Efficacy and Toxicity of Pegaspargase and Calaspargase Pegol in Childhood Acute Lymphoblastic Leukemia: Results of DFCI 11-001.
Adolescent
Adult
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Asparaginase
/ administration & dosage
Child
Child, Preschool
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Female
Follow-Up Studies
Humans
Infant
Male
Polyethylene Glycols
/ administration & dosage
Precursor Cell Lymphoblastic Leukemia-Lymphoma
/ drug therapy
Prognosis
Survival Rate
United States
/ epidemiology
Young Adult
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333
Informations de publication
Date de publication:
01 11 2021
01 11 2021
Historique:
pubmed:
7
7
2021
medline:
22
12
2021
entrez:
6
7
2021
Statut:
ppublish
Résumé
Dana-Farber Cancer Institute Acute Lymphoblastic Leukemia (ALL) Consortium Protocol 11-001 assessed efficacy and toxicity of calaspargase pegol (calaspargase), a novel pegylated asparaginase formulation with longer half-life, compared with the standard formulation pegaspargase. Patients age 1 to ≤ 21 years with newly diagnosed ALL or lymphoblastic lymphoma were randomly assigned to intravenous pegaspargase or calaspargase, 2,500 IU/m Between 2012 and 2015, 239 eligible patients enrolled (230 ALL, nine lymphoblastic lymphoma); 120 were assigned to pegaspargase and 119 to calaspargase. After the induction dose, SAA was ≥ 0.1 IU/mL in ≥ 95% of patients on both arms 18 days after dosing. At day 25, more patients had SAA ≥ 0.1 IU/mL with calaspargase (88% Every 3-week calaspargase had similar nadir SAA, toxicity, and survival outcomes compared with every 2-week pegaspargase. The high nadir SAA observed for both preparations suggest dosing strategies can be further optimized.
Identifiants
pubmed: 34228505
doi: 10.1200/JCO.20.03692
doi:
Substances chimiques
Polyethylene Glycols
3WJQ0SDW1A
pegaspargase
7D96IR0PPM
Asparaginase
EC 3.5.1.1
calaspargase pegol
EC 3.5.1.1
Banques de données
ClinicalTrials.gov
['NCT01574274']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM