Abstract 1564P
Background
FOLFIRINOX (FFX), gemcitabine plus nab-paclitaxel (gem-nabP), and gemcitabine monotherapy (gem mono) are included in select clinical pathways and listed as category 1 (cat 1) treatment recommendations by the NCCN guidelines for patients (pts) with mPDAC and good performance status (PS) in the first line (1L) setting. This study describes the patient characteristics and overall survival (OS) of 1L pts with mPDAC treated with NCCN cat 1 regimens in a real-world setting.
Methods
Data for pts diagnosed with mPDAC between 1-1-15 and 12-31-19, treated in 1L with FFX, gem-nabP, or gem mono were analyzed from the Flatiron Health EHR Database. Patient age and ECOG PS, and duration of treatment (DOT) were described. Median OS from treatment initiation was derived using Kaplan-Meier analysis.
Results
Of the 4,371 pts identified, 32.5% (n=1,420) received FFX, 56.8% (n=2,484) received gem-nabP, and 10.7% (n=467) received gem mono in 1L. The median age at treatment initiation was 64 years (IQR: 57 – 70), 70y (63 – 76), and 75y (67 – 80) for pts who received FFX, gem-nabP, and gem-mono, respectively (p < 0.0001). Gem mono treated pts accounted for 14.6% of 1L pts treated with the 3 regimens in 2015 and for 7.8% of pts in 2019. ECOG PS of 0-1 were reported for 63.0%, 59.3%, and 39.8% of pts who received FFX, gem-nabP, and gem mono, respectively; ECOG PS of 2+ were reported for 7.5%, 14.8%, and 31.5% of pts treated with FFX, gem-nabP, and gem mono, respectively (p < 0.0001). Median DOT was 12.0 weeks (IQR: 4.1 – 26.5), 10.9 wks (3.0 – 23.0), and 4.0 wks (1.0 – 11.0) for pts who received FFX, gem-nabP, and gem mono, respectively (p < 0.0001). Median OS was 9.4 months (95% CI: 8.7 – 10.1), 6.6 mos (95% CI: 6.2 – 7.0), and 3.7 mos (95% CI: 3.2 – 4.5) for pts treated with FFX, gem-nabP, and gem mono, respectively (p <0.0001).
Conclusions
Pts treated with gem mono were older, had worse PS, and shorter DOT than those pts treated with FFX or gem-nabP. Pts treated with gem mono also experienced significantly worse survival outcomes than those receiving these comparator 1L regimens. Further clinical pathway evaluation of gem mono is suggested.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
G. Kim: Speaker Bureau/Expert testimony: Ipsen. P. Cockrum: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. S. Arndorfer: Advisory/Consultancy, Work for Genesis Research which receives funding from Ipsen: Ipsen. A. Surinach: Advisory/Consultancy, Work for Genesis Research which receives funding from Ipsen: Ipsen.