nal-IRI + 5FU/LV therapy demonstrated significant survival improvement in mPC pts previously treated with gemcitabine-based therapy (NAPOLI-1). The generally recommended nal-IRI initiation dose is 70 mg/m2 (free base, equivalent to 80 mg/m2 salt based dosing). This retrospective observational analysis describes the real-world dosing patterns of nal-IRI.
Using the Flatiron Health® longitudinal database, data was extracted and analyzed for adult pts with mPC treated with nal-IRI between Nov 2015 to Aug 2017. Dose intensity (DI) over the first 6 weeks of treatment, dose modifications anytime (mods), and overall duration of exposure (DOE) to nal-IRI were assessed. All dosing is expressed in terms of the free base.
257 mPC pts (median age: 67y; IQR 61–74) treated with nal-IRI were identified; DI was calculated for 231 pts with available dose, height, and weight data. Mean DI was 177.8 mg/m2 (SD: 74.9 mg/m2). Median DOE was 7.3 (IQR: 3.4 – 17.1) weeks (wks). Median dose at initiation was 69.4 (IQR 56.7–70.2) mg/m2. Stratified into groups based on median DI (190 mg/m2), more pts below median DI initiated at a lower dose (LD) (30 - 65 mg/m2) compared to the pts at/above the median DI (44.4% vs 13.8%). Pts below median DI were also older: median age 70y (IQR 63 - 76) vs 65y (IQR 61 - 72). Mean DI was similar for pts who initiated nal-IRI in 1st/2nd line (176.4 mg/m2; n = 131) vs later lines (179.6 mg/m2; n = 100). In 1st/2nd line pts, median DOE was 8.9 (IQR: 3.1 – 19) wks vs 6.3 (IQR :3.4 – 12.1) wks in 3rd+ line. Median DOE in pts initiated at the recommended dose of 65-75 mg/m2 (n = 152) was 8.1 wks. DOE in LD (n = 67) and higher dose (75–90 mg/m2; n = 11) pts was 7.1 and 6.1 wks, respectively. 27.2% of pts experienced a dose mod (18.3% in 1st/2nd line; 8.9% in 3rd+ line). Pts with dose mods had a median DOE of 13.1 vs 6.1 wks in pts without mods.
This real-world analysis showed similar DI results to the NAPOLI-1 trial, while dose mods were slightly lower. Pts with higher DI had longer DOE. Pts who experienced a dose mod, initiated nal-IRI in 1st/2nd line, were at/above median DI had, on average, longer DOE. Larger pt cohort analyses will elucidate dosing patterns and outcomes in nal-IRI treated pts.
Clinical trial identification
Legal entity responsible for the study
D. Ahn: Advisory board: Eisai. A. Surinach, F.A. Corvino: Employee: Genesis Research that received funding from Ipsen Biopharmaceuticals to conduct study. A. Valderrama, S. Pulgar: Employee: Ipsen Biopharmaceuticals. K. Mamlouk: Consultant: Ipsen Biopharmaceuticals. All other authors have declared no conflicts of interest.