Phase 2 study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia
Phase 2 study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia
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DOI：
10.1182/blood-2003-01-0014
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发表时间：
2003-08-01
期刊：
影响因子：
20.3
通讯作者：
Saven, A
中科院分区：
文献类型：
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作者：
Nieva, J;Bethel, K;Saven, A
毛细胞白血病（HCL）是一种惰性B细胞肿瘤，强烈表达CD 20。尽管克拉屈滨治疗后的初始应答率非常高，但许多患者（pts）最终复发。24例中位年龄为53.5岁的HCL患者（21例男性，3例女性）在既往接受克拉屈滨治疗后复发，接受利妥昔单抗375 mg/m2静脉注射治疗，每周一次，持续4周。在患者中，3例（13%）完全缓解，3例（13%）部分缓解。因此，24例患者中有6例（25%）在利妥昔单抗治疗后获得了缓解。在中位随访14.6个月时，2例应答者复发;尚未达到中位复发时间。唯一的III级或IV级毒性表现为培养阴性发热性中性粒细胞减少症、与利妥昔单抗给药相关的一过性和可逆性弥散性血管内凝血以及憩室性脓肿，均发生在单个患者中。在18例无应答者中，9例患者随后接受其他治疗; 5例患者接受克拉屈滨复治，3例接受脾切除术，1例接受喷司他丁。这9例患者中有7例的随访数据可用;所有7例患者的血液学参数均获得改善。利妥昔单抗，在这个剂量和时间表管理，只有适度的单药活性克拉屈滨失败HCL患者相比，其他药物在这种疾病的活动。
Hairy cell leukemia (HCL) is an indolent B-cell neoplasm, strongly expressing CD20. Despite initial very high response rates following cladribine, many patients (pts) ultimately relapse. Having relapsed after prior treatment with cladribine, 24 HCL pts (21 male, 3 female) with a median age of 53.5 years were treated with rituximab at 375 mg/m(2) intravenously weekly for 4 weeks. Of the pts, 3 (13%) achieved complete remissions and 3 (13%), partial responses. Thus, 6 (25%) of 24 pts achieved a response following rituximab. At a median follow-up of 14.6 months, 2 responders have relapsed; median time to relapse was not yet reached. The only grade III or IV toxicities demonstrated were culture-negative febrile neutropenia, transient and reversible disseminated intravascular coagulation related to rituximab administration, and a diverticular abscess, each in single patients. Of 18 nonresponders, 9 pts subsequently received other treatments; 5 pts were retreated with cladribine, 3 underwent splenectomy, and 1 received pentostatin. Follow-up data are available on 7 of these 9 patients; all 7 patients achieved improvements in hematologic parameters. Rituximab, administered at this dose and schedule, has only modest single-agent activity in cladribine-failed HCL patients when compared with other agents active in this disease.