Evidence map›Paper›PMID 25017765›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2014

A phase II study of bortezomib plus prednisone for initial therapy of chronic graft-versus-host disease.

Alex F Herrera, Haesook T Kim, Bhavjot Bindra, Kyle T Jones, Edwin P Alyea, Philippe Armand, Corey S Cutler, Vincent T Ho, Sarah Nikiforow, Bruce R Blazar and 4 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
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.

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

26 citing papers in PubMed, 48 citations in OpenAlex.

  1. Ixazomib for Chronic Graft-versus-Host Disease Prophylaxis following Allogeneic Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2020
    Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. [Progress in second-line treatment of chronic graft-versus-host disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2019
    Article
  10. Review
  11. Review
  12. New and emerging therapies for acute and chronic graftTherapeutic advances in hematology · 2018
    Review
  13. Review
  14. Cytokine mediators of chronic graft-versus-host disease.The Journal of clinical investigation · 2017
    Review
  15. Targeting the Canonical Nuclear Factor-κB Pathway with a High-Potency IKK2 Inhibitor Improves Outcomes in a Mouse Model of Idiopathic Pneumonia Syndrome.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Article
  16. Review
  17. Review
  18. Article
  19. [Progress of chronic graft-versus-host disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2016
    Article
  20. Altered Exosomal RNA Profiles in Bronchoalveolar Lavage from Lung Transplants with Acute Rejection.American journal of respiratory and critical care medicine · 2015
    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

14 authors at 3 institutions in 1 country.

Alex F HerreraDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Haesook T KimDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Bhavjot BindraDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Kyle T JonesDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Edwin P AlyeaDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Philippe ArmandDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Corey S CutlerDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Vincent T HoDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Sarah NikiforowDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Bruce R BlazarBlood and Marrow Transplantation, University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota.
Jerome RitzDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Joseph H AntinDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
Robert J SoifferDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.
John KorethDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: john_koreth@dfci.harvard.edu.
Dana-Farber Cancer Institute · USHarvard University · USUniversity of Minnesota Medical Center · US

Funding

Transgenic/KnockoutP01AI056299 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI BLAZAR, BRUCE R · 2003 to 2023
$42.5M
Project 3: Humoral Targets and B Cell Biology in Chronic Graft-vs.-Host DiseaseP01CA142106 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME · 2009 to 2019
$17.5M
Physician Scientist Training in Cancer ResearchT32CA009172 · NCI · DANA-FARBER CANCER INSTITUTE · PI Jennifer R Brown, James A. DeCaprio · 1985 to 2026
$17.1M
Manipulation of Immune Responsiveness after Hematopoietic Cell TransplantationR01CA183559 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME, SOIFFER, ROBERT JON · 2013 to 2017
$3.7M
Random Trial of CD8 T-Cell Depletion in PBSC TransplantationU01HL069249 · NHLBI · DANA-FARBER CANCER INSTITUTE · PI ANTIN, JOSEPH H · 2001 to 2010
$2.1M
NCI NIH HHS P01 CA142106NCI NIH HHS R01 CA183559NCI NIH HHS T32 CA009172NHLBI NIH HHS U01 HL069249NIAID NIH HHS P01 AI056299
6 · The paper itself

Abstract

Chronic graft-versus-host disease (GVHD) induces significant morbidity and mortality after allogeneic hematopoietic stem cell transplantation. Corticosteroids are standard initial therapy, despite limited efficacy and long-term toxicity. Based on our experience using bortezomib as effective acute GVHD prophylaxis, we hypothesized that proteasome-inhibition would complement the immunomodulatory effects of corticosteroids to improve outcomes in chronic GVHD (cGVHD). We undertook a single-arm phase II trial of bortezomib plus prednisone for initial therapy of cGVHD. Bortezomib was administered at 1.3 mg/m(2) i.v. on days 1, 8, 15, and 22 of each 35-day cycle for 3 cycles (15 weeks). Prednisone was dosed at .5 to 1 mg/kg/day, with a suggested taper after cycle 1. All 22 enrolled participants were evaluable for toxicity; 20 were evaluable for response. Bortezomib plus prednisone therapy was well tolerated, with 1 occurrence of grade 3 sensory peripheral neuropathy possibly related to bortezomib. The overall response rate at week 15 in evaluable participants was 80%, including 2 (10%) complete and 14 (70%) partial responses. The organ-specific complete response rate was 73% for skin, 53% for liver, 75% for gastrointestinal tract, and 33% for joint, muscle, or fascia involvement. The median prednisone dose decreased from 50 mg/day to 20 mg/day at week 15 (P < .001). The combination of bortezomib and prednisone for initial treatment of cGVHD is feasible and well tolerated. We observed a high response rate to combined bortezomib and prednisone therapy; however, in this single-arm study, we could not directly measure the impact of bortezomib. Proteasome inhibition may offer benefit in the treatment of cGVHD and should be further evaluated.

Indexed as

AdultAgedAntineoplastic AgentsBoronic AcidsBortezomibChronic DiseaseCohort StudiesFemaleGraft vs Host DiseaseHumansMaleMiddle AgedPrednisoneProspective StudiesPyrazinesAntineoplastic AgentsBoronic AcidsBortezomibPrednisonePyrazinesChronic graft-versus-host diseaseGraft-versus-host diseaseHematopoietic stem cell transplantationProteasome inhibition

Identifiers

PMID25017765
PMCPMC4465759
OpenAlexW2103122153

What OpenQuestion holds

Textmetadata
LicenceTDM
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.