Evidence map›Paper›PMID 31099154›Full record

ArticlePediatric blood & cancer2019

Universal premedication and therapeutic drug monitoring for asparaginase-based therapy prevents infusion-associated acute adverse events and drug substitutions.

Stacy L Cooper, David J Young, Caitlin J Bowen, Nicole M Arwood, Sarah G Poggi, Patrick A Brown

Open access · greenAbstract read
In one paragraph

Article in Pediatric blood & cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
8.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Article
  4. Article
  5. Prevention of Subsequent L-Asparaginase Hypersensitivity in Children Through Premedication: A Single-Center Experience.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Efficacy of a Standardized Premedication and Therapeutic Drug Monitoring Protocol for Pegaspargase to Prevent Hypersensitivity Reactions.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022
    Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Premedications for Cancer Therapies: A Primer for the Hematology/Oncology Provider.Journal of the advanced practitioner in oncology · 2021
    Review
  16. Pegaspargase in Practice: Minimizing Toxicity, Maximizing Benefit.Current hematologic malignancy reports · 2021
    Review
  17. Review
  18. Review
  19. Impact of Asparaginase Discontinuation on Outcome in Childhood Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Stacy L CooperDepartment of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland.ORCID 0000-0001-8507-3732
David J YoungDepartment of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland.
Caitlin J BowenInstitute of Human Genetics, Johns Hopkins School of Medicine, Baltimore, Maryland.
Nicole M ArwoodDepartment of Pharmacy, Johns Hopkins Hospital, Baltimore, Maryland.
Sarah G PoggiDepartment of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland.
Patrick A BrownDepartment of Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland.
Johns Hopkins University · USJohns Hopkins Hospital · US

Funding

MEDICAL SCIENTIST TRAINING PROGRAMT32GM007309 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI COX, ANDREA L · 1985 to 2019
$43.2M
LAB RESEARCH TRAINING IN PEDIATRIC ONCOLOGY-HEMATOLOGYT32CA060441 · NCI · JOHNS HOPKINS UNIVERSITY · PI ALAN D FRIEDMAN · 1993 to 2026
$14.9M
NCI NIH HHS T32 CA060441NIGMS NIH HHS T32 GM007309NIH HHS T32CA60441
6 · The paper itself

Abstract

backgroundAsparaginase is a critical component of lymphoblastic leukemia therapy, with intravenous pegaspargase (PEG) as the current standard product. Acute adverse events (aAEs) during PEG infusion are difficult to interpret, representing a mix of drug-inactivating hypersensitivity and noninactivating reactions. Asparaginase Erwinia chrysanthemi (ERW) is approved for PEG hypersensitivity, but is less convenient, more expensive, and yields lower serum asparaginase activity (SAA). We began a policy of universal premedication and SAA testing for PEG, hypothesizing this would reduce aAEs and unnecessary drug substitutions. PROCEDURE: Retrospective chart review of patients receiving asparaginase before and after universal premedication before PEG was conducted, with SAA performed 1 week later. We excluded patients who had nonallergic asparaginase AEs. Primary end point was substitution to ERW. Secondary end points included aAEs, SAA testing, and cost.

resultsWe substituted to ERW in 21 of 122 (17.2%) patients pre-policy, and 5 of 68 (7.4%) post-policy (RR, 0.427; 95% CI, 0.27-0.69, P = 0.028). All completed doses of PEG yielded excellent SAA (mean, 0.90 units/mL), compared with ERW (mean, 0.15 units/mL). PEG inactivation post-policy was seen in 2 of 68 (2.9%), one silent and one with breakthrough aAE. The rate of aAEs pre/post-policy was 17.2% versus 5.9% (RR, 0.342; 95% CI, 0.20-0.58, P = 0.017). Grade 4 aAE rate pre/post-policy was 15% versus 0%. Cost analysis predicts $125 779 drug savings alone per substitution prevented ($12 402/premedicated patient).

conclusionsUniversal premedication reduced substitutions to ERW and aAE rate. SAA testing demonstrated low rates of silent inactivation, and higher SAA for PEG. A substantial savings was achieved. We propose universal premedication for PEG be standard of care.

Indexed as

Administration, IntravenousAdolescentAdultAntineoplastic AgentsAsparaginaseChildChild, PreschoolDrug HypersensitivityDrug MonitoringDrug SubstitutionFemaleFollow-Up StudiesHematologic NeoplasmsHumansInfantMaleAntineoplastic AgentsAsparaginaseasparaginaseleukemiapremedicationtherapeutic drug monitoring

Identifiers

PMID31099154
PMCPMC8294186
OpenAlexW2945356250

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.