文章：

来那度胺治疗复发或难治性慢性淋巴细胞白血病的预后标志物：来自前瞻性、多中心II期CLL-009试验的数据

Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial

原文发布日期：2016-03-11

DOI: 10.1038/bcj.2016.9

类型: Original Article

开放获取: 是

英文摘要：

Efficacy of lenalidomide was investigated in 103 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated on the prospective, multicenter randomized phase-II CLL-009 trial. Interphase cytogenetic and mutational analyses identified TP53 mutations, unmutated IGHV, or del(17p) in 36/96 (37.5%), 68/88 (77.3%) or 22/92 (23.9%) patients. The overall response rate (ORR) was 40.4% (42/104). ORRs were similar irrespective of TP53 mutation (36.1% (13/36) vs 43.3% (26/60) for patients with vs without mutation) or IGHV mutation status (45.0% (9/20) vs 39.1% (27/68)); however, patients with del(17p) had lower ORRs than those without del(17p) (21.7% (5/22) vs 47.1% (33/70); P=0.049). No significant differences in progression-free survival and overall survival (OS) were observed when comparing subgroups defined by the presence or absence of high-risk genetic characteristics. In multivariate analyses, only multiple prior therapies (⩾3 lines) significantly impacted outcomes (median OS: 21.2 months vs not reached; P=0.019). This analysis indicates that lenalidomide is active in patients with relapsed/refractory CLL with unfavorable genetic profiles, including TP53 inactivation or unmutated IGHV. (ClinicalTrials.gov identifier: NCT00963105).

摘要翻译： 

来那度胺的疗效在一项前瞻性、多中心随机II期CLL-009试验中进行了研究，该试验纳入了103例复发/难治性慢性淋巴细胞白血病（CLL）患者。间期细胞遗传学和突变分析发现，36/96例（37.5%）患者存在TP53突变，68/88例（77.3%）为未突变IGHV，22/92例（23.9%）存在del(17p)。总缓解率（ORR）为40.4%（42/104）。无论TP53突变状态（有突变 vs 无突变：36.1%（13/36） vs 43.3%（26/60））或IGHV突变状态（45.0%（9/20） vs 39.1%（27/68）），ORR均相似；然而，del(17p)患者的ORR低于无del(17p)的患者（21.7%（5/22） vs 47.1%（33/70）；P=0.049）。按是否存在高危遗传特征定义的亚组进行比较时，无进展生存期和总生存期（OS）均未见显著差异。在多变量分析中，只有多次既往治疗（≥3线）显著影响结局（中位OS：21.2个月 vs 未达到；P=0.019）。该分析表明，来那度胺在具有不良遗传特征（包括TP53失活或未突变IGHV）的复发/难治性CLL患者中具有活性。（ClinicalTrials.gov标识符：NCT00963105）。

原文链接：

Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial