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Pancreas ; 44(7): 1141-7, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26355551

ABSTRACT

OBJECTIVES: Asparaginase encapsulated in erythrocytes (ERY-ASP) is a potentially effective drug in patients with pancreatic adenocarcinoma (PAC) with null/low asparagine synthetase (ASNS) expression. Our aims were to assess ASNS expression in PAC from a large cohort and its prognostic and/or predictive value and to conduct a phase I trial with ERY-ASP in patients with metastatic PAC. METHODS: Asparagine synthetase expression was evaluated using immunohistochemistry in resected PAC (471 patients) and in pairs of primary tumor and metastases (55 patients). Twelve patients were included in the phase I trial and received a single administration of ERY-ASP (25-150 IU/kg). RESULTS: Null/low ASNS expression was found in 79.4% of the resected PAC with a high concordance between primary tumor and metastases. Asparagine synthetase expression was significantly correlated with sex and CXCR4 expression. In the phase I trial, ERY-ASP was well tolerated by patients with metastatic PAC. No patient had DLTs, and 6 patients had at least 1 ERY-ASP causally related adverse event out of the 12 adverse events reported. CONCLUSIONS: Given the high rate of PAC with null/low ASNS expression and the good tolerability profile of ERY-ASP, ERY-ASP should be evaluated in further clinical studies in metastatic PAC.


Subject(s)
Adenocarcinoma/drug therapy , Asparaginase/therapeutic use , Erythrocytes/enzymology , Pancreatic Neoplasms/drug therapy , Adenocarcinoma/enzymology , Administration, Intravenous , Adult , Aged , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/pharmacokinetics , Antineoplastic Agents/therapeutic use , Asparaginase/adverse effects , Asparaginase/biosynthesis , Chemical and Drug Induced Liver Injury/etiology , Cohort Studies , Drug Hypersensitivity/etiology , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/methods , Female , Humans , Immunohistochemistry , Kaplan-Meier Estimate , Male , Middle Aged , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/statistics & numerical data , Pancreatic Neoplasms/enzymology , Prognosis , Proportional Hazards Models , Pancreatic Neoplasms
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