PMID- 37501538
OWN - NLM
STAT- Publisher
LR  - 20230728
IS  - 1477-092X (Electronic)
IS  - 1078-1552 (Linking)
DP  - 2023 Jul 27
TI  - Adverse events associated with Pegaspargase biosimilar in pediatric patients with 
      acute lymphoblastic leukemia: A prospective single-center study.
PG  - 10781552231190827
LID - 10.1177/10781552231190827 [doi]
AB  - BACKGROUND: While Pegaspargase is an essential component of the treatment of 
      acute lymphoid leukemia (ALL) in children, it causes adverse events (AEs) that 
      sometimes make full use impossible. OBJECTIVE: The objective was to investigate 
      the safety of Pegaspargase biosimilar in pediatric ALL patients undergoing 
      treatment according to ICiCLe ALL-14 protocol. METHOD AND MATERIALS: A 
      prospective study was carried out in a university teaching hospital located in 
      the state of Maharashtra, India. Data on clinical factors and adverse reaction 
      characteristics were gathered from hospital medical records. Suspected AEs were 
      classified according to causality and severity. RESULTS: During the study period, 
      72 children had 52 suspicions of AEs during treatment with biosimilar 
      Pegaspargase. The odds ratio of 1.11 (95%CI, 0.41-2.98) suggested that males and 
      females were both equally likely to experience adverse drug events, despite the 
      fact that the frequency of suspected AEs was higher in boys (66%) than in girls 
      (33%). None of the patients experienced allergic reactions. The high-risk 
      category had the highest number of suspected AEs (56%), followed by intermediate 
      risk (20%) and standard risk (20%). These patients showed a high frequency of 
      suspected AEs during the induction phase (43%) followed by the consolidation 
      phase (26%). Sixty percent of the reactions were classified as grade 1 or 2. ALL 
      cell type (p = 0.02), risk category (p = 0.04) and length of hospitalization 
      (p = 0.003) were significantly correlated with suspected AEs. CONCLUSION: 
      Bio-similar Pegaspargase in combination with chemotherapy was safe and tolerable 
      in the pediatric ALL patients treated according to ICiCLe ALL-14 protocol. 
      Suspected AEs ranged from mild to moderate and hepatic failure and hyperglycemia 
      being severe.
FAU - Panda, Bijoy Kumar
AU  - Panda BK
AUID- ORCID: 0000-0001-8807-196X
AD  - Department of Pharmacy Practice, Krishna Institute of Pharmacy, Krishna Vishwa 
      Vidyapeeth (Deemed to be University), Karad, Maharashtra, India.
FAU - Gaikwad, Mahima
AU  - Gaikwad M
AD  - Department of Pharmacy Practice, Poona College of Pharmacy, Bharati Vidyapeeth 
      (Deemed to be University), Pune, Maharashtra, India.
FAU - Bafna, Vibha
AU  - Bafna V
AD  - Department of Paediatric Oncology and Hematology, Bharati Vidyapeeth (Deemed to 
      be University) Medical College and Hospital Research Centre, Pune, Maharashtra, 
      India.
FAU - Vaidya, Neela
AU  - Vaidya N
AD  - Department of Biochemistry, Bharati Vidyapeeth (Deemed to be University) Medical 
      College and Hospital Research Centre, Pune, Maharashtra, India.
FAU - Aundhe, Vishal
AU  - Aundhe V
AD  - Department of Pharmacy Practice, Poona College of Pharmacy, Bharati Vidyapeeth 
      (Deemed to be University), Pune, Maharashtra, India.
FAU - Mhatre, Angha
AU  - Mhatre A
AUID- ORCID: 0009-0008-2107-6975
AD  - Department of Pharmacy Practice, Poona College of Pharmacy, Bharati Vidyapeeth 
      (Deemed to be University), Pune, Maharashtra, India.
LA  - eng
PT  - Journal Article
DEP - 20230727
PL  - England
TA  - J Oncol Pharm Pract
JT  - Journal of oncology pharmacy practice : official publication of the International 
      Society of Oncology Pharmacy Practitioners
JID - 9511372
SB  - IM
OTO - NOTNLM
OT  - Acute lymphoblastic leukemia
OT  - Pegaspargase, pediatric
OT  - adverse event
EDAT- 2023/07/28 06:43
MHDA- 2023/07/28 06:43
CRDT- 2023/07/28 03:13
PHST- 2023/07/28 06:43 [medline]
PHST- 2023/07/28 06:43 [pubmed]
PHST- 2023/07/28 03:13 [entrez]
AID - 10.1177/10781552231190827 [doi]
PST - aheadofprint
SO  - J Oncol Pharm Pract. 2023 Jul 27:10781552231190827. doi: 
      10.1177/10781552231190827.