• Hung-Yuan Yu, Chun-Yang Lee, Le-Gin Lin, Yee Chao, and Chung-Pin Li.
• Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
• J Chin Med Assoc. 2022 Jan 1; 85 (1): 425042-50.

BackgroundNanoliposomal 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.MethodsWe retrospectively collected the baseline characteristics, treatment courses and dosage, treatment response, overall survival (OS), progression-free survival (PFS), and adverse effects of patients treated with the nal-IRI-based regimen at Taipei Veterans General Hospital.ResultsSixty-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 of 0 to 1, but patients with an Eastern Cooperative Oncology Group performance 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 OS)was 7.9 months (95% confidence interval [CI]: 5.6-10.1 months) and the median PFS was 2.9 months (95% CI: 1.6-4.1 months). Elevated total bilirubin (hazard ratio [HR]: 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%).ConclusionClinically, 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.Copyright © 2021, the Chinese Medical Association.

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