来那度胺联合利妥昔单抗治疗复发难治B细胞非霍奇金淋巴瘤效果观察  

Efficacy observation of lenalidomide and rituximab in treatment of relapsed/refractory B-cell non-Hodgkin lymphoma

作　　者：赵丹青[1] 冯俊[2] 蔡华聪[2] 曹欣欣[2] 李剑[2] 段明辉[2] 周道斌[2] 陈苗[2] 庄俊玲[2] 张炎[2] 杨辰[2] 张薇[2] Zhao Danqing;Feng Jun;Cai Huacong;Cao Xinxin;Li Jian;Duan Minghui;Zhou Daobin;Chen Miao;Zhuang Junling;Zhang Yan;Yang Chen;Zhang Wei(Department of Internal Medicine,Peking Union Medical College Hospital,Beijing 100730,China;Department of Hematology,Peking Union Medical College Hospital,Beijing 100730,China)

机构地区：[1]北京协和医院内科,100730 [2]北京协和医院血液科,100730

出　　处：《白血病．淋巴瘤》2019年第6期321-326,共6页Journal of Leukemia & Lymphoma

摘　　要：目的评估来那度胺联合利妥昔单抗(R2方案)治疗复发难治B细胞非霍奇金淋巴瘤(B-NHL)的效果和安全性.方法回顾性分析2015年1月至2017年12月于北京协和医院经多种方案治疗后复发难治B-NHL成年患者资料.患者接受R2方案治疗:来那度胺25 mg/d口服,第1天至第21天,同时在第1天予利妥昔单抗375 mg/m2静脉滴注,每28 d为1个疗程,每3个疗程后重新评估疗效;获得完全缓解(CR)、部分缓解(PR)、疾病稳定(SD)的患者继续R2方案治疗,拟完成8个疗程治疗.主要研究终点为总有效率(ORR)(以CR+PR计算),次要研究终点为1年无进展生存(PFS)率、1年总生存(OS)率及3~4级不良反应.测量7例患者基线状态下T、B细胞亚群情况,动态观察13例治疗有效患者的T、B细胞亚群.结果共纳入49例患者,之前经过1~4种方案化疗.患者R2方案治疗3个疗程后ORR为65%(32/49). 36例(73%)患者(CR 9例、PR 22例、SD 5例)进入R2方案维持治疗.中位随访时间13个月,1年PFS率为61%,1年OS率为84%.最常见的不良事件是骨髓抑制,其中3~4级中性粒细胞减少13例(27%),3~4级血小板减少3例(6%),4级贫血2例(4%),不良反应大部分可通过延长治疗间隔时间或减少来那度胺剂量得以控制.动态观察的13例治疗有效患者T、B细胞亚群指标中,仅显示治疗后CD19+ B细胞数下降(P<0.05).结论来那度胺联合利妥昔单抗治疗复发难治B-NHL具有较高反应性,患者耐受性良好.Objective To evaluate the safety and efficacy of lenalidomide plus rituximab in treatment of the patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Methods The clinical data of the patients with relapsed/refractory B-NHL after the varieties of treatment methods in Peking Union Medical College Hospital between January 2015 and December 2017 were retrospectively analyzed. All the patients were treated with R2 regimen: oral lenalidomide (25 mg/d for day 1-day 21) and rituximab (375 mg/m2 of intravenous infusion on day 1, 28-day of each cycle);the efficacy was evaluated after three cycles. After this induction phase, the patients achieving complete response (CR), partial response (PR), or stable disease (SD) were given R2 regimen until the end of 8 cycles. The major end point was overall response rate (ORR) defined as CR + PR. Secondary end point included 1-year progression free survival (PFS), 1-year overall survival (OS) and grade 3-4 adverse events. T cell and B cell subsets of 7 patients at baseline were measured, and T cell and B cell subsets of 13 patients with good efficacy were dynamically observed. Results A total of 49 patients who received 1-4 chemotherapy regimens were included. The ORR after the R2 treatment for 3 courses was 65%(32/49). Thirty-six patients (9 cases of CR, 22 cases of PR, 5 cases of SD) were enrolled in R2 maintenance treatment. The median follow-up time was 13 months, 1-year PFS rate was 61% and 1-year OS rate was 84%. The most common adverse event was bone marrow suppression, including grade 3-4 neutropenia (27%), grade 3-4 thrombocytopenia (6%) and grade 4 anemia (4%), most of which could be controlled by prolonging interval cycles or reduced lenalidomide dosage. The decreased number of CD19+B cell after treatment could be seen in 13 patients who obtained good efficacy under the dynamic observation. Conclusion Lenalidomide plus rituximab is well tolerated and highly active in the treatment of relapsed/refractory B-NHL.

关 键 词：淋巴瘤 B细胞 来那度胺 利妥昔单抗 难治 复发 预后 

分 类 号：R733.1[医药卫生—肿瘤]