来那度胺治疗伊布替尼治疗后复发/进展或不耐受/难治的套细胞淋巴瘤患者的观察性研究（MCL-004）。
Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004).
机构信息
Department of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, USA.
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
出版信息
J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5.
BACKGROUND
The observational MCL-004 study evaluated outcomes in patients with relapsed/refractory mantle cell lymphoma who received lenalidomide-based therapy after ibrutinib failure or intolerance.
METHODS
The primary endpoint was investigator-assessed overall response rate based on the 2007 International Working Group criteria.
RESULTS
Of 58 enrolled patients (median age, 71 years; range, 50-89), 13 received lenalidomide monotherapy, 11 lenalidomide plus rituximab, and 34 lenalidomide plus other treatment. Most patients (88%) had received ≥ 3 prior therapies (median 4; range, 1-13). Median time from last dose of ibrutinib to the start of lenalidomide was 1.3 weeks (range, 0.1-21.7); 45% of patients had partial responses or better to prior ibrutinib. Primary reasons for ibrutinib discontinuation were lack of efficacy (88%) and ibrutinib toxicity (9%). After a median of two cycles (range, 0-11) of lenalidomide-based treatment, 17 patients responded (8 complete responses, 9 partial responses), for a 29% overall response rate (95% confidence interval, 18-43%) and a median duration of response of 20 weeks (95% confidence interval, 2.9 to not available). Overall response rate to lenalidomide-based therapy was similar for patients with relapsed/progressive disease after previous response to ibrutinib (i.e., ≥PR) versus ibrutinib-refractory (i.e., ≤SD) patients (30 versus 32%, respectively). The most common all-grade treatment-emergent adverse events after lenalidomide-containing therapy (n = 58) were fatigue (38%) and cough, dizziness, dyspnea, nausea, and peripheral edema (19% each). At data cutoff, 28 patients have died, primarily due to mantle cell lymphoma.
CONCLUSION
Lenalidomide-based treatment showed clinical activity, with no unexpected toxicities, in patients with relapsed/refractory mantle cell lymphoma who previously failed ibrutinib therapy.
TRIAL REGISTRATION
Clinicaltrials.gov identifier NCT02341781 . Date of registration: January 14, 2015.
背景
观察性 MCL-004 研究评估了伊布替尼失败或不耐受后接受来那度胺为基础的治疗的复发/难治性套细胞淋巴瘤患者的结局。
方法
主要终点是根据 2007 年国际工作组标准评估的研究者评估的总缓解率。
结果
在 58 名入组患者中（中位年龄 71 岁；范围 50-89 岁），13 名接受来那度胺单药治疗，11 名接受来那度胺联合利妥昔单抗治疗，34 名接受来那度胺联合其他治疗。大多数患者（88%）接受了≥3 种既往治疗（中位 4 种；范围 1-13 种）。从伊布替尼最后一剂到开始来那度胺的中位时间为 1.3 周（范围 0.1-21.7 周）；45%的患者对先前的伊布替尼有部分缓解或更好的反应。伊布替尼停药的主要原因是缺乏疗效（88%）和伊布替尼毒性（9%）。在接受来那度胺为基础的治疗中位 2 个周期（范围 0-11 个）后，17 名患者有缓解（8 名完全缓解，9 名部分缓解），总缓解率为 29%（95%置信区间，18-43%），缓解持续时间的中位数为 20 周（95%置信区间，2.9 至无）。先前对伊布替尼有反应（即≥PR）与伊布替尼耐药（即≤SD）的患者（分别为 30%和 32%），接受来那度胺为基础的治疗的总缓解率相似。接受含来那度胺治疗后最常见的所有级别治疗相关不良事件（n=58）为疲劳（38%）和咳嗽、头晕、呼吸困难、恶心和外周水肿（各 19%）。在数据截止时，28 名患者死亡，主要死于套细胞淋巴瘤。
结论
在先前伊布替尼治疗失败的复发/难治性套细胞淋巴瘤患者中，来那度胺为基础的治疗显示出临床活性，无意外毒性。
临床试验注册
Clinicaltrials.gov 标识符 NCT02341781。注册日期：2015 年 1 月 14 日。
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