Nanoliposomal irinotecan with 5-fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy: a real-world experience.

Background Nanoliposomal irinotecan (nal-IRI), accompanied by 5-fluorouracil (5-FU) and leucovorin (LV), is an effective and safe therapy for patients in whom metastatic pancreatic ductal adenocarcinoma has progressed after gemcitabine-based chemotherapy. Our aim was to evaluate the effectiveness and safety of a nal-IRI + 5-FU/LV regimen for patients with metastatic pancreatic cancer and gemcitabine-based treatment failure in the real world. Methods We retrospectively collected the baseline characteristics, treatment courses and dosage, treatment response, overall survival, progression-free survival, and adverse effects of patients treated with the nal-IRI-based regimen at Taipei Veterans General Hospital. Results Sixty-seven patients who received the nal-IRI + 5-FU/LV regimen from August 2018 to June 2019 were identified. Their median age was 65 years and 52% were male. Most patients had an Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 1, but patients with an ECOG status of 2 to 4 before initiation of the nal-IRI regimen were also enrolled (31%). The median dose intensity was 40.4 mg/m2 and the median treatment duration was 8.3 weeks (range: 5 days - 75.7 weeks). Objective response and disease control rates were 10.4% and 38.8%, respectively. The median overall survival (OS) was 7.9 months (95% confidence interval (CI): 5.6 - 10.1 months) and the median progression-free survival (PFS) was 2.9 months (95% CI: 1.6 - 4.1 months). Elevated total bilirubin (hazard ratio: 4.31, 95% CI: 1.21 -15.30, p = 0.024), carcinomatosis (HR: 3.75, 95% CI: 1.46 - 9.66, p = 0.006), and previous treatment with irinotecan (HR: 4.86, 95% CI: 1.67 - 14.10, p = 0.004) were associated with a worse OS. Previous treatment with irinotecan (HR: 3.03, 95% CI: 1.22 - 7.49, p = 0.02) was associated with a worse PFS. The most common all-grade adverse effects were anemia (73.9%), nausea (66.2%), and fatigue (61.5%). The most common grade 3 - 4 adverse effects were neutropenia (21.5%), anemia (18.5%), and diarrhea (15.4%). Conclusion Clinically, nal-IRI + 5-FU/LV is effective and tolerable at reduced doses in patients with metastatic pancreatic adenocarcinoma that has progressed after gemcitabine-based therapy.