Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graftversus-Host Disease and Graft-versus-Host Disease_Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial
Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graftversus-Host Disease and Graft-versus-Host Disease_Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial
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低剂量糖皮质激素预防对慢性移植物抗宿主病和移植物抗宿主病的影响_单倍体移植后无复发生存：对照随机开放标签试验的长期随访
DOI：
10.1016/j.bbmt.2018.11.020
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通讯作者：
Xiao-Jun Huang
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作者：
Ying-Jun Chang;Lan-Ping Xu;Lan-Ping Xu;Xiao-Hui Zhang;Huan-Chen;Yu-Hong Chen;Feng-Rong Wang;Wei Han;Yu-Qian Sun;Fei-Fei Tang;Xiao-Dong Mo;Kai-Yan Liu;Xiao-Jun Huang
这项长期随访研究评价了皮质类固醇预防对无移植物抗宿主病（GVHD）、无复发生存期（GRFS）的影响，该研究基于一项对照、开放标签、随机试验，其中228例同种异体移植受者被归类为低风险A组83例，高危组72例; B组B组72例，高危组73例，随机分为低剂量甲泼尼龙预防组和不预防组。慢性GVHD、复发、非复发死亡率、无白血病生存率、总生存率和GRFS的累积发生率分别为60%、19%、16%、68%、73%和46%。与C组相比，B组中重度慢性GVHD的累积发生率较低（42%对20%;P = .010），带状疱疹感染（28%对12%;P = .010），肺部感染（42%对21%;P = 0.040）和股骨头坏死（ONFH; 16%对6%;P = 0.045）以及更好的GRFS（59%对33%;P = 0.017）。与GRFS相关的因素包括移植后100天内使用的皮质类固醇总剂量（风险比，1.547;P= .015）和血小板恢复（风险比，1.456;P= .037）。我们的研究结果表明，低剂量糖皮质激素预防减少GVHD，从而减少类固醇的总剂量，这可能有助于降低感染和ONFH的发生率和上级的GRFS，表明较高的类固醇剂量是有害的。减少总剂量当然是有益的。（ClinicalTrials.gov编号，NCT 01607580。）
This long-term follow-up study evaluated the effects of corticosteroid prophylaxis on graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) based on a controlled open-label randomized trial in which 228 allotransplant recipients were categorized as low risk (n = 83, group A) or high risk; patients at high risk were randomly assigned to receive (n = 72, group B) or not receive (n = 73, group C) low-dose methylprednisolone prophylaxis. The cumulative incidences of chronic GVHD, relapse, nonrelapse mortality, leukemia-free survival, overall survival, and GRFS were 60%, 19%, 16%, 68%, 73%, and 46%, respectively, in all cases. Compared with the patients in group C, the cases in group B experienced a lower cumulative incidence of moderate to severe chronic GVHD (42% versus 20%;P = .010), herpes zoster infection (28% versus 12%;P = .010), pulmonary infections (42% versus 21%;P = .040), and osteonecrosis of the femoral head (ONFH; 16% versus 6%;P = .045) as well as better GRFS (59% versus 33%;P = .017). Factors associated with GRFS included total dose of corticosteroid used in the first 100days after transplantation (hazard ratio, 1.547;P= .015) and platelet recovery (hazard ratio, 1.456;P= .037). Our results suggest that low-dose glucocorticoid prophylaxis reduces GVHD and thus reduces the total dose of steroids, which might contribute to lower incidence of infections and ONFH and a superior GRFS, indicating that higher steroid doses are harmful. Reducing the total dose is of course beneficial. (ClinicalTrials.gov number, NCT01607580.)