Wen Xiaolian, Guan Tao, Yu Qinchuan, Wang Yanli, Wang Lieyang, Zheng Yuping, Han Wei'e, Su Liping
Cancer Hospital Affiliated to Shanxi Medical University/Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China.
Ann Hematol. 2024 Dec;103(12):5527-5537. doi: 10.1007/s00277-024-06063-6. Epub 2024 Oct 25.
Tucidinostat has been approved by the Chinese FDA for relapsed/refractory Peripheral T cell lymphoma (PTCL), but its efficacy in newly diagnosed PTCL has not been confirmed. In this study, we aimed to compare the efficacy of tucidinostat combined with CHOP-like (C + CHT) versus CHOP-like alone (CHT) in newly diagnosed PTCL patients. Of the PTCL patients, 109 were newly diagnosed. Patients in the C + CHT group who achieved objective response received tucidinostat maintenance therapy. A total of 36 pairs (n = 72) were matched at a ratio of 1:1 using propensity scoring. The matching criteria included: whether the Prognostic index for the peripheral T-cell lymphoma-not otherwise specified subtype (PIT) was ≥ 2, the pathological subtype, age > 60 years, and gender (matching tolerance = 0.024). A significantly higher objective response rate (ORR) (P = 0.016), 2-year progression-free survival (PFS) (P = 0.026), and 2-year survival rate (P = 0.017) was observed for the C + CHT group as compared to the CHT group. After propensity score matching (PSM), the C + CHT group as compared to the CHT group displayed significantly longer PFS (P = 0.035) and overall survival (OS) (P = 0.029). For the C + CHT group in the per-protocol set, the effect values showed a significant benefit in terms of both PFS (P = 0.027) and OS (P = 0.019). Common grade 3-4 haematological adverse events (AEs), had comparable incidence in each group; while common non-haematological AEs, including elevated AST and ALT were higher in the C + CHT group than in the CHT group. Our study suggests that the tucidinostat with CHOP-like regimen and sequential tucidinostat maintenance after objective remission provides a promising therapeutic approach for treating newly diagnosed PTCL patients.
图西诺司他已被中国食品药品监督管理局批准用于复发/难治性外周T细胞淋巴瘤(PTCL),但其在新诊断PTCL中的疗效尚未得到证实。在本研究中,我们旨在比较图西诺司他联合类CHOP方案(C + CHT)与单纯类CHOP方案(CHT)在新诊断PTCL患者中的疗效。在PTCL患者中,109例为新诊断患者。C + CHT组中达到客观缓解的患者接受图西诺司他维持治疗。使用倾向评分以1:1的比例共匹配了36对(n = 72)。匹配标准包括:外周T细胞淋巴瘤非特指亚型(PIT)的预后指数是否≥2、病理亚型、年龄>60岁以及性别(匹配容忍度 = 0.024)。与CHT组相比,C + CHT组观察到显著更高的客观缓解率(ORR)(P = 0.016)、2年无进展生存期(PFS)(P = 0.026)和2年生存率(P = 0.017)。倾向评分匹配(PSM)后,与CHT组相比,C + CHT组显示出显著更长的PFS(P = 0.035)和总生存期(OS)(P = 0.029)。对于符合方案集的C + CHT组,效应值在PFS(P = 0.027)和OS(P = 0.019)方面均显示出显著益处。常见的3-4级血液学不良事件(AE)在每组中的发生率相当;而常见的非血液学AE,包括AST和ALT升高,C + CHT组高于CHT组。我们的研究表明,图西诺司他联合类CHOP方案以及在客观缓解后序贯图西诺司他维持治疗为治疗新诊断的PTCL患者提供了一种有前景的治疗方法。