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Blood, 15 April 2002, Vol. 99, No. 8, pp. 2734-2739
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Comparison of Escherichia coli-asparaginase with
Erwinia-asparaginase in the treatment of childhood lymphoid
malignancies: results of a randomized European Organisation for
Research and Treatment of Cancer Children's Leukemia Group phase
3 trial
Michel Duval,
Stefan Suciu,
Alina Ferster,
Xavier Rialland,
Brigitte Nelken,
Patrick Lutz,
Yves Benoit,
Alain Robert,
Anne-Marie Manel,
Etienne Vilmer,
Jacques Otten, and
Noël Philippe for the European Organisation
for Research and Treatment of Cancer Children's Leukemia
Group
From service d'Hémato-Immunologie, Hôpital
Robert-Debré, Paris, France; European Organisation for Research
and Treatment of Cancer, Brussels, Belgium; Centre Hospitalier
Universitaire, Reine Fabiola, Brussels, Belgium; Centre Hospitalier
Universitaire, Angers, France; Centre Hospitalier Universitaire, Lille,
France; Centre Hospitalier Universitaire, Strasbourg, France; Gent
University Hospital, Gent, Belgium; Centre Hospitalier Universitaire,
Toulouse, France; Centre Hospitalier Universitaire, Lyon, France; and
Akademisch Ziekenhuis, Vrije Universiteit Brussel, Brussels, Belgium.
Asparaginase is an enzyme used in the treatment of acute
lymphoblastic leukemia and lymphoblastic lymphoma in children. It has
minimal bone marrow toxicity. Its major side effects are anaphylaxis, pancreatitis, diabetes, coagulation abnormalities, and thrombosis, especially intracranial. It is derived from 2 different
sources: Escherichia coli and Erwinia
chrysanthemi. Nonrandomized clinical studies have suggested a
similar efficacy of these 2 types of asparaginases and a lower toxicity
for Erwinia-asparaginase. The European Organisation for
Research and Treatment of Cancer-Children's Leukemia Group
(EORTC-CLG) 58881 trial randomized 700 children with acute
lymphoblastic leukemia or lymphoblastic lymphoma to either
E coli- or Erwinia-asparaginase at the same
dosage of 10 000 IU/m2 twice weekly to compare toxicity
and efficacy. Coagulation abnormalities were more frequent in the
E coli-asparaginase than in the
Erwinia-asparaginase arm of the study (30.2% versus
11.9%, P < .0001). The incidence of other toxicity was
not significantly different. In the Erwinia-asparaginase arm, more patients failed to achieve complete remission (4.9% versus
2.0%; P = .038) and the relapse rate was higher, leading to shorter event-free survival (hazard ratio,1.59; 95% CI,
1.23-2.06; P = .0004). The estimate of event-free
survival rate (SE) at 6 years was 59.8% (2.6%) versus 73.4%
(2.4%). Overall survival rate at 6 years was also lower in the
Erwinia-asparaginase arm at 75.1% (2.3%) versus 83.9%
(2.0%), P = .002. With the dose scheduling used in this
protocol, E coli-asparaginase induced more coagulation abnormalities but was superior to
Erwinia-asparaginase for the treatment of childhood
lymphoid malignancies.
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