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Clinical Trial
. 2010 Feb;54(2):199-205.
doi: 10.1002/pbc.22225.

Erwinia asparaginase after allergy to E. coli asparaginase in children with acute lymphoblastic leukemia

Lynda M Vrooman  1 , Jeffrey G Supko, Donna S Neuberg, Barbara L Asselin, Uma H Athale, Luis Clavell, Kara M Kelly, Caroline Laverdière, Bruno Michon, Marshall Schorin, Harvey J Cohen, Stephen E Sallan, Lewis B Silverman
Affiliations
Clinical Trial

Erwinia asparaginase after allergy to E. coli asparaginase in children with acute lymphoblastic leukemia

Lynda M Vrooman et al. Pediatr Blood Cancer. 2010 Feb.

Abstract

Background: Escherichia coli asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia (ALL); however, hypersensitivity develops in up to 30% of patients. We assessed the nadir enzyme activity and tolerability of Erwinia asparaginase, an alternative preparation, in E. coli asparaginase-allergic patients.

Patients and methods: Between 2000 and 2002, 215 children with newly diagnosed ALL were enrolled on Dana-Farber Cancer Institute ALL Consortium Protocol 00-01 and were to receive 30 weekly doses of intramuscular E. coli asparaginase. If E. coli asparaginase allergy developed, patients were switched to twice-weekly intramuscular Erwinia asparaginase (25,000 IU/m(2)). Nadir serum asparaginase activity (NSAA) was measured every 3 weeks.

Results: Forty-two patients (20%) developed E. coli asparaginase allergy and switched to Erwinia. Of 38 patients with evaluable samples, 34 (89%) Erwinia-treated patients had at least one therapeutic NSAA (> or =0.1 IU/ml). The median NSAA was 0.247 IU/ml 3 days and 0.077 IU/ml 4 days after an Erwinia dose. Associated toxicities included allergy in 14 (33%) and pancreatitis in 3 patients (7%). At a median follow-up of 5.4 years, event-free survival (+/-standard error) of the 42 patients who switched to Erwinia was 86 +/- 5% compared with 81 +/- 3% for the 170 patients without E. coli asparaginase allergy (P = 0.55).

Conclusions: Twice-weekly Erwinia asparaginase was well tolerated and achieved a therapeutically effective NSAA in most E. coli asparaginase-allergic patients. Development of E. coli allergy and subsequent treatment with twice-weekly Erwinia did not adversely impact event-free survival. Erwinia asparaginase should be considered for E. coli asparaginase-allergic patients.

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Conflict of interest statement

Conflicts of Interest Statement: The following authors have these disclosures: Lewis B. Silverman: Served on advisory board for EUSA Pharma, the manufacturer of Erwinase®. Stephen E. Sallan: Received honoraria and research funding from Enzon INC. Served on advisory board for EUSA Pharma. Jeffrey Supko: Received research funding from EUSA Pharma.

Figures

Figure 1
Figure 1
Consort diagram.
Figure 2
Figure 2
Event-Free Survival. The 5.4-year EFS ± SE for E coli allergic patients switched to Erwinia asparaginase was 86 ± 5% compared with 81 ± 3% for those without asparaginase allergy (p=0.55).
See this image and copyright information in PMC

Comment in

References

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