PEG-asparaginase allergy in children with acute lymphoblastic leukemia in the NOPHO ALL2008 protocol
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
PEG-asparaginase allergy in children with acute lymphoblastic leukemia in the NOPHO ALL2008 protocol. / Henriksen, Louise Tram; Harila-Saari, Arja; Ruud, Ellen; Abrahamsson, Jonas; Pruunsild, Kaie; Vaitkeviciene, Goda; Jónsson, Ólafur Gísli; Schmiegelow, K.; Heyman, Mats; Schrøder, Henrik; Albertsen, Birgitte Klug; Nordic Society of Paediatric Haematology and Oncology (NOPHO) group.
I: Pediatric Blood & Cancer, Bind 62, Nr. 3, 03.2015, s. 427-33.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - PEG-asparaginase allergy in children with acute lymphoblastic leukemia in the NOPHO ALL2008 protocol
AU - Henriksen, Louise Tram
AU - Harila-Saari, Arja
AU - Ruud, Ellen
AU - Abrahamsson, Jonas
AU - Pruunsild, Kaie
AU - Vaitkeviciene, Goda
AU - Jónsson, Ólafur Gísli
AU - Schmiegelow, K.
AU - Heyman, Mats
AU - Schrøder, Henrik
AU - Albertsen, Birgitte Klug
AU - Nordic Society of Paediatric Haematology and Oncology (NOPHO) group
N1 - © 2014 Wiley Periodicals, Inc.
PY - 2015/3
Y1 - 2015/3
N2 - BACKGROUND: L-Asparaginase is an effective drug in the treatment of childhood acute lymphoblastic leukemia (ALL). The use of L-asparaginase may be limited by serious adverse events of which allergy is the most frequent. The objective of this study was to describe the clinical aspects of PEG-asparaginase allergy in children treated according to the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL2008 protocol.PROCEDURE: Children (1-17 years) enrolled in the NOPHO ALL2008 protocol between July 2008 and August 2011, who developed PEG-asparaginase allergy were identified through the NOPHO ALL2008 toxicity registry. In the NOPHO ALL2008 protocol, patients are randomized to 8 or 15 doses of intramuscular PEG-asparaginase (Oncaspar®) 1,000 IU/m(2) /dose administered at 2 or 6 weeks intervals during a total period of 30 weeks. (Clinical trials.gov no: NCT00819351).RESULTS: Of 615 evaluable patients, 79 patients developed clinical PEG-asparaginase allergy (cumulative risk; 13.2%) and discontinued PEG-asparaginase therapy for that reason. PEG-asparaginase allergy occurred after a median of two doses (75% range 2-4, max 14). In 58% of PEG-asparaginase hypersensitive patients, the clinical allergic reactions appeared within 2 hr after PEG-asparaginase administration and ranged from mild symptoms to systemic anaphylaxis. Nine patients experienced an anaphylactic reaction within 1 hr and 50 min from asparaginase administration; none were fatal. Four of 68 patients (6%) who subsequently received Erwinase therapy also reacted allergic to Erwinase.CONCLUSION: Clinical allergy to PEG-asparaginase occurred early in treatment, was in general moderate in severity, and mostly developed within 2 hr after PEG-asparaginase administration. The risk of subsequent Erwinase allergic reactions was low.
AB - BACKGROUND: L-Asparaginase is an effective drug in the treatment of childhood acute lymphoblastic leukemia (ALL). The use of L-asparaginase may be limited by serious adverse events of which allergy is the most frequent. The objective of this study was to describe the clinical aspects of PEG-asparaginase allergy in children treated according to the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL2008 protocol.PROCEDURE: Children (1-17 years) enrolled in the NOPHO ALL2008 protocol between July 2008 and August 2011, who developed PEG-asparaginase allergy were identified through the NOPHO ALL2008 toxicity registry. In the NOPHO ALL2008 protocol, patients are randomized to 8 or 15 doses of intramuscular PEG-asparaginase (Oncaspar®) 1,000 IU/m(2) /dose administered at 2 or 6 weeks intervals during a total period of 30 weeks. (Clinical trials.gov no: NCT00819351).RESULTS: Of 615 evaluable patients, 79 patients developed clinical PEG-asparaginase allergy (cumulative risk; 13.2%) and discontinued PEG-asparaginase therapy for that reason. PEG-asparaginase allergy occurred after a median of two doses (75% range 2-4, max 14). In 58% of PEG-asparaginase hypersensitive patients, the clinical allergic reactions appeared within 2 hr after PEG-asparaginase administration and ranged from mild symptoms to systemic anaphylaxis. Nine patients experienced an anaphylactic reaction within 1 hr and 50 min from asparaginase administration; none were fatal. Four of 68 patients (6%) who subsequently received Erwinase therapy also reacted allergic to Erwinase.CONCLUSION: Clinical allergy to PEG-asparaginase occurred early in treatment, was in general moderate in severity, and mostly developed within 2 hr after PEG-asparaginase administration. The risk of subsequent Erwinase allergic reactions was low.
KW - Adolescent
KW - Adult
KW - Anaphylaxis
KW - Antineoplastic Agents
KW - Asparaginase
KW - Child
KW - Child, Preschool
KW - Drug Hypersensitivity
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Infant
KW - Male
KW - Polyethylene Glycols
KW - Precursor Cell Lymphoblastic Leukemia-Lymphoma
KW - Risk Factors
U2 - 10.1002/pbc.25319
DO - 10.1002/pbc.25319
M3 - Journal article
C2 - 25418987
VL - 62
SP - 427
EP - 433
JO - Pediatric Blood & Cancer
JF - Pediatric Blood & Cancer
SN - 1545-5009
IS - 3
ER -
ID: 162455360