The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
Leuk Lymphoma. 2009 Oct;50(10):1589-96. doi: 10.1080/10428190903150839.
The humanized anti-CD52 monoclonal antibody alemtuzumab is an effective therapy for chronic lymphocytic leukemia (CLL). We examined the impact of alemtuzumab treatment after initial fludarabine treatment for feasibility and safety. Patients (N = 85) with previously untreated symptomatic CLL received fludarabine (25 mg/m(2)/day) for 5 days every 4 weeks for four cycles followed by 2 months of observation. Patients with stable disease or better response then received alemtuzumab 30 mg three times weekly for 6 weeks either intravenously (IV; cohort 1; N = 39) or subcutaneously (SC; cohort 2; N = 20). Of the 85 evaluable patients enrolled on our study, four (5%) attained a complete response (CR) and 43 (51%) attained a partial response after fludarabine induction for an overall response rate (ORR) of 55%. Thirty-nine patients received IV alemtuzumab for consolidation with improvement in CR to 27% and ORR to 73%. Twenty patients received SC alemtuzumab consolidation with improvement in CR to 17% and ORR to 69%. Toxicity from IV alemtuzumab included infusion-related reactions and infection. Mild local inflammation was common from SC alemtuzumab but there were virtually no systemic side effects. Nine of 59 (15%) patients had cytomegalovirus (CMV) infections; one patient died. The administration of alemtuzumab as consolidation therapy following an abbreviated fludarabine induction is feasible but requires close monitoring for CMV infection and other infectious events.
人源化抗 CD52 单克隆抗体阿仑单抗是治疗慢性淋巴细胞白血病（CLL）的有效药物。我们研究了阿仑单抗治疗在氟达拉滨初始治疗后的可行性和安全性。先前未经治疗且有症状的 CLL 患者（N = 85）接受氟达拉滨（25 mg/m(2)/天）治疗，每 4 周 5 天，共 4 个周期，然后观察 2 个月。疾病稳定或有更好反应的患者接受阿仑单抗 30 mg，每周 3 次，共 6 周，静脉内（IV；队列 1；N = 39）或皮下（SC；队列 2；N = 20）。在我们的研究中，85 例可评估患者中有 4 例（5%）达到完全缓解（CR），43 例（51%）在氟达拉滨诱导后达到部分缓解，总缓解率（ORR）为 55%。39 例患者接受 IV 阿仑单抗巩固治疗，CR 改善至 27%，ORR 改善至 73%。20 例患者接受 SC 阿仑单抗巩固治疗，CR 改善至 17%，ORR 改善至 69%。IV 阿仑单抗的毒性包括输注相关反应和感染。SC 阿仑单抗常见轻度局部炎症，但几乎没有全身副作用。59 例患者中有 9 例（15%）发生巨细胞病毒（CMV）感染；1 例患者死亡。在氟达拉滨简短诱导治疗后，用阿仑单抗作为巩固治疗是可行的，但需要密切监测 CMV 感染和其他感染事件。
