Evidence map›Paper›PMID 31360884›Full record

ArticleJNCI cancer spectrum2018

Validation of Minimal Residual Disease as Surrogate Endpoint for Event-Free Survival in Childhood Acute Lymphoblastic Leukemia.

Stefania Galimberti, Meenakshi Devidas, Ausiliatrice Lucenti, Giovanni Cazzaniga, Anja Möricke, Claus R Bartram, Georg Mann, William Carroll, Naomi Winick, Michael Borowitz and 9 more

Abstract read
In one paragraph

Article in JNCI cancer spectrum, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. 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

19 authors.

Stefania GalimbertiCenter of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.
Meenakshi DevidasDepartment of Biostatistics, College of Medicine, Public Health and Health Professions, University of Florida, Gainesville, FL.
Ausiliatrice LucentiCenter of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.
Giovanni CazzanigaFondazione Tettamanti, Monza, Italy.
Anja MörickeDepartment of Pediatrics, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Claus R BartramInstitute of Human Genetics, University of Heidelberg, Heidelberg, Germany.
Georg MannSt. Anna Kinderspital, Wien, Austria.
William CarrollDepartment of Pediatrics, New York University Langone Medical Center, New York, NY.
Naomi WinickDepartment of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.
Michael BorowitzHematologic Pathology, Johns Hopkins University, Baltimore, MD.
Brent WoodDepartment of Laboratory Medicine, University of Washington, Seattle, WA.
Giuseppe BassoDepartment SDB, University of Padua, Padova, Italy.
Valentino ConterPediatric Clinics, University of Milano - Bicocca, Monza, Italy.
Martin ZimmermannPediatric Hematology and Oncology, Hannover Medical School, Hannover, Germany.
Stefan SuciuEORTC, EORTC Headquarters, Brussels, Belgium.
Andrea BiondiPediatric Clinics, University of Milano - Bicocca, Monza, Italy.
Martin SchrappeDepartment of Pediatrics, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Stephen P HungerDepartment of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
Maria Grazia ValsecchiCenter of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

backgroundThe aim of this study was to assess whether minimal residual disease (MRD) at the end of induction front-line treatment can serve as a surrogate endpoint for event-free survival (EFS) in childhood B-lineage acute lymphoblastic leukemia.

methodsThe analysis was based on individual data of 4830 patients from two large phase III trials that asked a randomized question on the effect of different corticosteroids (dexamethasone vs prednisone) during induction chemotherapy on EFS. The association between MRD classified in three ordered categories [negative = 0, low positive = (>0 and <5 × 10

resultsMRD at the end of induction was a poor surrogate for treatment effect on EFS at the trial level, with

conclusionsAlthough MRD is a robust biomarker highly predictive of outcome for individual patients, clinicians and regulatory bodies should be cautious in using early MRD response in the context of complex multiagent acute lymphoblastic leukemia therapy as an early surrogate endpoint to predict the effect of a randomized treatment intervention on long-term EFS.

Identifiers

PMID31360884
PMCPMC6649800

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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.