Low incidence of severe cGvHD and late NRM in a phase II trial of thymoglobulin, tacrolimus and sirolimus for GvHD prevention

• Type of Material: Article
• Authors: Zaid Al-Kadhimi, Emory University; Z. Gul, University of Cincinnati; M. Abidi, Spectrum Health; L.G. Lum, University of Virginia; A. Deol, Wayne State University; W. Chen, Wayne State University; H. Jang, Wayne State University; C. Ozust, Infinity Primary Care; Amelia Langston, Emory University; Edmund Waller, Emory University; J. Uberti, Wayne State University
• Language: English
• Date: 2017-09-01
• Publisher: NATURE PUBLISHING GROUP
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017, Macmillan Publishers Limited, part of Springer Nature.
• Final Published Version (URL): http://dx.doi.org/10.1038/bmt.2017.95
• Title of Journal or Parent Work: BONE MARROW TRANSPLANTATION
• Volume: 52
• Issue: 9
• Start Page: 1304
• End Page: 1310
• Keywords: ANTITHYMOCYTE GLOBULIN; Biophysics; BONE-MARROW-TRANSPLANTATION; RANDOMIZED-TRIAL; ALLOGENEIC TRANSPLANTATION; Science & Technology; VERSUS-HOST-DISEASE; Immunology; UNRELATED DONORS; Oncology; Life Sciences & Biomedicine; CHRONIC GRAFT; Transplantation; FOLLOW-UP; Hematology; STEM-CELL TRANSPLANTATION; LONG-TERM SURVIVAL
• Research Categories: Health Sciences, Immunology; Health Sciences, Medicine and Surgery; Health Sciences, Oncology

Abstract

Chronic GvHD (cGvHD) is the leading cause of late non-relapse mortality (NRM) and morbidity after allogeneic hematopoietic stem cell transplant (AHSCT). We analyzed the late effects of a phase II trial testing the efficacy of intermediate dose rabbit anti-thymocyte globulin (Thymoglobulin Thymo) in combination with tacrolimus and sirolimus (TTS) in 47 patients (pts) for the prevention of acute and chronic GvHD after unrelated AHSCT. The median follow-up was 45.2 months. The cumulative incidence of NIH severe cGvHD at 48 months was 6.4% with no new occurrences past 6 months for the entire follow-up period. The overall cumulative incidence of cGvHD was 44.7%. Out of 20 pts who are alive and disease-free at the last follow-up, only 4 pts continue to need systemic immune suppression. We observed low late NRM with only 3 transplant-related deaths after 6 months post transplant. At 4 years of follow-up, the overall cumulative incidence of NRM and disease relapse was 27.7% and 30.0%, respectively. PFS and overall survival (OS) at 4 years were 42 and 47%. At long term follow-up, TTS was associated with low incidence of severe cGvHD and late NRM.