TY - JOUR
T1 - Allergic Reactions to E. coli Asparaginase are Associated with Decreased Asparaginase Activity in an Indonesian Pediatric Population with ALL
AU - Sari, Nur Melani
AU - Berbudi, Afiat
AU - Susanah, Susi
AU - Reniarti, Lelani
AU - Supriyadi, Eddy
AU - Kaspers, Gertjan J. L.
AU - Buddington, Randal K.
AU - Howard, Scott
AU - Idjradinata, Ponpon
N1 - Funding Information: The authors would like to grateful Ministry of Health by financially support this study through IPTEKES scheme grant 2019. Publisher Copyright: © This work is licensed under a Creative Commons Attribution-Non Commercial 4.0 International License.
PY - 2023/8/1
Y1 - 2023/8/1
N2 - PURPOSE: The asparaginase's (ASP) utility for ALL treatment is limited by neutralizing antibodies, which is problematic in countries whose access limited to alternative preparations. ASP antibody levels and activity was measured during remission induction and associated with allergy manifestations. METHODS: E. coli ASP was dosed at 7500 IU/m2. ASP IgG antibody levels were quantified at the beginning and end of induction. ASP activity was measured 24 hours after 1st and 5th dose (standard-risk) or 7th dose (high-risk patients) administration, and within 24 hours in case of allergic reactions. Allergy was monitored by CTCAE version 3. Parametric and non-parametric was performed for data analysis. RESULTS: ASP antibody and activity levels were available in 41/63 consecutive patients. Allergic manifestations occurred in 13/41, with urticaria being the most frequent. There were no significant differences in subject characteristics based on allergic reactions. The 5th dose was the most frequent time of onset. Antibody levels in allergy group at the end of induction did not differ from those at baseline (p<0.05). Using a 24-hour level of 100 mU/mL as a threshold for adequate ASP activity, 6/13 patients with allergy had adequate levels compared to 26/28 patients without (p<0.05). The ASP activity level at the end of induction phase in both groups did not show a significant decrement. CONCLUSION: The E. coli ASP activity with adequate levels were significantly higher in non-allergy group. Its activity level was not accompanied by increment of IgG in allergic group indicates other factors might affect activity levels in allergy group.
AB - PURPOSE: The asparaginase's (ASP) utility for ALL treatment is limited by neutralizing antibodies, which is problematic in countries whose access limited to alternative preparations. ASP antibody levels and activity was measured during remission induction and associated with allergy manifestations. METHODS: E. coli ASP was dosed at 7500 IU/m2. ASP IgG antibody levels were quantified at the beginning and end of induction. ASP activity was measured 24 hours after 1st and 5th dose (standard-risk) or 7th dose (high-risk patients) administration, and within 24 hours in case of allergic reactions. Allergy was monitored by CTCAE version 3. Parametric and non-parametric was performed for data analysis. RESULTS: ASP antibody and activity levels were available in 41/63 consecutive patients. Allergic manifestations occurred in 13/41, with urticaria being the most frequent. There were no significant differences in subject characteristics based on allergic reactions. The 5th dose was the most frequent time of onset. Antibody levels in allergy group at the end of induction did not differ from those at baseline (p<0.05). Using a 24-hour level of 100 mU/mL as a threshold for adequate ASP activity, 6/13 patients with allergy had adequate levels compared to 26/28 patients without (p<0.05). The ASP activity level at the end of induction phase in both groups did not show a significant decrement. CONCLUSION: The E. coli ASP activity with adequate levels were significantly higher in non-allergy group. Its activity level was not accompanied by increment of IgG in allergic group indicates other factors might affect activity levels in allergy group.
KW - Asparaginase activity
KW - acute lymphoblastic leukemia
KW - allergy
KW - hypersensitivity
KW - neutralization antibody
UR - http://www.scopus.com/inward/record.url?scp=85168973377&partnerID=8YFLogxK
U2 - https://doi.org/10.31557/APJCP.2023.24.8.2773
DO - https://doi.org/10.31557/APJCP.2023.24.8.2773
M3 - Article
C2 - 37642064
SN - 2476-762X
VL - 24
SP - 2773
EP - 2780
JO - Asian Pacific journal of cancer prevention : APJCP
JF - Asian Pacific journal of cancer prevention : APJCP
IS - 8
ER -