A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer

Abstract

Although nanoliposomal irinotecan combined with 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) has been used to treat first-line resistant unresectable pancreatic cancer, the efficacy and safety data among the elderly remain limited. We retrospectively analyzed clinical outcomes among elderly patients. Patients treated with nal-IRI+5-FU/LV were assigned to the elderly (≥75 years) and non-elderly (<75 years) groups. Herein, 85 patients received nal-IRI+5-FU/LV, with 32 assigned to the elderly group. Patient characteristics in the elderly and non-elderly groups were as follows: age: 78.5 (75–88)/71 (48–74), male: 17/32 (53%/60%), performance status (ECOG) 0:9/20 (28%/38%), nal-IRI+5-FU/LV in second line: 23/24 (72%/45%), respectively. A significantly high number of elderly patients exhibited aggravated kidney and hepatic functions. Median overall survival (OS) and progression-free survival (PFS) in the elderly group vs. non-elderly group were 9.4 months vs. 9.9 months (hazard ratio (HR) 1.51, 95% confidence interval (CI) 0.85–2.67, p = 0.16) and 3.4 months vs. 3.7 months (HR 1.41, 95% CI 0.86–2.32, p = 0.17). Both groups exhibited a similar incidence of efficacy and adverse events. There were no significant differences in OS and PFS between groups. We analyzed the C-reactive protein/albumin ratio (CAR) and neutrophil/lymphocyte ratio (NLR) as indicators that could determine eligibility for nal-IRI+5-FU/LV. The median CAR and NLR scores in the ineligible group were 1.17 and 4.23 (p < 0.001 and p = 0.018, respectively). Elderly patients with worse CAR and NLR score could be deemed ineligible for nal-IRI+5-FU/LV.

Risk Factors for Adverse Events of Nanoliposomal Irinotecan Plus 5-Fluorouracil and L-leucovorin

“…There are many reports on predictors of treatment-response by nal-IRI-based therapy. In particular, CAR, NLR, GPS, total bilirubin, carcinomatosis, and previous treatment with irinotecan have been significantly associated with overall survival (3)(4)(5)(6)(7)(8). However, no study has reported the risk factors for the adverse events during nal-IRI/FL treatment based on the analysis of factors other than the UGT1A1 polymorphism in clinical settings.…”

“…Based on this trial result, the regulatory agency in Japan has approved the nal-IRI plus 5-FU and L-leucovorin (nal-IRI/FL) combination therapy. Particularly interesting studies focused on predictors of treatment-response by nal-IRI-based therapy in patients with pancreatic cancer have indicated that C-reactive protein/albumin ratio (CAR), neutrophil/lymphocyte ratio (NLR), Glasgow prognostic score (GPS), total bilirubin, carcinomatosis, and previous irinotecan treatment are significantly associated with overall survival (3)(4)(5)(6)(7)(8).…”