Liposomal irinotecan plus fluorouracil/leucovorin in older patients with advanced pancreatic cancer: a single-center retrospective study

Abstract Background: The global phase 3 NAPOLI -1 trial of patients with pancreatic ductal adenocarcinoma demonstrated an overall survival (OS) benefit from using liposomal irinotecan and 5-fluorouracil/leucovorin (nal-IRI+5-FU/LV) after treatment with gemcitabine when compared to 5-FU/LV alone. However, the efficacy and safety of this regimen in older patients are not well studied. Methods: This single-center retrospective study compared results of nal-IRI+5FU/LV between older and younger patients. Results: Of 115 patients, 54 (47.0%) and 24 (20.9%) were aged ≥70 and ≥75 years, respectively. The median OS and progression-free survival of the entire cohort were 8.5 and 3.6 months, respectively. There were no significant differences in OS and PFS hazard ratios using cutoffs of 70 years (P = 0.90 and 0.99, respectively) and 75 years (P = 0.90 and 0.76, respectively). There were also no significant differences in the incidence of treatment-related adverse events between patients aged ≥70 and <70 years, or those aged ≥75 and <75 years. Other than hematological toxicity, no treatment-related adverse events higher than Grade 4 were observed in either age group. Conclusion: The efficacy and safety of nal-IRI+5-FU/LV for patients with pancreatic ductal adenocarcinoma are not significantly different for patients aged 70 years and older compared to younger patients.