Abstract
Liposomal irinotecan plus 5-fluorouracil/leucovorin (nal-IRI + 5-FU/LV) has shown to provide survival benefits for patients with gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (PDAC) in NAPOLI-1 trial, in which Asian patients experienced more hematological toxicity and subsequent dose modification. A retrospective chart review to investigate the administration pattern, therapeutic efficacy and safety profile of nal-IRI + 5-FU/LV in 44 consecutive patients with gemcitabine-refractory advanced PDAC treated between December 2016 and December 2018 in National Cheng Kung University Hospital, Taiwan. Most of them had metastatic diseases (88.6%), one-line of prior treatment (72.7%), ECOG PS 0-1 (72.7%) and starting dose of nal-IRI at 60 mg/m2 (≈52 mg/m2 irinotecan free-base) in 65.9%. The overall response rate was 9.1%. The median OS was 6.6 months for the entire cohort, and 7.8 and 2.7 months for patients of ECOG PS 0-1 and>2, respectively. The median OS of ECOG PS 0-1 patients with nal-IRI starting doses at 80 mg/m2 (≈70 mg/m2 irinotecan free-base, n = 13) and 60 mg/m2 (n = 19) were 7.5 and 8.4 months, respectively. Thirty-four percent of patients experienced manageable grade 3-4 hematological toxicity. Our results confirm the clinical benefit of nal-IRI + 5-FU/LV for patients of gemcitabine-refractory advanced PDAC with good performance status in a real-world setting.
Highlights
Majority of patients with pancreatic ductal adenocarcinoma (PDAC), the most common histological type of pancreatic cancer, presented with either unresectable locally advanced or metastatic diseases upon diagnosis
While biweekly triplet chemotherapy consisting of gemcitabine, oxaliplatin plus either infusion 5-FU/LV or oral S-1/LV that have been developed through a series of multicenter trials under the platform of Taiwan Cooperative Oncology Group (TCOG) are the favorable regimens in our institutional clinical practice[14,15]
Nal-IRI is a new formulation of irinotecan encapsulated in pegylated liposomes which prevents the premature metabolism of irinotecan in the liver and can passively diffuse through leaky tumor vasculature, resulting in favorable circulation and intra-tumor pharmacokinetics of SN-38, the active metabolite of irinotecan, as compared to conventional irinotecan[18,19]
Summary
Majority of patients with pancreatic ductal adenocarcinoma (PDAC), the most common histological type of pancreatic cancer, presented with either unresectable locally advanced or metastatic diseases upon diagnosis. The progress in systemic chemotherapy for advanced PDAC has been limited until the emergence of FOLFIRINOX (5-FU/leucovorin + irinotecan + oxaliplatin) and the gemcitabine plus nab-paclitaxel regimens in early 2010s Both regimens provided significant survival benefits over gemcitabine monotherapy, with a median OS of 11.1 versus 6.8 months (hazard ratio [HR] = 0.57, p < 0.001) and 8.5 versus 6.7 (95% CI: 6.0–7.2) months, HR = 0.72 (P < 0.001), respectively[5,6], and have currently been recognized as global standard first-line treatments for patients of advanced PDAC with good general condition[7,8,9,10,11]. We report the experience from National Cheng Kung University Hospital (NCKUH), a high-volume medical center for pancreatic cancer management in southern Taiwan[23]
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