Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance)
Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance)
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DOI：
10.1182/bloodadvances.2017015396
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发表时间：
2018-07-24
期刊：
影响因子：
7.5
通讯作者：
Larson, Richard A.
中科院分区：
文献类型：
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作者：
Byrd, John C.;Ruppert, Amy S.;Larson, Richard A.
在针对慢性淋巴细胞白血病 (CLL) 的新型靶向药物出现之前，非 del(11q) 疾病患者的最佳化学免疫治疗方案尚不清楚。来那度胺的作用也没有明确。这项 2 期研究将 342 名未经治疗的非 del(11q) CLL 患者随机分配至氟达拉滨加利妥昔单抗 (FR；n=123)、FR 加来那度胺巩固治疗 (FR+L；n=109) 或 FR 加环磷酰胺 (FCR；n=110)，并将每种治疗的 2 年无进展生存率 (PFS) 与 FC 的历史对照率 (60%) 进行比较。至少 20% 预处理细胞中存在 del(11q) 的患者继续使用 FCR (n=27) 或重新分配至 FCR+L (n=31) 并从主要分析中排除。在非 del(11q) 患者中，2 年 PFS 率为 64%（90% 置信区间 [CI]，57-71；FR）、72%（90% CI，65-79；FR+L）和 74%（90% CI，66-80；FCR）； FR+L 和 FCR 的发生率显着高于历史对照。与 FR+L (P=.04) 和 FCR (P
Prior to novel targeted agents for chronic lymphocytic leukemia (CLL), the best chemoimmunotherapy regimen in patients with non-del(11q) disease was unclear. The role of lenalidomide was also not defined. This phase 2 study randomized 342 untreated patients with non-del(11q) CLL requiring therapy to fludarabine plus rituximab (FR; n=123), FR plus lenalidomide consolidation (FR+L; n=109), or FR plus cyclophosphamide (FCR; n=110) and compared 2-year progression-free survival (PFS) rates of each to the historical control rate with FC (60%). Patients with del(11q) in at least 20% of pretreatment cells continued with FCR (n=27) or were reassigned to FCR+L (n=31) and excluded from the primary analysis. Among non-del(11q) patients, 2-year PFS rates were 64% (90% confidence interval [CI], 57-71; FR), 72% (90% CI, 65-79; FR+L), and 74% (90% CI, 66-80; FCR); FR+L and FCR had rates significantly greater than historical control. Median PFS was significantly shorter with FR compared with FR+L (P=.04) and FCR (P