Abstract 1534P
Background
Pancreatic cancer is the fourth most lethal cancer in Europe. Liposomal irinotecan is indicated, in combination with 5-fluorouracil and leucovorin, for pts with mPDAC following disease progression with gemcitabine-based therapy. This study examines the survival outcomes associated with DRs among pts with mPDAC treated with liposomal irinotecan.
Methods
This retrospective observational study utilized the Flatiron Health EHR-derived de-identified database from over 280 cancer clinics in the US. Data were analyzed for adult pts with mPDAC treated with liposomal irinotecan based regimens between Nov 2015 and Oct 2019. Pts were categorized into two starting dose groups: 70mg/m2 (indicated dose) or <65mg/m2 (cut off for DR). Pt characteristics, overall survival (OS), and impact of DRs (reduction ≥ 7mg/m2) were assessed among pts who received ≥3 cycles of treatment (tx). Unadjusted and multivariable time-dependent Cox proportional hazards models were used to assess the impact of DRs on OS.
Results
Of 348 pts (median age 69y, 43 – 85), 116 (33%) pts had two or more prior lines of tx, 209 (60%) had an ECOG score of 0-1, 48 (14%) had an ECOG score of 2+, and 91 (26%) had missing scores. 220 (63%) initiated tx at 70mg/m2 and 128 (37%) initiated at <65mg/m2. 83 (38%) 70mg/m2 and 26 (20%) <65mg/m2 pts experienced a DR. Among pts who initiated at 70mg/m2, those with a DR had an mOS (95% CI) of 8.9 mos (7.3 – 10.8) and those without a DR had an mOS of 6.0 mos (4.8 – 7.2) [HR: 0.78 (0.56 – 1.09), adjusted HR: 0.77 (0.55 – 1.08)]. For pts who initiated at <65mg/m2, mOS was 7.7 mos (5.0 – 14.9) for pts with a DR and 6.0 mos (4.7 – 7.2) for pts without [HR: 0.93 (0.55 – 1.56), adjusted HR: 0.83 (0.46 – 1.49)]. ECOG score (2+) and prior lines of tx (≥2) were associated with reduced survival among pts receiving 70mg/m2 or <65mg/m2, respectively.
Conclusions
In this real-world study of patients with mPDAC treated with a liposomal irinotecan based regimen for ≥3 cycles, DRs were associated with lower risks of death, though not statistically significant. Further studies are needed to characterize factors that influence clinical outcomes among liposomal irinotecan pts who receive DRs.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
L. Abushahin: Advisory/Consultancy: Bionest. P. Cockrum, B. Belanger: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. A. Surinach: Advisory/Consultancy, Work for Genesis Research which receives funding from Ipsen: Ipsen.