Abstract 344P
Background
Recently, the liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) regimen is recommended as subsequent lines of chemotherapy. However, little is known about the predictive factors for the nal-IRI + 5-FU/LV regimen, especially in patients with previous irinotecan (IRI) exposure. Therefore, this multicenter, retrospective study investigated the predictive factors associated with nal-IRI + 5-FU/LV treatment in patients with PDAC.
Methods
The electronic medical records were obtained from four academic tertiary hospitals. Furthermore, subgroup analysis was conducted on patients who underwent UGT1A1 test.
Results
Overall, 268 patients were treated with nal-IRI + 5-FU/LV. The median overall survival (OS) was 7.9 months (95% confidence interval [CI]: 7.0–8.8), while the median progression-free survival (PFS) was 2.6 months (95% CI: 1.9–3.2). An albumin level <4.0 g/dL, neutrophil-to-lymphocyte ratio (NLR) ≥3.5, liver or peritoneal metastasis, and a history of >3 lines of palliative chemotherapy were associated with worse OS. An NLR of ≥3.5 and liver metastasis were significant predictive factors for worse PFS. Previous exposure to IRI was not a significant predictor. Patients without prior IRI treatment showed the longest OS and PFS compared with IRI responders and non-responders. Notably, no significant difference was observed in median OS and PFS between IRI responders and no-IRI treatment (P = 0.388 and P = 0.126). UGT1A1 genotype testing was conducted in 79 (29.5%) patients. In subgroup analysis, patients classified as extensive metabolizers plus intermediate metabolizers experienced longer OS and PFS compared to patients as poor metabolizers (OS: 8.8 vs. 3.4 months, P = 0.003; PFS: 2.8 vs. 2.0 months, P = 0.054). However, UGT1A1 status did not emerge as a significant predictor in the multivariate analysis using the Cox regression model, even though it appeared significant in the univariate analysis.
Conclusions
An NLR of ≥3.5 and liver metastasis were associated with worse PFS. Prior IRI exposure was not a significant predictive factor for OS and PFS, especially in IRI responders.
Legal entity responsible for the study
The authors.
Funding
Servier.
Disclosure
S. Bang: Financial Interests, Funding: Servier. All other authors have declared no conflicts of interest.