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Pegylated-asparaginase during induction therapy for adult acute lymphoblastic leukaemia: toxicity data from the UKALL14 trial
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Pegylated-asparaginase during induction therapy for adult acute lymphoblastic leukaemia: toxicity data from the UKALL14 trial
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Pegylated-asparaginase during induction therapy for adult acute lymphoblastic leukaemia: toxicity data from the UKALL14 trial
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Journal Article
Pegylated-asparaginase during induction therapy for adult acute lymphoblastic leukaemia: toxicity data from the UKALL14 trial
2017
Overview
Safety and efficacy data on pegylated asparaginase (PEG-ASP) in adult acute lymphoblastic leukaemia (ALL) induction regimens are limited. The UK National Cancer Research Institute UKALL14 trial NCT01085617 prospectively evaluated the tolerability of 1000 IU/m
2
PEG-ASP administered on days 4 and 18 as part of a five-drug induction regimen in adults aged 25–65 years with
de novo
ALL. Median age was 46.5 years. Sixteen of the 90 patients (median age 56 years) suffered treatment-related mortality during initial induction therapy. Eight of the 16 died of sepsis in combination with hepatotoxicity. Age and Philadelphia (Ph) status were independent variables predicting induction death >40 versus ⩽40 years, odds ratio (OR) 18.5 (2.02–169.0),
P
=0.01; Ph− versus Ph+ disease, OR 13.60 (3.52–52.36),
P
<0.001. Of the 74 patients who did not die, 37 (50.0%) experienced at least one grade 3/4 PEG-ASP-related adverse event, most commonly hepatotoxicity (36.5%,
n
=27). A single dose of PEG-ASP achieved trough therapeutic enzyme levels in 42/49 (86%) of the patients tested. Although PEG-ASP delivered prolonged asparaginase activity in adults, it was difficult to administer safely as part of the UKALL14 intensive multiagent regimen to those aged >40 years. It proved extremely toxic in patients with Ph+ ALL, possibly owing to interaction with imatinib.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ 692/499
/ Adult
/ Adults
/ Aged
/ Antineoplastic Agents - administration & dosage
/ Antineoplastic Agents - toxicity
/ Asparaginase - administration & dosage
/ Asparaginase - pharmacokinetics
/ Chemical and Drug Induced Liver Injury - mortality
/ E coli
/ Enzymes
/ Humans
/ Induction Chemotherapy - methods
/ Leukemia
/ Medicine
/ Oncology
/ Original
/ Polyethylene Glycols - administration & dosage
/ Polyethylene Glycols - pharmacokinetics
/ Polyethylene Glycols - toxicity
/ Precursor Cell Lymphoblastic Leukemia-Lymphoma - complications
/ Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy
/ Precursor Cell Lymphoblastic Leukemia-Lymphoma - mortality
/ Safety and security measures
/ Toxicity
