Chanan-Khan Asher, Miller Kena C, Musial Laurie, Lawrence David, Padmanabhan Swaminathan, Takeshita Kenichi, Porter Carl W, Goodrich David W, Bernstein Zale P, Wallace Paul, Spaner David, Mohr Alice, Byrne Catriona, Hernandez-Ilizaliturri Francisco, Chrystal Cynthia, Starostik Petr, Czuczman Myron S
Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
J Clin Oncol. 2006 Dec 1;24(34):5343-9. doi: 10.1200/JCO.2005.05.0401. Epub 2006 Nov 6.
Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options. Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL.
Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines. Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle. Response was assessed after each cycle. Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission. Rituximab was added to lenalidomide on disease progression.
Forty-five patients were enrolled, with a median age of 64 years. Sixty-four percent of the patients had Rai stage III or IV disease, and 51% were refractory to fludarabine. The overall response rate was 47%, with 9% of the patients attaining a complete remission. Fatigue, thrombocytopenia, and neutropenia were the most common adverse effects noted in 83%, 78%, and 78% of the patients, respectively.
Lenalidomide is clinically active in patients with relapsed or refractory B-CLL. These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.
复发或难治性慢性淋巴细胞白血病（CLL）患者存在严重的免疫缺陷且治疗选择有限。鉴于来那度胺在其他B细胞恶性肿瘤中具有显著活性及其多效性免疫调节作用，我们开展了一项来那度胺治疗CLL的II期试验。
复发或难治性B细胞CLL（B-CLL）患者，若根据美国国立癌症研究所工作组1996年指南需要治疗，则符合入组条件。来那度胺在28天周期的第1至21天口服，剂量为25mg。每个周期后评估疗效。患者持续治疗直至疾病进展、出现不可接受的毒性或完全缓解。疾病进展时在来那度胺基础上加用利妥昔单抗。
入组45例患者，中位年龄64岁。64%的患者为Rai III期或IV期疾病，51%的患者对氟达拉滨耐药。总缓解率为47%，9%的患者达到完全缓解。疲劳、血小板减少和中性粒细胞减少是最常见的不良反应分别见于83%、78%和78%的患者。
来那度胺对复发或难治性B-CLL患者具有临床活性。这些发现令人鼓舞，并值得对该药物在治疗这种疾病方面进行进一步研究。
