Division of Hematology-Oncology, University of Virginia Comprehensive Cancer Center, Translational Orphan Blood Cancer Research Center, University of Virginia, Charlottesville, VA.
Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Blood Adv. 2024 Jun 11;8(11):2601-2611. doi: 10.1182/bloodadvances.2023010441.
Patients with relapsed or refractory (R/R) mature natural killer cell and T-cell lymphoma have limited treatment options. To evaluate pralatrexate's performance and factors influencing its safety and efficacy in R/R peripheral T-cell lymphoma (PTCL), we performed a pooled analysis of data from 4 similarly designed, regulatory-mandated prospective clinical trials. Of 221 patients (median age, 59 years; 67.0% male) in the study population, 48.9% had PTCL not otherwise specified (PTCL-NOS), 21.3% angioimmunoblastic T-cell lymphoma, and 11.8% ALK-negative anaplastic large cell lymphoma (ALCL). Patients received pralatrexate for a median of 2.56 months (range, 0.03-24.18) and had a 40.7% objective response rate with a median duration of response of 9.1 months, progression-free survival 4.6 months, and overall survival 16.3 months. The most common treatment-related all-grade adverse events were stomatitis, thrombocytopenia, white blood cell count decrease, pyrexia, and vomiting. Subgroup exploratory analyses suggest improved efficacy with 1 prior line of chemotherapy vs 2 or ≥4 prior lines; PTCL-NOS or ALCL vs transformed mycosis fungoides; chemotherapy and transplant before pralatrexate vs chemotherapy alone or chemotherapy with other nontransplant treatments. In conclusion, these pooled analysis results further support using pralatrexate in patients with R/R PTCL. Prospective studies are needed to confirm the findings of subgroups analyses.
复发或难治性（R/R）成熟自然杀伤细胞和 T 细胞淋巴瘤患者的治疗选择有限。为了评估普拉曲沙在 R/R 外周 T 细胞淋巴瘤（PTCL）中的疗效和影响其安全性和疗效的因素，我们对 4 项类似设计、监管要求的前瞻性临床试验的数据进行了汇总分析。在研究人群的 221 例患者（中位年龄，59 岁；67.0%为男性）中，48.9%为未特指的 PTCL（PTCL-NOS），21.3%为血管免疫母细胞性 T 细胞淋巴瘤，11.8%为 ALK 阴性间变性大细胞淋巴瘤（ALCL）。患者接受普拉曲沙治疗的中位时间为 2.56 个月（范围，0.03-24.18），客观缓解率为 40.7%，中位缓解持续时间为 9.1 个月，无进展生存期为 4.6 个月，总生存期为 16.3 个月。最常见的治疗相关 3-4 级不良事件是口腔炎、血小板减少症、白细胞计数减少、发热和呕吐。亚组探索性分析表明，与 2 线或≥4 线化疗相比，1 线化疗的疗效更好；PTCL-NOS 或 ALCL 比转化性蕈样真菌病更好；普拉曲沙治疗前接受化疗和移植与单纯化疗或化疗加其他非移植治疗相比，疗效更好。总之，这些汇总分析结果进一步支持在 R/R PTCL 患者中使用普拉曲沙。需要前瞻性研究来证实亚组分析的结果。
