Evidence map›Paper›PMID 28495794›Full record

Observational studyBlood2017

An endpoint associated with clinical benefit after initial treatment of chronic graft-versus-host disease.

Paul J Martin, Barry E Storer, Yoshihiro Inamoto, Mary E D Flowers, Paul A Carpenter, Joseph Pidala, Jeanne Palmer, Mukta Arora, Madan Jagasia, Sally Arai and 2 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Blood, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00637689 (Improving Outcomes Assessment in Chronic GVHD), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT00637689 active not recruitingnot on this map

Improving Outcomes Assessment in Chronic GVHD

TypeobservationalSponsorFred Hutchinson Cancer CenterRan2007 to 2027Enrolled601ConditionsChronic Graft Versus Host Disease
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  4. Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  5. Trial
  6. ROCK2 Inhibition With Belumosudil (KD025) for the Treatment of Chronic Graft-Versus-Host Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Observational
  11. Advances in treatment of chronic graft-versus-host disease.International journal of hematology · 2026
    Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Observational
  17. Chronic GVHD: review advances in prevention, novel endpoints, and targeted strategies.Hematology. American Society of Hematology. Education Program · 2023
    Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 1 country.

Paul J MartinDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0001-9051-1215
Barry E StorerDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA.
Yoshihiro InamotoDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA.
Mary E D FlowersDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA.
Paul A CarpenterDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA.
Joseph PidalaBlood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL.
Jeanne PalmerDivision of Hematology/Oncology, Mayo Clinic, Phoenix, AZ.
Mukta AroraDepartment of Medicine, University of Minnesota, Minneapolis, MN.
Madan JagasiaDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN.
Sally AraiDepartment of Medicine, Stanford University Medical Center, Stanford, CA; and.
Corey S CutlerDepartment of Medicine, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA.
Stephanie J LeeDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA.
Fred Hutch Cancer Center · USHarvard University · USMayo Clinic Hospital · USMoffitt Cancer Center · USStanford Medicine · USUniversity of Minnesota · USUniversity of Washington · USVanderbilt University Medical Center · US

Funding

Improving Outcomes Assessment in Chronic GVHDR01CA118953 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2011 to 2025
$8.3M
Training and Career Development CoreU54CA163438 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2011 to 2014
$3.7M
Improving Outcomes Assessment in Chronic GVHDU01CA118953 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2007 to 2010
$3.1M
NCI NIH HHS R01 CA118953NCI NIH HHS U01 CA118953NCI NIH HHS U54 CA163438
6 · The paper itself

Abstract

No gold standard has been established as a primary endpoint in trials of initial treatment of chronic graft-versus-host disease (GVHD), and evidence showing the association of any proposed primary endpoint with clinical benefit has not been conclusively demonstrated. To address this gap, we analyzed outcomes in a cohort of 328 patients enrolled in a prospective, multicenter, observational study within 3 months after diagnosis of chronic GVHD. Complete and partial response, stable disease, and progressive disease were defined according to the 2014 National Institutes of Health Consensus Development Conference on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease. Success was defined as complete or partial response with no secondary systemic treatment or recurrent malignancy at 1 year after enrollment. Success was observed in fewer than 20% of the patients. The burden of disease manifestations at 1 year was lower for patients in this category than for those with stable or progressive disease. Systemic treatment ended earlier, and subsequent mortality was lower among patients with complete or partial response than among those with stable or progressive disease and those who had received secondary systemic treatment. We conclude that survival with a complete or partial response and no previous secondary systemic treatment or recurrent malignancy at 1 year after initial systemic therapy is associated with clinical benefit, a critical characteristic for consideration as a primary endpoint in a pivotal clinical trial. This prospective observational study was registered at www.clinicaltrials.gov as #NCT00637689.

Indexed as

Endpoint DeterminationHematopoietic Stem Cell TransplantationAdultAgedCalcineurin InhibitorsChronic DiseaseDisease ProgressionFemaleGraft vs Host DiseaseHematologic NeoplasmsHumansImmunosuppressive AgentsMaleMiddle AgedPhotopheresisPrednisoneCalcineurin InhibitorsImmunosuppressive AgentsPrednisoneRituximabSirolimus

Identifiers

PMID28495794
PMCPMC5520473
OpenAlexW2614093093

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.