BACKGROUND & AIMS:
:Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of non-Hodgkin's lymphomas with poor clinical outcomes. Pralatrexate showed efficacy and safety in recurrent or refractory PTCLs. The purpose or this study was to investigate the efficacy and safety of pralatrexate in relapsed or refractory PTCLs in real-world practice. This was an observational, multicenter, retrospective analysis. Between December 2012 and December 2016, a total of 38 patients with relapsed or refractory PTCLs were treated with pralatrexate at 10 tertiary hospitals in Korea. Patients received an intravenous infusion of pralatrexate at a dose of 30 mg/m2/week for 6 weeks on a 7-week schedule. Modified dosing and/or scheduling was allowed according to institutional protocols. Median patient age was 58 years (range, 29-80 years) and the most common subtype was peripheral T-cell lymphoma, not otherwise specified (n = 23, 60.5%). The median dosage of pralatrexate per administration was 25.6 mg/m2/wk (range, 15.0-33.0 mg/m2/wk). In intention-to-treat analysis, 3 patients (7.9%) showed a complete response and 5 patients (13.2%) showed a partial response, resulting in an overall response rate (ORR) of 21.1%. The median duration of response was 7.6 months (range, 1.6-24.3 months). The median progression-free survival (PFS) was 1.8 months (95% confidence interval [CI], 1.7-1.8 months) and the median overall survival was 7.7 months (95% CI, 4.4-9.0 months). The most common grade 3/4 adverse events were thrombocytopenia (n = 13, 34.2%), neutropenia (n = 7, 23.7%), and anemia (n = 7, 18.4%). Our study showed relatively lower ORR and shorter PFS in patients with recurrent or refractory PTCLs treated with pralatrexate in real-world practice. The toxicity profile was acceptable and manageable. We also observed significantly lower dose intensity of pralatrexate in real-world practice.
背景与目标:
: 外周T细胞淋巴瘤 (PTCL) 是一组非霍奇金淋巴瘤,临床预后较差。Pralatrexate在复发性或难治性ptcl中显示出有效性和安全性。本研究的目的或本研究是在现实世界中研究普拉曲沙酯在复发或难治性ptcl中的疗效和安全性。这是一项观察性,多中心,回顾性分析。在2012年12月和2016年12月之间,共有38例复发或难治性ptcl患者在韩国的10家三级医院接受了pralatrexate治疗。患者在7周的时间表中接受30 mg/m2/周的pralatrexate的静脉输注,持续6周。根据机构协议,允许修改剂量和/或计划。中位患者年龄为58岁 (范围,29-80岁),最常见的亚型是外周T细胞淋巴瘤,未明确说明 (n = 23,60.5%)。Pratrexate每次给药的中位剂量为25.6 mg/m2/wk (范围为15.0-33.0 mg/m2/wk)。在意向治疗分析中,3例患者 (7.9%) 显示完全缓解,5例患者 (13.2%) 显示部分缓解,总缓解率 (ORR) 为21.1%。中位缓解持续时间为7.6个月 (范围,1.6-24.3个月)。中位无进展生存期 (PFS) 为1.8个月 (95% 置信区间 [CI],1.7-1.8个月),中位总生存期为7.7个月 (95% CI,4.4-9.0个月)。最常见的3/4级不良事件是血小板减少症 (n = 13,34.2%) 、中性粒细胞减少症 (n = 7,23.7%) 和贫血 (n = 7,18.4%)。我们的研究表明,在现实世界中,使用普拉雷酯治疗的复发性或难治性ptcl患者的ORR相对较低,PFS较短。毒性特征是可接受且可控制的。我们还观察到在现实世界中pralatrexate的剂量强度明显降低。