Wiernik Peter H, Lossos Izidore S, Tuscano Joseph M, Justice Glen, Vose Julie M, Cole Craig E, Lam Wendy, McBride Kyle, Wride Kenton, Pietronigro Dennis, Takeshita Kenichi, Ervin-Haynes Annette, Zeldis Jerome B, Habermann Thomas M
Our Lady of Mercy Cancer Center, New York Medical College, Bronx, NY, USA.
J Clin Oncol. 2008 Oct 20;26(30):4952-7. doi: 10.1200/JCO.2007.15.3429. Epub 2008 Jul 7.
The major cause of death in aggressive lymphoma is relapse or nonresponse to initial therapy. Lenalidomide has activity in a variety of hematologic malignancies, including non-Hodgkin's lymphoma (NHL). We report the results of a phase II, single-arm, multicenter trial evaluating the safety and efficacy of lenalidomide oral monotherapy in patients with relapsed or refractory aggressive NHL.
Patients were treated with oral lenalidomide 25 mg once daily on days 1 to 21, every 28 days, for 52 weeks, until disease progression or intolerance. The primary end point was response; secondary end points included duration of response, progression-free survival (PFS), and safety.
Forty-nine patients with a median age of 65 years received lenalidomide in this study. The most common histology was diffuse large B-cell lymphoma (53%), and patients had received a median of four prior treatment regimens for NHL. An objective response rate of 35% was observed in 49 treated patients, including a 12% rate of complete response/unconfirmed complete response. Responses were observed in each aggressive histologic subtype tested (diffuse large B-cell, follicular center grade 3, mantle cell, and transformed lymphomas). Of patients with stable disease or partial response at first assessment, 25% improved with continued treatment. Estimated median duration of response was 6.2 months, and median PFS was 4.0 months. The most common grade 4 adverse events were neutropenia (8.2%) and thrombocytopenia (8.2%); the most common grade 3 adverse events were neutropenia (24.5%), leukopenia (14.3%), and thrombocytopenia (12.2%).
Oral lenalidomide monotherapy is active in relapsed or refractory aggressive NHL, with manageable side effects.
侵袭性淋巴瘤的主要死亡原因是复发或对初始治疗无反应。来那度胺在多种血液系统恶性肿瘤中具有活性，包括非霍奇金淋巴瘤（NHL）。我们报告了一项II期单臂多中心试验的结果，该试验评估了来那度胺口服单药治疗复发或难治性侵袭性NHL患者的安全性和疗效。
患者在第1至21天每天口服来那度胺25mg，每28天为一周期，共治疗52周，直至疾病进展或出现不耐受。主要终点为缓解；次要终点包括缓解持续时间、无进展生存期（PFS）和安全性。
本研究中49例患者接受了来那度胺治疗，中位年龄为65岁。最常见的组织学类型为弥漫性大B细胞淋巴瘤（53%），患者既往针对NHL接受的治疗方案中位数为4种。49例接受治疗的患者中观察到客观缓解率为35%，包括12%的完全缓解/未确认完全缓解率。在每种检测的侵袭性组织学亚型（弥漫性大B细胞、3级滤泡中心、套细胞和转化型淋巴瘤）中均观察到缓解。在首次评估时病情稳定或部分缓解的患者中，25%在继续治疗后病情改善。估计中位缓解持续时间为6.2个月，中位PFS为4.0个月。最常见的4级不良事件是中性粒细胞减少（8.2%）和血小板减少（8.2%）；最常见的3级不良事件是中性粒细胞减少（24.5%）、白细胞减少（14.3%）和血小板减少（12.2%）。
来那度胺口服单药治疗复发或难治性侵袭性NHL具有活性，且副作用可控。
