Etanercept, mycophenolate, denileukin or pentostatin plus corticosteroids for acute graft vs. host disease: a randomized phase II trial from the BMT CTN. Blood [Blood] Journal article | | Title | Etanercept, mycophenolate, denileukin or pentostatin plus corticosteroids for acute graft vs. host disease: a randomized phase II trial from the BMT CTN. | | Author(s) | Alousi AM, Weisdorf DJ, Logan BR, Bolanos-Meade J, Carter S, Difronzo N, Pasquini M, Goldstein SC, Ho VT, Hayes-Lattin B, Wingard JR, Horowitz MM, Levine JE | | Institution | University of Texas M. D. Anderson Cancer Center, Houston, TX, United States. | | Source | Blood 2009 May 14. | | Abstract | Acute graft versus host disease (AGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation (HCT). Corticosteroids remain the standard initial therapy, yet only 25-40% of patients completely respond (CR). This randomized, four-arm, phase II trial was designed to identify the most promising agent(s) for initial therapy for AGVHD. Patients were randomized to receive methylprednisolone 2 mg/kg/day plus etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin) or pentostatin. 180 patients were randomized; median age: 50 years (range, 7.5-70). Myeloablative conditioning represented 66% of transplants. Grafts were peripheral blood (PB, 61%), bone marrow (BM, 25%) or umbilical cord blood (UCB, 14%); 53% were from unrelated donors. Patients who received MMF for prophylaxis (24%) were randomized to a non-MMF arm. At randomization, AGVHD was grade I-II (68%), III-IV (32%) and (53%) had visceral organ involvement. Day 28 CR rates were etanercept 26%, MMF 60%, denileukin 53% and pentostatin 38%. Corresponding 9-month overall survival was 47%, 64%, 49% and 47%, respectively. Cumulative incidences of severe infections were: etanercept 48%, MMF 44%, denileukin 62%, and pentostatin 57%. Efficacy and toxicity data suggest MMF plus corticosteroids is the most promising regimen to compare against corticosteroids alone as initial AGVHD treatment in a definitive Phase III trial. This study is registered at http://www.clinicaltrials.gov as NCT00224874. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19443659 |
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