Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Department of Hematology and Oncology, Baylor College of Medicine, Houston, TX, USA.
Leuk Lymphoma. 2024 Sep;65(9):1325-1334. doi: 10.1080/10428194.2024.2349700. Epub 2024 May 15.
We report on the long-term efficacy and safety of a phase 2 trial of sequential cladribine and rituximab in hairy cell leukemia (HCL). One-hundred and thirty-nine patients were enrolled: 111 in the frontline setting, 18 in first relapse, and 10 with variant HCL (HCLv). A complete response (CR) was achieved in 133 of 137 evaluable participants (97%) with measurable residual disease (MRD) negativity in 102 (77%). MRD status was not associated with significant differences in event-free survival (EFS) or overall survival (OS). With a median follow-up of 7.8 years (range: 0.40-18.8), eight patients have experienced disease relapse (5.8%), 4/111 with newly diagnosed HCL (3·6%) and 4/10 with HCLv (40%) ( = 0.002). The 10-year EFS and OS rates were 86.7% and 91.1%, respectively. Grade 3 adverse events were observed in 28 participants (20·1%), mostly due to infections. Treatment of HCL with sequential cladribine followed by rituximab is associated with excellent efficacy and safety results both in the frontline and relapsed settings.
我们报告了一项 2 期临床试验的长期疗效和安全性，该试验在毛细胞白血病（HCL）中使用序贯克拉屈滨和利妥昔单抗。共纳入 139 例患者：111 例为一线治疗，18 例为首次复发，10 例为变异型 HCL（HCLv）。137 例可评估患者中有 133 例（97%）达到完全缓解（CR），其中 102 例（77%）的微小残留病（MRD）为阴性。MRD 状态与无事件生存（EFS）或总生存（OS）无显著差异。中位随访时间为 7.8 年（范围：0.40-18.8），8 例患者发生疾病复发（5.8%），111 例中有 4 例（3.6%）为新诊断的 HCL，10 例中有 4 例（40%）为 HCLv（P=0.002）。10 年 EFS 和 OS 率分别为 86.7%和 91.1%。28 例患者（20.1%）出现 3 级不良事件，主要与感染有关。在一线和复发治疗中，序贯克拉屈滨继以利妥昔单抗治疗 HCL 具有良好的疗效和安全性。
