A prospective randomized trial comparing cyclosporine and short course methotrexate with cyclosporine and mycophenolate mofetil for GVHD prophylaxis in myeloablative allogeneic bone marrow transplantation
A prospective randomized trial comparing cyclosporine and short course methotrexate with cyclosporine and mycophenolate mofetil for GVHD prophylaxis in myeloablative allogeneic bone marrow transplantation
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DOI：
10.1038/sj.bmt.1704647
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发表时间：
2004-10-01
影响因子：
4.8
通讯作者：
Kalaycio, M
中科院分区：
文献类型：
--
作者：
Bolwell, B;Sobecks, R;Kalaycio, M
环孢菌素（CSP）和短程甲氨蝶呤（MTX）几十年来一直是GVHD预防的金标准。与MTX相关的问题包括造血植入时间增加、粘膜炎和其他器官毒性。CSP联合霉酚酸酯（MMF）已成功用于预防非清髓性移植中的移植物排斥反应和GVHD。我们进行了一项前瞻性随机试验，比较CSP和MTX与CSP和MMF在清髓性（白消安为基础）异基因6/6匹配同胞骨髓移植（BMT）中的作用。接受MMF组（n = 21）的严重粘膜炎明显低于接受MTX组（n = 19）（21 vs 65%，P = 0.008）。MMF组中性粒细胞植入的中位时间更快（11天vs 18天，P < 0.001）。两组的急性GVHD发生率以及100天存活率相似。CSP和MMF组的毒性降低导致研究提前关闭。我们的结论是，与CSP和MTX相比，在清髓性同种异体准备方案后CSP和MMF的GVHD预防方案与更快的造血移植、更低的粘膜炎发生率、相似的aGVHD发生率和相当的生存率相关。
Cyclosporine (CSP) and short course methotrexate (MTX) have been the gold standard for GVHD prophylaxis for decades. Problems associated with MTX include increased time to hematopoietic engraftment, mucositis, and other organ toxicities. The combination of CSP with mycophenolate mofetil (MMF) has been used successfully for the prevention of graft rejection and GVHD in nonmyeloablative transplantation. We performed a prospective randomized trial comparing CSP and MTX with CSP and MMF in myeloablative (busulfan based) allogeneic 6/6 matched sibling bone marrow transplantation (BMT). The group receiving MMF (n = 21) had significantly less severe mucositis than did the group receiving MTX (n = 19) (21 vs 65%, P = 0.008). Median time to neutrophil engraftment was more rapid in the MMF group (11 vs 18 days, P < 0.001). The incidence of acute GVHD, as well as 100 day survival, was similar for both groups. The reduced toxicity of the CSP and MMF arm resulted in premature study closure. We conclude that a GVHD prophylaxis regimen of CSP and MMF after a myeloablative allogeneic preparative regimen is associated with faster hematopoietic engraftment, decreased incidence of mucositis, similar incidence of aGVHD, and comparable survival as compared to CSP and MTX.