Evidence map›Paper›PMID 23741010›Full record

Trial reportBlood2013

Erwinia asparaginase achieves therapeutic activity after pegaspargase allergy: a report from the Children's Oncology Group.

Wanda L Salzer, Barbara Asselin, Jeffrey G Supko, Meenakshi Devidas, Nicole A Kaiser, Paul Plourde, Naomi J Winick, Gregory H Reaman, Elizabeth Raetz, William L Carroll and 1 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Blood, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
9.1field-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

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.

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  13. Haematologica · 2023
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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

11 authors at 10 institutions in 1 country.

Wanda L SalzerUS Army Medical Research and Materiel Command, Fort Detrick, MD 21702-5012, USA. wanda.l.salzer.mil@mail.mil
Barbara Asselin
Jeffrey G Supko
Meenakshi Devidas
Nicole A Kaiser
Paul Plourde
Naomi J Winick
Gregory H Reaman
Elizabeth Raetz
William L Carroll
Stephen P Hunger
Boston Children's Hospital · USChildren's Hospital Colorado · USChildren's National · USHarvard University · USNew York University · USNYU Langone Health · USThe University of Texas Southwestern Medical Center · USUnited States Army Medical Research and Development Command · USUniversity of Florida · USUniversity of Rochester Medical Center · US

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
CHILDRENS CANCER STUDY GROUP CHAIRMAN'S GRANTU10CA013539 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI REAMAN, GREGORY H · 1985 to 2002
$43.1M
NCI NIH HHS CA13539NCI NIH HHS CA98543NCI NIH HHS U10 CA098543
6 · The paper itself

Abstract

AALL07P2 evaluated whether substitution of Erwinia asparaginase 25000 IU/m(2) for 6 doses given intramuscularly Monday/Wednesday/Friday (M/W/F) to children and young adults with acute lymphoblastic leukemia and clinical allergy to pegaspargase would provide a 48-hour nadir serum asparaginase activity (NSAA) ≥ 0.10 IU/mL. AALL07P2 enrolled 55 eligible/evaluable patients. NSAA ≥ 0.1 IU/mL was achieved in 38 of 41 patients (92.7%) with acceptable samples 48 hours and in 38 of 43 patients (88.4%) 72 hours after dosing during course 1. Among samples obtained during all courses, 95.8% (252 of 263) of 48-hour samples and 84.5% (125 of 148) of 72-hour samples had NSAA ≥ 0.10-IU/mL. Pharmacokinetic parameters were estimated by fitting the serum asparaginase activity-time course for all 6 doses given during course 1 to a 1-compartment open model with first order absorption. Erwinia asparaginase administered with this schedule achieved therapeutic NSAA at both 48 and 72 hours and was well tolerated with no reports of hemorrhage, thrombosis, or death, and few cases of grade 2 to 3 allergic reaction (n = 6), grade 1 to 3 hyperglycemia (n = 6), or grade 1 pancreatitis (n = 1). Following allergy to pegaspargase, Erwinia asparaginase 25000 IU/m(2) × 6 intramuscularly M/W/F can be substituted for a single dose of pegaspargase.

Indexed as

Drug SubstitutionAdolescentAntineoplastic AgentsAsparaginaseChildChild, PreschoolDrug Administration ScheduleDrug HypersensitivityErwiniaFemaleHumansInjections, IntramuscularMaleMedical OncologyPolyethylene GlycolsPrecursor Cell Lymphoblastic Leukemia-LymphomaAntineoplastic AgentsAsparaginasepegaspargasePolyethylene Glycols

Identifiers

PMID23741010
PMCPMC3724190
OpenAlexW1966763079

What OpenQuestion holds

Textmetadata
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.