PMID- 29940768
OWN - NLM
STAT- MEDLINE
DCOM- 20190701
LR  - 20190701
IS  - 0028-2685 (Print)
IS  - 0028-2685 (Linking)
VI  - 65
IP  - 6
DP  - 2018 Nov 15
TI  - Safety profile of a single pegylated asparaginase (PEG-ASP) dose in remission 
      induction for acute lymphoblastic leukemia (ALL).
PG  - 993-997
LID - 180214N121 [pii]
LID - 10.4149/neo_2018_180214N121 [doi]
AB  - The incorporation of pegylated asparaginase (PEG-ASP) in pediatric and adult 
      acute lymphoblastic leukemia (ALL) protocols remains a worldwide therapeutic 
      approach. However the safety profile remains a challenge, and herein we report 
      the toxicity of an intravenous single dose of 1000 IU/m2 PEG-ASP administered in 
      remission induction for adult ALL patients. Thirty-two patients at median 
      diagnostic age of 32 years (median of 19-65) were included in this analysis. Most 
      patients had B-cell lymphoblastic leukemia (n=26; 78%) and 81% of cases were <55 
      years at study entry. 75% of patients had <30x109/l leukocyte count at diagnosis 
      and median follow-up was 14 months (range 0.8-69). All grade 3/4 adverse events 
      (AEs) after PEG-ASP administration were observed in 24 patients (75%). The most 
      common grade 3/4 AEs were: decreased fibrinogen (58%), increased bilirubin (31%) 
      and increased GGTP (27%). Clinical manifestations related to PEG-ASP were seen in 
      9 patients and included: abdominal pain (n=6), thrombosis (n=2), diarrhea (n=1) 
      and pancreatitis (n=1). The median time from PEG-ASP administration to first 
      toxic symptoms was 7 days (range 1-19), and there were also 4 (13%) early 
      induction deaths. All deaths were observed in >/=50-year-old patients after a 
      median of 5 days following PEG-ASP (range 1-9). Three of these four patients had 
      massive obesity. While all expired patients had grade 4 neutropenia and 
      thrombocytopenia at the time of death, sepsis was not present. Administration of 
      PEG-ASP in induction remission for ALL patients resulted in a significant, but 
      mostly reversible hepatotoxicity. This PEG-ASP treatment should be administered 
      with caution for older, obese patients.
FAU - Helbig, G
AU  - Helbig G
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Armatys, A
AU  - Armatys A
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Boral, K
AU  - Boral K
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Kopinska, A J
AU  - Kopinska AJ
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Wozniczka, K
AU  - Wozniczka K
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Dworaczek, M
AU  - Dworaczek M
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Chromik, K
AU  - Chromik K
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Koclega, A
AU  - Koclega A
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Panz-Klapuch, M
AU  - Panz-Klapuch M
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Wysocka, M
AU  - Wysocka M
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
FAU - Janikowska, A
AU  - Janikowska A
AD  - Department of Hematology and Bone Marrow Transplantation, School of Medicine in 
      Katowice, Medical University of Silesia, Katowice, Poland.
LA  - eng
PT  - Journal Article
DEP - 20180617
PL  - Slovakia
TA  - Neoplasma
JT  - Neoplasma
JID - 0377266
RN  - 0 (Antineoplastic Agents)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 7D96IR0PPM (pegaspargase)
RN  - EC 3.5.1.1 (Asparaginase)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols
MH  - Asparaginase/*therapeutic use
MH  - Humans
MH  - Middle Aged
MH  - Polyethylene Glycols/*therapeutic use
MH  - Precursor Cell Lymphoblastic Leukemia-Lymphoma/*therapy
MH  - Remission Induction
MH  - Young Adult
EDAT- 2018/06/27 06:00
MHDA- 2019/07/02 06:00
CRDT- 2018/06/27 06:00
PHST- 2018/02/14 00:00 [received]
PHST- 2018/05/02 00:00 [accepted]
PHST- 2018/06/27 06:00 [pubmed]
PHST- 2019/07/02 06:00 [medline]
PHST- 2018/06/27 06:00 [entrez]
AID - 180214N121 [pii]
AID - 10.4149/neo_2018_180214N121 [doi]
PST - ppublish
SO  - Neoplasma. 2018 Nov 15;65(6):993-997. doi: 10.4149/neo_2018_180214N121. Epub 2018 
      Jun 17.