Introduction: Nanoliposomal irinotecan (nal-IRI) + 5- fluorouracil (FU)/leucovorin (LV) is the new standard second-line therapy for advanced pancreatic cancer (PC). Tegafur, gimeracil, and oteracil potassium (S-1) have been used in advanced PC after gemcitabine (GEM) plus nab-paclitaxel treatment, but the clinical difference between nal-IRI+5-FU/LV and S-1 remains unclear.
Methods: We retrospectively compared the efficacy and safety of nal-IRI+5-FU/LV and S-1 in patients with advanced PC refractory to GEM plus nab-paclitaxel. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.
Results: We analyzed patients with advanced PC who were refractory to GEM plus nab-paclitaxel from May 2015 to January 2022 at our hospital. Twelve patients treated with nal-IRI+5-FU/LV and 51 patients treated with S-1 were included in this study. Comparing the nal-IRI+5-FU/LV and S-1 groups, the median PFS was 2.95 months vs. 2.10 months (p=0.658), respectively, and the median OS was 8.51 months vs. 5.83 months (p=0.763), respectively. The ORR and DCR were 8.3% and 2.0% (p=0.347) and 58.3% and 49.0% (p=0.750) for the nal-IRI+5-FU/LV and S-1 groups, respectively. There were no significant differences in adverse events between the two groups. In a subgroup analysis, patients under 65 years of age treated with S-1 had a significantly better median OS (HR, 3.46; 95% CI: 1.02-11.71, p=0.046).
Conclusion: Nal-IRI+5-FU/LV and S-1 were equally effective and safe as second-line therapy for PC. However, the results suggest that S1 is an option for younger patients, especially those under 65 years.
S. Karger AG, Basel.