Pegylated-asparaginase during induction therapy for adult acute lymphoblastic leukaemia: toxicity data from the UKALL14 trial

Leukemia. 2017 Jan;31(1):58-64. doi: 10.1038/leu.2016.219. Epub 2016 Aug 2.

Abstract

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/m2 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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / toxicity
  • Asparaginase / administration & dosage
  • Asparaginase / pharmacokinetics
  • Asparaginase / toxicity*
  • Chemical and Drug Induced Liver Injury / mortality
  • Humans
  • Induction Chemotherapy / methods
  • Middle Aged
  • Philadelphia Chromosome
  • 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
  • Sepsis / chemically induced
  • Sepsis / mortality

Substances

  • Antineoplastic Agents
  • Polyethylene Glycols
  • pegaspargase
  • Asparaginase

Associated data

  • ClinicalTrials.gov/NCT01085617
  • ClinicalTrials.gov/NCT01085617