Abstract
BACKGROUND/AIM: This study investigated the effectiveness and safety of liposomal irinotecan plus 5-fluorouracil (5-FU) and leucovorin (LV) as a second-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) and borderline performance status. These patients are often excluded from clinical trials, but may still receive this therapy due to limited alternatives. PATIENTS AND METHODS: A retrospective analysis was conducted on 31 patients with metastatic PDAC and a Karnofsky Performance Status (KPS) of 40-60, who received liposomal irinotecan plus 5-FU/LV at two institutions between 2018 and 2019 in Taiwan. The NAPOLI nomogram was utilized to stratify patients into prognostic groups for survival comparison, with the good prognostic group defined as having total NAPOLI nomogram points ≥ the median value, and the poor prognostic group defined as having total NAPOLI nomogram points < the median value. RESULTS: The median overall survival (OS) for the entire cohort was 4.2 months [95% confidence interval (CI)=3.0-5.3 months]. Patients in the NAPOLI nomogram's good prognostic group had a median OS of 4.9 months (95%CI=3.7-6.1 months), compared to 2.0 months (95%CI=1.5-2.4 months) in the poor prognostic group (p=0.014). Tumor response rates to liposomal irinotecan + 5-FU/LV were partial response in 3%, stable disease in 23%, and progressive disease in 74%, with significant differences in disease progression rates between good (56%) and poor (93%) prognostic groups (p=0.011). The most common grade 3 or 4 chemotherapy-related adverse events included anemia (26%), neutropenia (23%), non-neutropenic infection (19%), mucositis (13%), diarrhea (10%), and fatigue (3%). CONCLUSION: Liposomal irinotecan plus 5-FU/LV regimen is a feasible second-line treatment option for PDAC patients with borderline performance status, with a safety profile consistent with clinical trial findings.