Relationship between initial dose, dose intensity, and survival in unresectable pancreatic cancer treated with nanoliposomal irinotecan, fluorouracil, and folinic acid

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Abstract While nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard second-line regimen for unresectable pancreatic cancer (uPC) after gemcitabine-based therapy, the effects of initial dosing and relative dose intensity (RDI) in routine practice are unclear. We retrospectively analyzed 161 patients (median age 67 years; 55% male) with uPC treated with NFF at 20 Japanese institutions (June 2020–May 2021), comparing standard vs. reduced starting dose and RDI ≥80% vs. <80%. Overall survival (OS) was 8.1 vs. 8.8 months for standard vs. reduced dose ( p = 0.47; hazard ratio [HR], 1.15) and 7.5 vs. 9.2 months for RDI ≥80% vs. <80% ( p = 0.39; HR, 0.85). Progression-free survival (PFS) was 3.4 vs. 3.2 months ( p = 0.43) and 2.8 vs. 4.4 months ( p = 0.13), respectively, with similar response and disease control rates. Anemia, thrombocytopenia, and vomiting occurred more frequently in patients administered the standard starting dose, whereas severe non-hematologic adverse events were more frequently observed for RDI <80%. Reduced starting dose and RDI <80% were not associated with inferior survival, suggesting that individualized dose modification may be feasible. Future prospective studies are warranted to refine NFF dosing strategies.

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