Royal Free Hampstead National Health Service (NHS) Trust, London, United Kingdom.
Blood. 2010 Oct 21;116(16):3080-8. doi: 10.1182/blood-2010-05-286856. Epub 2010 Jun 29.
In vivo alemtuzumab reduces the risk of graft-versus-host disease (GVHD) and nonrelapse mortality after reduced intensity allogeneic transplantation. However, it also delays immune reconstitution, leading to frequent infections and potential loss of graft-versus-tumor responses. Here, we tested the feasibility of alemtuzumab dose deescalation in the context of fludarabine-melphalan conditioning and human leukocyte antigen (HLA)-identical sibling transplantation. Alemtuzumab was given 1-2 days before graft infusion, and dose reduced from 60 mg to 20 mg in 4 sequential cohorts (total n = 106). Pharmacokinetic studies were fitted to a linear, 2-compartment model in which dose reduction led to incomplete saturation of CD52 binding sites and greater antibody clearance. Increased elimination was particularly evident in the 20-mg group in patients who had CD52-expressing tumors at time of transplantation. The 20-mg dose was also associated with greater risk of severe GVHD (acute grade III-IV or chronic extensive) compared with > 20 mg (hazard ratio, 6.7; 95% CI, 2.5-18.3). In contrast, dose reduction to 30 mg on day -1 was associated with equivalent clinical outcomes to higher doses but better lymphocyte recovery at 12 months. In conclusion, alemtuzumab dose reduction to 30 mg is safe in the context of reduced intensity conditioning and HLA-identical sibling transplantation. This trial was registered at http://www.ncrn.org.uk as UKCRN study 1415.
在体内使用阿仑单抗可降低减低强度异基因移植后移植物抗宿主病(GVHD)和非复发死亡率的风险。然而,它也会延迟免疫重建,导致频繁感染和潜在的丧失移植物抗肿瘤反应。在这里,我们测试了在氟达拉滨-美法仑预处理和 HLA 相同的同胞移植背景下降低阿仑单抗剂量的可行性。阿仑单抗在移植前 1-2 天给予,并在 4 个连续队列中从 60mg 减少到 20mg(总 n = 106)。药代动力学研究采用线性、双室模型拟合,其中剂量减少导致 CD52 结合位点不完全饱和和抗体清除增加。在移植时患有 CD52 表达肿瘤的患者中,20mg 组的清除增加尤为明显。与 > 20mg 相比,20mg 剂量与更严重的 GVHD(急性 3 级-4 级或慢性广泛)风险增加相关(危险比,6.7;95%CI,2.5-18.3)。相比之下,在减低强度预处理和 HLA 相同的同胞移植背景下,在第 -1 天减少至 30mg 的剂量与较高剂量具有等效的临床结局,但 12 个月时淋巴细胞恢复更好。总之,在减低强度预处理和 HLA 相同的同胞移植背景下,阿仑单抗剂量减少至 30mg 是安全的。该试验在 http://www.ncrn.org.uk 上注册为 UKCRN 研究 1415。