西达本胺联合泼尼松、环磷酰胺和沙利度胺治疗复发或难治性外周 T 细胞淋巴瘤的多中心 II 期临床试验。
Chidamide plus prednisone, cyclophosphamide, and thalidomide for relapsed or refractory peripheral T-cell lymphoma: A multicenter phase II trial.
机构信息
Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China.
Key Laboratory of Hematology of Nanjing Medical University, Nanjing, Jiangsu 210029, China.
出版信息
Chin Med J (Engl). 2024 Jul 5;137(13):1576-1582. doi: 10.1097/CM9.0000000000002836. Epub 2023 Dec 10.
BACKGROUND
Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory-particularly for relapsed or refractory (R/R) patients. This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons.
METHODS
We conducted a multicenter phase II clinical trial in which we combined chidamide (30 mg twice weekly) with prednisone (20 mg daily after breakfast), cyclophosphamide (50 mg daily after lunch), and thalidomide (100 mg daily at bedtime) (the CPCT regimen) for a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. Forty-five patients were ultimately enrolled from August 2016 to April 2021 with respect to Chinese patients at nine centers. Our primary objective was to assess the overall response rate (ORR) after the treatment with CPCT.
RESULTS
Of the 45 enrolled patients, the optimal ORR and complete response (CR)/CR unconfirmed (CRu) were 71.1% (32/45) and 28.9% (13/45), respectively, and after a median follow-up period of 56 months, the median progression-free survival (PFS) and overall survival (OS) were 8.5 months and 17.2 months, respectively. The five-year PFS and OS rates were 21.2% (95% confidence interval [CI], 7.9-34.5%) and 43.8% (95% CI, 28.3-59.3%), respectively. The most common adverse event was neutropenia (20/45, 44.4%), but we observed no treatment-related death.
CONCLUSION
The all-oral CPCT regimen was an effective and safe regimen for R/R PTCL patients who could not tolerate standard chemotherapy for various reasons.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT02879526.
背景
尽管近年来外周 T 细胞淋巴瘤（PTCL）的治疗取得了进展，但对于因各种原因不能耐受标准化疗的复发或难治性（R/R）PTCL 患者，其缓解率和长期疗效仍不尽人意。本Ⅱ期临床试验旨在探索口服联合方案——沙利度胺（来那度胺）、环磷酰胺、泼尼松（CPT）在因各种原因不能耐受标准化疗的 R/R PTCL 患者中的疗效和安全性。
方法
本研究为多中心Ⅱ期临床试验，共纳入 45 例来自中国 9 家中心的患者，给予沙利度胺（来那度胺）30mg，每周 2 次；泼尼松（来那度胺）20mg，每日早餐后；环磷酰胺 50mg，每日午餐后；以及沙利度胺（来那度胺）100mg，每日睡前（CPT 方案），总疗程不超过 12 周期，为诱导-联合治疗期，随后应用沙利度胺（来那度胺）单药维持。主要研究终点为 CPCT 治疗后的总缓解率（ORR）。
结果
45 例患者中，最佳 ORR 和完全缓解（CR）/未确认的完全缓解（CRu）分别为 71.1%（32/45）和 28.9%（13/45），中位随访 56 个月后，中位无进展生存期（PFS）和总生存期（OS）分别为 8.5 个月和 17.2 个月，5 年 PFS 和 OS 率分别为 21.2%（95%CI，7.9-34.5%）和 43.8%（95%CI，28.3-59.3%）。最常见的不良反应是中性粒细胞减少（20/45，44.4%），但无治疗相关死亡。
结论
对于因各种原因不能耐受标准化疗的 R/R PTCL 患者，口服 CPT 方案是一种有效且安全的治疗方案。
试验注册
ClinicalTrials.gov，NCT02879526。
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