Combination of Lenalidomide and Rituximab in Elderly Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Phase 2 Trial
Combination of Lenalidomide and Rituximab in Elderly Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Phase 2 Trial
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DOI：
10.1016/j.clml.2011.02.001
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发表时间：
2011-12-01
影响因子：
2.7
通讯作者：
Baccarani, Michele
中科院分区：
文献类型：
--
作者：
Zinzani, Pier Luigi;Pellegrini, Cinzia;Baccarani, Michele
弥漫性大b细胞淋巴瘤（DLBCL）是侵袭性非霍奇金淋巴瘤中最常见的亚型，尽管最近化疗取得了进展，但仍有多达一半的患者复发。我们进行了一项二期试验：口服来那度胺联合利妥昔单抗对老年复发/难治性DLBCL患者有效，在来那度胺维持后达到持续CR的患者比例很高。背景：弥漫性大b细胞淋巴瘤（DLBCL）是侵袭性非霍奇金淋巴瘤中最常见的亚型，尽管最近化疗取得进展，但仍有多达一半的患者复发。在此，我们报告了一项2期、单臂、单中心试验的结果，该试验评估了来那度胺联合利妥昔单抗治疗复发或难治性老年DLBCL患者的安全性和有效性。患者和方法：在2009年3月至6月期间，招募了经过大量预处理的复发/难治性DLBCL老年患者（65岁或以上）。口服来那度胺（20mg /d，每28天周期21天）开始4个周期，利妥昔单抗（375 mg/m(2)）在每28天周期的第1天和第21天给药，共4个周期。在诱导期后，达到完全缓解（CR）、部分缓解（PR）或疾病稳定（SD）的患者按相同的计划再给予来那度胺维持治疗8个月。结果：共纳入23例患者，既往治疗中位数为3次（范围2至8）。诱导期结束时总有效率（CR + PR）为35% （n = 8）。10例患者（7例CR， 1例PR， 2例SD）符合来那度胺维持治疗的条件，其中8例患者达到CR。不良事件可控，最常见的包括中性粒细胞减少症和血小板减少症。结论：口服来那度胺联合利妥昔单抗对老年复发/难治性DLBCL患者有效，患者在来那度胺维持后达到持续CR的比例很高。
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of aggressive non-Hodgkin lymphoma and despite recent chemotherapeutic advances up to half of all patients relapse. We conducted a phase two trial: oral lenalidomide in combination with rituximab is active in elderly patients with relapsed/refractory DLBCL with a high percentage of patients achieving a continuous CR after lenalidomide maintenance.Background: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of aggressive non-Hodgkin lymphoma and despite recent chemotherapeutic advances up to half of all patients relapse. Here we report the results from a phase 2, single-arm, single-center trial evaluating the safety and efficacy of lenalidomide plus rituximab in elderly patients with relapsed or refractory DLBCL. Patients and Methods: Between March and June 2009, elderly patients (65 years of age or older) with relapsed/refractory DLBCL who had been heavily pretreated were recruited. Oral lenalidomide (20 mg/d for 21 days of each 28-day cycle) was initiated for four cycles and rituximab (375 mg/m(2)) was administered on day 1 and day 21 of each 28-day cycle for four cycles. After this induction phase, patients achieving a complete response (CR), partial response (PR), or stable disease (SD) were given lenalidomide maintenance therapy at the same schedule for another 8 months. Results: A total of 23 patients with a median of three prior treatments (range, 2 to 8) were included. The overall response rate (CR + PR) at the end of the induction phase was 35% (n = 8). Ten patients (7 CR, 1 PR, and 2 SD patients) were eligible for lenalidomide maintenance and 8 of these patients achieved a CR. Adverse events were manageable and the most common included neutropenia and thrombocytopenia. Conclusion: Oral lenalidomide in combination with rituximab is active in elderly patients with relapsed/refractory DLBCL with a high percentage of patients achieving a continuous CR after lenalidomide maintenance.