Use of Paclitaxel Associated to Lipid Core Nanoparticles (LDE) in the Second or Third Line Treatment of Advanced Pancreatic Adenocarcinoma

Abstract

Background: Previously, we showed that paclitaxel carried in non-protein Lipid Core Nanoparticles (LDE) resembling the lipid structure of LDL has remarkably reduced toxicity in patients with advanced solid cancers, as used in 3 rd line chemotherapy or further. The aim was to test LDE-paclitaxel treatment in progressive, advanced pancreatic adenocarcinoma as second or third line of therapy.Methods: This was a prospective, single-arm study enrolling patients that had been previously submitted to at least one standard chemotherapy scheme. LDE-paclitaxel was administered at weekly infusion of 85mg/m² B.W. dose, with two-week intervals between the 7 th and the next dose.Results: Nine consecutive patients were studied. Maximum 5 cycles were performed before disease progression or death. In none of the patients treatment was discontinued or dose was reduced for drug toxicity. LDE-paclitaxel presented only CTCAE grade 1 and 2 toxicities, anemia and neuropathy being most frequent, with no grade 3 or 4 toxicities. Patient survival after initiation of LDE-paclitaxel use was 4.7 months with no decline in the assessed quality of life indices while they were being treated. Total overall survival was 20.14 months. Conclusion:LDE-paclitaxel treatment in patients with advanced pancreatic adenocarcinoma at 2 nd or 3 rd line setting showed remarkably low toxicity and tolerability and the survival data seem satisfactory in view of the previous studies from the literature. Thus, the results pave the way for future clinical trials on LDE-paclitaxel and encourage testing this formulation in 1 st line therapy schemes in pancreatic adenocarcinoma.