184P - Neutropenia as a predictive and prognostic factor in nanoliposomal-irinotecan/fluorouracil/leucovorin therapy for pancreatic cancer: Findings from the NAPOLEON-2 study (NN-2301)

Background

Pancreatic cancer remains a highly lethal malignancy with limited treatment options for metastatic and recurrent cases. Nanoliposomal-irinotecan and fluorouracil with leucovorin (NFF) has emerged as the standard treatment following gemcitabine-based regimens. However, the relationship between treatment outcomes and neutropenia in pancreatic cancer has not been thoroughly investigated.

Methods

In this retrospective study, we analyzed data from 161 patients with pancreatic cancer treated with NFF. Neutropenia was assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) cutoffs: Cutoff A (CTCAE Grade 0 versus Grade 1–4), Cutoff B (Grade 0–1 versus Grade 2–4), and Cutoff C (Grade 0–2 versus Grade 3–4). The primary endpoint was overall survival (OS), while secondary endpoints included response rate (RR), progression-free survival (PFS), and relative dose intensity (RDI).

Results

Among the 161 patients, 93/8/22/30/8 had Grade 0/1/2/3/4 neutropenia, respectively. Baseline patient characteristics, including white blood cell (WBC) count, neutrophil count, lymphocyte count, C-reactive protein (CRP) levels, and FU RDI, exhibited significant differences (p<0.05) between two groups separated by Cutoff A and Cutoff B. Additionally, WBC count, neutrophil count, and FU RDI differed significantly (p<0.05) at Cutoff C. Fisher’s exact test revealed significant differences (p<0.05) in RR at Cutoff C, with the odds ratio of Cutoff C being the greatest, followed by Cutoff B and A. Regarding OS, there were significant differences at Cutoff A (hazard ratio (HR), 0.65; 95% CI, 0.44–0.94; p<0.05) and Cutoff B (HR, 0.63; 95% CI, 0.43–0.92; p<0.05), but not at Cutoff C (HR, 0.73; 95% CI, 0.47–1.14; p=0.16). Furthermore, there were significant differences in PFS at Cutoff A and B (p<0.05). Cox regression analysis indicated that neutropenia was significantly associated with OS at Cutoff A and B (adjusted p<0.05).

Conclusions

NFF-induced neutropenia exhibits significant potential as both a predictive factor for treatment response and a prognostic factor for OS in patients with pancreatic cancer.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.