Phase II Study of Lenalidomide and Rituximab As Salvage Therapy for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Phase II Study of Lenalidomide and Rituximab As Salvage Therapy for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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DOI：
10.1200/jco.2012.42.8623
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发表时间：
2013-02-10
影响因子：
45.3
通讯作者：
Ferrajoli, Alessandra
中科院分区：
文献类型：
--
作者：
Badoux, Xavier C.;Keating, Michael J.;Ferrajoli, Alessandra
目的来那度胺是一种抢救慢性淋巴细胞白血病(CLL)的免疫调节药物。我们联合来那度胺和利妥昔单抗来提高复发或难治性CLL患者的有效率。患者和方法59例复发或难治性CLL患者参加来那度胺和利妥昔单抗的II期研究。患者以前接受过以氟达拉滨为基础的治疗或化学免疫治疗。利妥昔单抗(375 mg/m(2))于第1周期及第3~12周期第1天静脉滴注。来那度胺于第1周期第9天开始，每日10 mg，连续用药。每周期28天。结果来那度胺总有效率为66%，其中完全缓解12%，结节部分缓解12%。治疗失败的时间为17.4个月。中位总存活率尚未达到；估计36个月存活率为71%。最常见的3级或4级毒性是中性粒细胞减少(73%的患者)。14名患者(24%)经历了3-4级感染或发热。1例发生3级肿瘤溶解，1例在治疗第一周期发生肾功能衰竭，1例发生静脉血栓栓塞症。结论来那度胺联合利妥昔单抗治疗复发性CLL有效，值得进一步研究。J Clin Oncol31：584-591。(C)2012年美国临床肿瘤学会
PurposeLenalidomide is an immunomodulatory drug active as salvage therapy for chronic lymphocytic leukemia (CLL). We combined lenalidomide with rituximab to improve response rates in patients with relapsed or refractory CLL.Patients and MethodsFifty-nine adult patients (age 42 to 82 years) with relapsed or refractory CLL were enrolled onto a phase II study of lenalidomide and rituximab. Patients had received prior fludarabine-based therapy or chemoimmunotherapy. Rituximab (375 mg/m(2) intravenously) was administered weekly during cycle one and on day 1 of cycles three to 12. Lenalidomide was started on day 9 of cycle one at 10 mg orally and administered daily continuously. Each cycle was 28 days. Rituximab was administered for 12 cycles; lenalidomide could continue indefinitely if patients benefitted clinically.ResultsThe overall response rate was 66%, including 12% complete responses and 12% nodular partial remissions. Time to treatment failure was 17.4 months. Median overall survival has not been reached; estimated survival at 36 months is 71%. The most common grade 3 or 4 toxicity was neutropenia (73% of patients). Fourteen patients (24%) experienced a grade 3 to 4 infection or febrile episode. There was one episode of grade 3 tumor lysis; one patient experienced renal failure during the first cycle of therapy, and one venous thromboembolic event occurred during the study.ConclusionThe combination of lenalidomide and rituximab is active in patients with recurrent CLL and warrants further investigation. J Clin Oncol 31:584-591. (C) 2012 by American Society of Clinical Oncology