, 1.7, and 1.4 months for 1L, 2L, and 3L+, respectively. Starting dose was commonly 70 mg/m2 (47%), and 30% had dose modification. Median rwOS and rwPFS are shown in the table. Table: 1555P
rwOS and rwPFS among Patients Treated with Liposomal Irinotecan in a NAPOLI1-based regimen
| rwOS | N | Median (95% CI), months |
| 1L | 37 | 8.8 (4.4, 13.2) |
| 2L | 93 | 7.4 (5.3, 9.0) |
| 3L+ | 86 | 4.9 (3.8, 6.4) |
| rwPFS | ||
| 1L | 37 | 2.7 (2.3, 3.0) |
| 2L | 93 | 3.0 (2.6, 3.9) |
| 3L+ | 86 | 2.2 (1.8,. 2.8) |
Conclusions
Patients treated with a doublet liposomal irinotecan in a NAPOLI1-based regimen in academic centers are older with poorer prognosis based on ECOG compared to the trial; however, rw effectiveness is comparable. In addition, liposomal irinotecan is frequently used in 3L+ where no treatment has been approved, providing reasonable benefit.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
K.H. Yu: Advisory/Consultancy: Ipsen; Research grant/Funding (self): Ipsen, Bristol-Myers Squibb, Halozyme. A. Hendifar: Advisory/Consultancy: Novartis, Ipsen, Perthera, Celgene, Abbvie; Travel/Accommodation/Expenses: Halozyme; Research grant/Funding (self): Ipsen. O. Alese: Advisory/Consultancy: Exelixis, AstraZeneca, Conjupro Biotherapeutics, Ipsen; Travel/Accommodation/Expenses: Exelixis; Research grant/Funding (institution): Bristol-Myers Squibb, Five Prime Therapeutics, Acetylon Pharmaceuticals, Tesaro, Ipsen, Taiho Pharmaceutical. A. Draper: Advisory/Consultancy: Array Biopharma; Honoraria (self): Wellstat Therapeutics. M. Abdelrahim: Advisory/Consultancy: Ipsen; Speaker Bureau/Expert testimony: Ipsen. G. Khan: Honoraria (self), Travel/Accommodation/Expenses: Bayer, Eisai; Advisory/Consultancy: Bayer, Celgene, Eisai. P. Cockrum: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. R. Bhak: Research grant/Funding (institution): Janssen Scientific Affairs, Novartis, GSK, Takeda, Pfizer, Bayer, Seattle Genetics, Ipsen, Mallinckrodt. C. Nguyen: Research grant/Funding (institution): GSK, Ipsen, Sanofi Pasteur, Celgene, Taiho Oncology, Takeda, Shire, Vertex, Janssen, Merck, Kiniksa, Intercept, AstraZeneca, Novo Nordisk, Novartis, Pfizer. M. DerSarkissian: Research grant/Funding (institution): AstraZeneca, Novartis, Pfizer, GSK, Takeda, Novo Nordisk, Ipsen, Sanofi/Regeneron, Janssen, Kiniksa, LivaNova, Merck, Medtronic, Mallinckrodt, Seattle Genetics, ViiV. M.S. Duh: Advisory/Consultancy: Seattle Genetics, Sanofi, Taris, Alexion; Research grant/Funding (institution): Ipsen, Taiho, Merck, Novartis, Pfizer. N. Bahary: Advisory/Consultancy: Celgene, Bristol-Myers Squibb, AstraZeneca, Exelixis, Thermo Fisher Scientific. All other authors have declared no conflicts of interest.