Evidence map›Paper›PMID 36868525›Full record

ArticleInternational journal of radiation oncology, biology, physics2023

Importance of Central Imaging Review in a Pediatric Hodgkin Lymphoma Trial Using Positron Emission Tomography Response Adapted Radiation Therapy.

Bradford S Hoppe, Kathleen M McCarten, Qinglin Pei, Sandy Kessel, Adina Alazraki, Joyce C Mhlanga, Hollie A Lai, Eric Eutsler, David C Hodgson, Kenneth B Roberts and 7 more

Registry-linked trialAbstract read
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02166463 (A Randomized Phase 3 Study of Brentuximab Vedotin), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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.

NCT02166463 phase3active not recruitingnot on this map

A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2015 to 2026Enrolled600ConditionsAnn Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin LymphomaArmsBleomycin Sulfate, Brentuximab Vedotin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. 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

17 authors.

Bradford S HoppeDepartment of Radiation Oncology, Mayo Clinic, Jacksonville, Florida. Electronic address: hoppe.bradford@mayo.edu.
Kathleen M McCartenPediatric Radiology, Imaging and Radiation Oncology Core Rhode Island, Lincoln, Rhode Island.
Qinglin PeiChildren's Oncology Group Statistics and Data Center, Department of Biostatistics, University of Florida, Gainesville, Florida.
Sandy KesselPediatric Radiology, Imaging and Radiation Oncology Core Rhode Island, Lincoln, Rhode Island.
Adina AlazrakiDepartment of Radiology and Imaging Sciences, Emory University and Children's Healthcare of Atlanta-Egleston Hospital, Decatur, Georgia.
Joyce C MhlangaMallinckrodt Institute of Radiology, Washington University, St. Louis, Missouri.
Hollie A LaiDepartment of Radiology, Children's Health of Orange County, Orange, California.
Eric EutslerDepartment of Radiology, Progressive Physician Associates, Bethlehem, Pennsylvania.
David C HodgsonDepartment of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Kenneth B RobertsDepartment of Therapeutic Radiology, Yale University, New Haven, Connecticut.
Anne-Marie CharpentierDepartment of Radiation Oncology, Centre Hospitalier de l'Universite de Montreal, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.
Frank G KellerAflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, Georgia.
Stephan D VossDepartment of Radiology, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.
Yue WuChildren's Oncology Group Statistics and Data Center, Department of Biostatistics, University of Florida, Gainesville, Florida.
Steve Y ChoDepartment of Radiology, Wisconsin Institutes for Medical Research, University of Wisconsin, Madison, Wisconsin.
Kara M KellyDepartment of Pediatrics, Roswell Park Comprehensive Cancer Center, University at Buffalo, Buffalo, New York.
Sharon M CastellinoAflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, Georgia.

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
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS U24 CA180803
6 · The paper itself

Abstract

purposeWe investigated the effects of central review of the interim fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) scan response (iPET) assessment on treatment allocation in the risk-based, response-adapted, Children's Oncology Group study AHOD1331 (ClinicalTrials.gov identifier: NCT02166463) for pediatric patients with high-risk Hodgkin lymphoma. METHODS AND MATERIALS: Per protocol, after 2 cycles of systemic therapy, patients underwent iPET, with visual response assessment by 5-point Deauville score (DS) at their treating institution and a real-time central review, with the latter considered the reference standard. An area of disease with a DS of 1 to 3 was considered a rapid-responding lesion, whereas a DS of 4 to 5 was considered a slow-responding lesion (SRL). Patients with 1 or more SRLs were considered iPET positive, whereas patients with only rapid-responding lesions were considered iPET negative. We conducted a predefined exploratory evaluation of concordance in iPET response assessment between institutional and central reviews of 573 patients. The concordance rate was evaluated using the Cohen κ statistic (κ > 0.80 was considered very good agreement and κ > 0.60-0.80, good agreement).

resultsThe concordance rate (514 of 573 [89.7%]) had a κ of 0.685 (95% CI, 0.610-0.759), consistent with good agreement. In terms of the direction of discordance, among the 126 patients who were considered iPET positive by institutional review, 38 (30.2%) were categorized as iPET negative by central review, preventing overtreatment with radiation therapy. Conversely, among the 447 patients who were considered iPET negative by institutional review, 21 patients (4.7%) were categorized as iPET positive by the central review and would have been undertreated without radiation therapy.

conclusionsCentral review is integral to PET response-adapted clinical trials for children with Hodgkin lymphoma. Continued support of central imaging review and education about DS are needed.

Indexed as

Hodgkin DiseaseChildFluorodeoxyglucose F18HumansPositron-Emission TomographyPositron Emission Tomography Computed TomographyFluorodeoxyglucose F18

Identifiers

PMID36868525
PMCPMC10363760

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Registered trials

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.