Evidence map›Paper›PMID 38306592›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Continuous PEGasparaginase Dosing Reduces Hypersensitivity Reactions in Pediatric ALL: A Dutch Childhood Oncology Group ALL11 Randomized Trial.

Inge M van der Sluis, Leiah J Brigitha, Marta Fiocco, Hester A de Groot-Kruseman, Marc Bierings, Cor van den Bos, Valerie de Haas, Peter M Hoogerbrugge, Wim J E Tissing, Margreet A Veening and 1 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Guideline
  2. Observational
  3. 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

11 authors at 3 institutions in 1 country.

Inge M van der SluisPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0002-5822-7668
Leiah J BrigithaPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0003-2816-2610
Marta FioccoPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0001-5588-0277
Hester A de Groot-KrusemanPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Marc BieringsPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Cor van den BosPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Valerie de HaasPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0003-0339-6816
Peter M HoogerbruggePrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0003-3012-6109
Wim J E TissingPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Margreet A VeeningPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0001-9503-0795
Rob PietersPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0003-2997-3570
Princess Máxima Center · NLStichting Kinderoncologie Nederland · NLLeiden University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe primary objective of this randomized study was to determine whether a continuous dosing schedule (without the asparaginase-free interval) would result in less hypersensitivity reactions to PEGasparaginase (PEGasp) compared with the standard noncontinuous dosing schedule.

methodsEight hundred eighteen patients (age 1-18 years) with ALL were enrolled in the Dutch Childhood Oncology Group-ALL11 protocol and received PEGasp. Three hundred twelve patients stratified in the medium-risk arm were randomly assigned to receive 14 individualized PEGasp doses once every two weeks in either a noncontinuous or continuous schedule after the first three doses in induction (EudraCT: 2012-000067-25). Hypersensitivity reactions were defined as allergies, allergic-like reactions, and silent inactivation. Secondary end points were other asparaginase-related toxicities, asparaginase activity and antibody levels, and outcome.

resultsDuring induction, 27 of 818 patients (3.3%) experienced hypersensitivity reactions. After random assignment, 4 of 155 (2.6%) in the continuous treatment arm versus 17 of 157 (10.8%) patients in the noncontinuous treatment arm had hypersensitivity reactions (

conclusionA continuous dosing schedule of PEGasp is an effective approach to prevent antibody formation and inactivating hypersensitivity reactions. The continuous PEGasp schedule did not increase toxicity and did not affect the efficacy of the therapy.

Indexed as

AsparaginaseDrug HypersensitivityPolyethylene GlycolsPrecursor Cell Lymphoblastic Leukemia-LymphomaAdolescentAntineoplastic AgentsChildChild, PreschoolDrug Administration ScheduleFemaleHumansInfantMaleNetherlandsAntineoplastic AgentsAsparaginasepegaspargasePolyethylene Glycols

Identifiers

PMID38306592
PMCPMC11095866
OpenAlexW4391466410

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.