九年前瞻性随访分析Lenalidomide与Rituximab联合治疗作为患者原发性曼托细胞淋巴瘤的初始治疗。
Nine-year Follow-up of Lenalidomide Plus Rituximab as Initial Treatment for Mantle Cell Lymphoma.
发表日期:2023 Sep 08
作者:
Samuel Yamshon, Gui Chen, Caitlin Gribbin, Paul Christos, Bijal D Shah, Stephen J Schuster, Sonali M Smith, Jakub Svoboda, Richard R Furman, John P Leonard, Peter Martin, Jia Ruan
来源:
Blood Advances
摘要:
尽管化疗免疫治疗是曼特尔细胞淋巴瘤(MCL)初始治疗的标准,但新的数据表明,无化疗的方法可能有一定作用。我们报告了一项多中心2期研究关于来那度胺联合利妥昔单抗(LR)作为MCL初始治疗的9年随访结果。LR双联疗法用作诱导和维持治疗,直至疾病进展,3年后可选择停药。我们先前报告了可评估患者中的总体缓解率为92%,其中64%达到完全缓解。在中位随访时间为103个月的情况下,36名可评估患者中有17人(47%)仍处于缓解状态。9年无进展生存率(PFS)和总生存率(OS)分别为51%和66%。在维持期间,造血系统不良事件(AEs)包括无症状的3级或4级细胞减少症(42%的中性粒细胞减少症,5%的血小板减少症,3%的贫血症)以及主要为1级至2级感染,可在门诊进行管理(50%上呼吸道感染,21%尿路感染,16%鼻窦炎,16%蜂窝织炎,13%肺炎,其中5%需要住院)。维持治疗期间,较多患者出现1级和2级神经病变(29%),而诱导治疗期间的比例为8%。21%的患者发生了继发性恶性肿瘤,其中5%为侵袭性恶性肿瘤,其余为非侵袭性皮肤癌,采用局部皮肤定向治疗。由于对COVID-19大流行期间免疫抑制的担忧,两名患者永久停止了治疗。随着长期随访,LR作为初始诱导治疗继续显示出持久的缓解反应,并且具有可控的安全性。版权所有 © 2023 美国血液学会。
While chemoimmunotherapy is the current standard of care for initial treatment of mantle cell lymphoma (MCL), newer data suggests that there may be a role for a chemotherapy-free approach. We report 9-year follow up of a multi-center phase 2 study of lenalidomide plus rituximab (LR) as initial treatment of MCL. The LR doublet is used as induction and maintenance until progression, with optional discontinuation after 3 years. We previously reported an overall response rate in evaluable patients of 92%, with 64% achieving a complete response. At a median follow up of 103 months, 17 (47%) of 36 evaluable patients remain in remission. The 9-year progression-free survival (PFS) and overall survival (OS) were 51% and 66%, respectively. During maintenance, hematologic adverse events (AEs) included asymptomatic grade 3 or 4 cytopenia (42% neutropenia, 5% thrombocytopenia, 3% anemia) and mostly grade 1 to 2 infections managed in the outpatient setting (50% upper respiratory infections, 21% urinary tract infections, 16% sinusitis, 16% cellulitis, 13% pneumonia, with 5% requiring hospitalization). More patients developed grade 1 and 2 neuropathy during maintenance therapy (29%) than during induction therapy (8%). Twenty-one percent of patients developed secondary malignancies including 5% with invasive malignancies, while the remainder were non-invasive skin cancers treated with local skin-directed therapy. Two patients permanently discontinued therapy due to concerns for immunosuppression during the COVID-19 pandemic. With long-term follow up, LR continues to demonstrate prolonged, durable responses with manageable safety as initial induction therapy.Copyright © 2023 American Society of Hematology.