Abstract 1513P
Background
The most common reasons for treatment discontinuation (d/c) among patients treated in the liposomal irinotecan + 5-fluorouracil/ leucovorin (5-FU/LV) arm of the NAPOLI-1 study, a randomized phase 3 study in pts with mPDAC previously treated with gemcitabine-based therapy, were disease progression (55.3%), patient decision (13.6%), and clinical deterioration (12.6%). Real-world (RW) data lack detailed information regarding reasons for d/c of systemic treatment. This study examined the characteristics and reasons for treatment d/c of pts with mPDAC treated with liposomal irinotecan.
Methods
This retrospective study used the Flatiron Health EHR-derived database. Data were analyzed for adult pts with mPDAC treated with liposomal irinotecan-based regimens between January 2016 and October 2020. Pt and clinical characteristics evaluated included age, sex, stage, and the number of prior lines of therapy at the time of treatment initiation. Reasons for treatment d/c were abstracted from patient records.
Results
675 pts (median age: 69 years (IQR: 62 – 75)) with mPDAC treated with a liposomal irinotecan-based regimen were included. 54% were initially diagnosed with stage IV disease, 52% were male, and 62% initiated liposomal irinotecan in the 1L or 2L setting. Across all lines of therapy, there were 555 patients with at least one reason for d/c recorded. Progression was the most common reason recorded (n=317, 57.1%), followed by toxic effect of therapy (n=102, 18.4%), disease related symptoms not due to therapy (n=92, 16.6%), and patient request (n=35, 6.3%).
Conclusions
In this RW study of patients with mPDAC treated with a liposomal irinotecan-based regimen, progression while on therapy was the most common reason cited for treatment d/c similar to the pivotal phase 3 trial. The proportion of d/cs due to patient requests was smaller in the RW than in the trial (6.3% vs 13.6%); disease related symptoms/clinical deterioration were similar (16.6% vs 12.6%) and toxic effects of therapy/adverse events were higher in the RW (18.4% vs 9.4%). Further studies are needed to understand the clinical context that leads patients to discontinue treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
G. Kim: Financial Interests, Personal, Advisory Role: Ipsen. A. Surinach: Financial Interests, Institutional, Advisory Role: Ipsen. S. Wang: Financial Interests, Institutional, Advisory Role: Ipsen. N. Lamarre: Financial Interests, Institutional, Advisory Role: Ipsen. P. Cockrum: Financial Interests, Personal, Full or part-time Employment: Ipsen; Financial Interests, Personal, Stocks/Shares: Ipsen.