皮下注射利妥昔单抗- MiniCHOP 与皮下注射利妥昔单抗- MiniCHOP 联合来那度胺治疗 80 岁及以上弥漫性大 B 细胞淋巴瘤患者的比较。

Subcutaneous Rituximab-MiniCHOP Compared With Subcutaneous Rituximab-MiniCHOP Plus Lenalidomide in Diffuse Large B-Cell Lymphoma for Patients Age 80 Years or Older.

机构信息

Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse, France.

Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.

出版信息

J Clin Oncol. 2021 Apr 10;39(11):1203-1213. doi: 10.1200/JCO.20.02666. Epub 2021 Jan 14.

DOI:10.1200/JCO.20.02666

PMID:33444079

Abstract

PURPOSE

The prognosis of elderly patients with diffuse large B-cell lymphoma (DLBCL) is worse than that of young patients. An attenuated dose of chemotherapy-cyclophosphamide, doxorubicin, vincristine, and prednisone plus rituximab (R-miniCHOP)-is a good compromise between efficacy and safety in very elderly patients. In combination with R-CHOP (R2-CHOP), lenalidomide has an acceptable level of toxicity and may mitigate the negative prognosis of the non-germinal center B-cell-like phenotype. The Lymphoma Study association conducted a multicentric, phase III, open-label, randomized trial to compare R-miniCHOP and R2-miniCHOP.

PATIENTS AND METHODS

Patients of age 80 years or older with untreated DLBCL were randomly assigned into the R-miniCHOP21 group or the R2-miniCHOP21 group for six cycles and stratified according to CD10 expression and age. The first cycle of rituximab was delivered by IV on D1 after a prephase and then delivered subcutaneously on D1 of cycles 2-6. Lenalidomide was delivered at a dose of 10 mg once daily on D1-D14 of each cycle. The primary end point was overall survival (OS).

RESULTS

A total of 249 patients with new DLBCL were randomly assigned (127 R-miniCHOP and 122 R2-miniCHOP). The median age was 83 years (range, 80-96), and 55% of the patients were classified as non-GCB. The delivered dose for each R-miniCHOP compound was similar in both arms. Over a median follow-up of 25.1 months, the intention-to-treat analysis revealed that R2-miniCHOP did not improve OS (2-year OS 66% in R-miniCHOP and 65.7% in R2-miniCHOP arm, = .98) in the overall population or in the non-GCB population. Grade 3-4 adverse events occurred in 53% of patients with R-miniCHOP and in 81% of patients with R2-miniCHOP.

CONCLUSION

The addition of lenalidomide to R-miniCHOP does not improve OS. Rituximab delivered subcutaneously was safe in this population.

摘要

目的

老年弥漫性大 B 细胞淋巴瘤（DLBCL）患者的预后较年轻患者差。在非常高龄的患者中，环磷酰胺、多柔比星、长春新碱和泼尼松联合利妥昔单抗（R-miniCHOP）的低剂量化疗是在疗效和安全性之间的良好折衷。与 R-CHOP（R2-CHOP）联合使用时，来那度胺具有可接受的毒性水平，并且可能减轻非生发中心 B 细胞样表型的不良预后。淋巴瘤研究协会进行了一项多中心、III 期、开放性、随机试验，以比较 R-miniCHOP 和 R2-miniCHOP。

患者和方法

未经治疗的 DLBCL 且年龄在 80 岁或以上的患者被随机分配到 R-miniCHOP21 组或 R2-miniCHOP21 组，进行 6 个周期，并根据 CD10 表达和年龄进行分层。第 1 个周期的利妥昔单抗在预治疗后第 1 天通过 IV 给药，然后在第 2-6 个周期的第 1 天皮下给药。来那度胺的剂量为 10mg，每日 1 次，在每个周期的第 1-14 天给药。主要终点是总生存期（OS）。

结果

共有 249 例新诊断的 DLBCL 患者被随机分配（R-miniCHOP127 例，R2-miniCHOP122 例）。中位年龄为 83 岁（范围为 80-96 岁），55%的患者为非 GCB 型。两个治疗组中每个 R-miniCHOP 化合物的给药剂量相似。在中位随访 25.1 个月后，意向治疗分析显示，R2-miniCHOP 并未改善总人群（R-miniCHOP 组 2 年 OS 为 66%，R2-miniCHOP 组为 65.7%， =.98）或非 GCB 人群的 OS。R-miniCHOP 组有 53%的患者发生 3-4 级不良事件，而 R2-miniCHOP 组有 81%的患者发生。