Department of Hematology, Institut Paoli-Calmettes, Marseille, France.
Department of Clinical Research and Innovation - Biostatistics & Methodology Unit, Marseille, France.
Hematology. 2023 Dec;28(1):2207948. doi: 10.1080/16078454.2023.2207948.
Relapsed/Refractory Diffuse Large B Cell Lymphoma have a dismal prognosis in need of innovative treatments. This prospective phase 2 study enrolled 32 patients between 2013 and 2017 with Relapsed/Refractory Diffuse Large B Cell Lymphoma treated with Rituximab and Lenalidomide (R2). Median age was 69 years (40-86), 90.1% had received at least 2 prior lines of treatment, 81% were defined as having High Risk disease according to our criteria and ECOG performance status was > 2 in 51.6%. Patients received a median number of 2 cycles of R2 (1-12). With a median follow up of 22.6 months, the objective response rate was 12.5%. Median progression free survival was 2.6 months (95% CI, [1.7-2.9]) and median overall survival was 9.3 months (95% CI, [5.1-Not estimable]). This study therefore did not achieve its primary endpoint and the R2 regimen cannot be recommended in Relapsed/Refractory Diffuse Large B Cell Lymphoma patients with High Risk features.
复发/难治性弥漫性大 B 细胞淋巴瘤患者预后极差，需要创新治疗。这项前瞻性 2 期研究于 2013 年至 2017 年期间纳入了 32 名复发/难治性弥漫性大 B 细胞淋巴瘤患者，他们接受了利妥昔单抗和来那度胺（R2）治疗。中位年龄为 69 岁（40-86 岁），90.1%的患者接受了至少 2 线治疗，81%根据我们的标准被定义为高危疾病，51.6%的患者 ECOG 表现状态为>2。患者接受了中位数为 2 个周期的 R2（1-12 个周期）。中位随访时间为 22.6 个月，客观缓解率为 12.5%。中位无进展生存期为 2.6 个月（95%CI，[1.7-2.9]），中位总生存期为 9.3 个月（95%CI，[5.1-不可估计]）。因此，该研究未达到其主要终点，R2 方案不能推荐用于具有高危特征的复发/难治性弥漫性大 B 细胞淋巴瘤患者。
