Premium
Optimal dose of rabbit thymoglobulin in conditioning regimens for unmanipulated, haploidentical, hematopoietic stem cell transplantation: Long‐term outcomes of a prospective randomized trial
Author(s) -
Chang YingJun,
Wang Yu,
Mo XiaoDong,
Zhang XiaoHui,
Xu LanPing,
Yan ChenHua,
Chen Huan,
Chen YuHong,
Chen Yao,
Han Wei,
Wang FengRong,
Wang JingZhi,
Liu KaiYan,
Huang XiaoJun
Publication year - 2017
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30540
Subject(s) - thymoglobulin , medicine , cumulative incidence , hematopoietic stem cell transplantation , transplantation , gastroenterology , graft versus host disease , incidence (geometry) , population , prospective cohort study , randomized controlled trial , surgery , kidney transplantation , physics , environmental health , optics
BACKGROUND Antithymocyte globulin (ATG) is an important component of conditioning regimens to prevent severe graft‐versus‐host disease (GVHD) in patients undergoing unmanipulated, haploidentical stem cell transplantation (haplo‐SCT). However, to the authors' knowledge, the optimal dose of ATG is unknown. METHODS In this prospective, randomized trial, the authors compared the long‐term outcomes of 2 ATG doses (rabbit thymoglobulin) used in myeloablative conditioning before unmanipulated haplo‐HSCT. Patients were randomly assigned (1:1) to received 10 mg/kg (ATG‐10) or 6 mg/kg (ATG‐6) of ATG. Analysis of disease‐free survival, GVHD‐free/recurrence‐free survival (GRFS), disease recurrence, nonrecurrence mortality, and chronic GVHD (cGVHD) included the entire population. Late effects were assessed in disease‐free patients who had survived for at least 6 months and had received regular follow‐up evaluations. RESULTS A total of 224 patients were recruited. The median follow‐up period was 1614 days (range, 28‐1929 days). The rate of infection‐related deaths in ATG‐10 arm was double that of the ATG‐6 arm (14.3% vs 7.1%; P = .084). The 5‐year cumulative incidence was comparable between the ATG‐6 and ATG‐10 groups for disease recurrence (12.8% vs 13.4%; P = .832) and nonrecurrence mortality (11.6% vs 17.0%; P = .263). The 5‐year probability of disease‐free survival was comparable between the groups (75.6% vs 69.6%; P = .283). The 5‐year cumulative incidence of cGVHD was found to be higher with ATG‐6 (75.0% vs 56.3% [ P = .007] and moderate‐to‐severe cGVHD: 56.3% vs 30.4% [ P <.0001]) as well as that for late effects (71.2% vs 56.9%; P = .043). The 5‐year probability of GRFS was higher in the ATG‐10 group (41.0% vs 26.8%; P = .008). In the multivariate analysis, ATG‐10 was found to be associated with a lower risk of cGVHD and improved GRFS. CONCLUSIONS ATG‐10 was found to be associated with better GVHD prevention and superior GRFS, but an increase in infection‐related deaths. Cancer 2017;123:2881–92. © 2017 American Cancer Society .