Long-term outcome and prospective validation of NIH response criteria in 39 patients receiving imatinib for steroid-refractory chronic GVHD

Blood. 2013 Dec 12;122(25):4111-8. doi: 10.1182/blood-2013-05-494278. Epub 2013 Oct 23.

Abstract

Forty adults aged 28 to 73 years were entered into a prospective trial of imatinib for the treatment of steroid-refractory chronic graft-versus-host disease (SR-cGVHD). After 6 months, intention-to-treat (ITT) analysis of 39 patients who received the drug, regardless of the duration of treatment, revealed 14 partial responses (PR), 4 minor responses (MR) with relevant steroid sparing (46%) according to Couriel criteria, and 20 ≥ PR (51.3%), as per the National Institutes of Health (NIH) criteria and NIH severity score changes. The best responses were seen in the lungs, gut, and skin (35%, 50%, and 32%, respectively). After a median follow-up of 40 months, 28 patients were alive, with a 3-year overall survival (OS) and event-free survival of 72% and 46%, respectively. The 3-year OS was 94% for patients responding at 6 months and 58% for nonresponders according to NIH response, suggesting that these criteria represent a reliable tool for predicting OS after second-line treatment. Monitoring of anti-platelet-derived growth factor receptor (PDGF-R) antibodies showed a significant decrease in PDGF-R stimulatory activity in 7 responders, whereas it remained high in 4 nonresponders. This study confirms the efficacy of imatinib against SR-cGVHD and suggests that the response at 6 months significantly predicts long-term survival.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Hormonal / administration & dosage
  • Antineoplastic Agents, Hormonal / adverse effects
  • Autoantibodies / blood
  • Benzamides / administration & dosage*
  • Benzamides / adverse effects
  • Chronic Disease
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Graft vs Host Disease / blood
  • Graft vs Host Disease / drug therapy*
  • Graft vs Host Disease / mortality*
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Imatinib Mesylate
  • Lymphoproliferative Disorders
  • Male
  • Middle Aged
  • Monitoring, Physiologic / methods
  • Myeloproliferative Disorders / mortality
  • Myeloproliferative Disorders / therapy
  • Piperazines / administration & dosage*
  • Piperazines / adverse effects
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects
  • Prospective Studies
  • Protein Kinase Inhibitors / administration & dosage*
  • Protein Kinase Inhibitors / adverse effects
  • Pyrimidines / administration & dosage*
  • Pyrimidines / adverse effects
  • Receptors, Platelet-Derived Growth Factor / blood
  • Severity of Illness Index
  • Survival Rate
  • Time Factors

Substances

  • Antineoplastic Agents, Hormonal
  • Autoantibodies
  • Benzamides
  • Piperazines
  • Protein Kinase Inhibitors
  • Pyrimidines
  • Imatinib Mesylate
  • Prednisolone
  • Receptors, Platelet-Derived Growth Factor

Associated data

  • EudraCT/2009-012927-27