Witzig Thomas E, Luigi Zinzani Pier, Habermann Thomas M, Tuscano Joseph M, Drach Johannes, Ramchandren Radhakrishnan, Kalayoglu Besisik Sevgi, Takeshita Kenichi, Casadebaig Bravo Marie-Laure, Zhang Lei, Fu Tommy, Goy Andre
Mayo Clinic, Rochester, Minnesota.
Institute of Hematology Seràgnoli, University of Bologna, Bologna, Italy.
Am J Hematol. 2017 Oct;92(10):E575-E583. doi: 10.1002/ajh.24854. Epub 2017 Aug 28.
Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1 to 21 every 28-days) had a median age of 67 years (63% ≥65 years), 91% with stage III/IV disease, and 50% with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate (ORR) was 33% (including 11% with complete remission [CR]/CR unconfirmed CRu). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response (DOR) of 16.6 months (95% CI: 11.1%-29.8%). The safety profile was consistent and manageable; myelosuppression was the most common adverse event (AE). Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.
套细胞淋巴瘤（MCL）是一种非霍奇金淋巴瘤（NHL），具有侵袭性疾病特征，初始治疗后易多次复发。来那度胺是一种免疫调节剂，根据3项多中心II期研究（2项包括复发/难治性侵袭性NHL，1项聚焦硼替佐米治疗后的MCL）的结果，在美国被批准用于硼替佐米治疗后复发/难治性MCL患者。本报告的目的是提供MCL - 001研究的更长随访时间（随访时间分别为6.8个月[NHL - 002]、7.6个月[NHL - 003]和52.2个月[MCL - 001]）。206例复发MCL患者接受单药来那度胺治疗（口服25mg/天，第1至21天，每28天为一周期），中位年龄67岁（63%≥65岁），91%为III/IV期疾病，50%既往接受过≥4种治疗方案。中位随访X个月时，综合最佳总缓解率（ORR）为33%（包括11%完全缓解[CR]/未确认的完全缓解[CRu]）。来那度胺产生快速且持久的反应，中位反应时间为2.2个月，中位缓解持续时间（DOR）为16.6个月（95%CI：11.1% - 29.8%）。安全性特征一致且可控；骨髓抑制是最常见的不良事件（AE）。总体而言，单药来那度胺在多项II期研究中对复发/难治性MCL重度预处理患者，包括既往接受过硼替佐米治疗的患者，显示出一致的疗效和安全性。
