外周T细胞淋巴瘤一线治疗中曲替诺司他与CHOP类药物与CHOP类药物的比较:一项单中心真实世界研究。

IF 3 3区 医学 Q2 HEMATOLOGY Annals of Hematology Pub Date : 2024-10-25 DOI:10.1007/s00277-024-06063-6
Xiaolian Wen, Tao Guan, Qinchuan Yu, Yanli Wang, Lieyang Wang, Yuping Zheng, Wei'e Han, Liping Su
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引用次数: 0

摘要

中国药监局已批准曲昔单抗用于治疗复发/难治性外周T细胞淋巴瘤(PTCL),但其对新诊断的PTCL的疗效尚未得到证实。在这项研究中,我们旨在比较图西诺司他联合CHOP类药物(C+CHT)与单用CHOP类药物(CHT)在新诊断的PTCL患者中的疗效。在PTCL患者中,有109人是新确诊的。C + CHT组中获得客观应答的患者接受了tucidinostat维持治疗。通过倾向评分法,共有36对患者(n = 72)按1:1的比例进行了配对。匹配标准包括:外周T细胞淋巴瘤-未另作说明亚型(PIT)的预后指数是否≥2、病理亚型、年龄是否大于60岁以及性别(匹配容差=0.024)。与CHT组相比,C + CHT组的客观反应率(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)明显更高。倾向得分匹配(PSM)后,C + CHT 组与 CHT 组相比,PFS(P = 0.035)和总生存期(OS)(P = 0.029)明显更长。在按方案治疗组中,C+CHT组的效应值显示其在PFS(P = 0.027)和OS(P = 0.019)方面均有明显获益。常见的 3-4 级血液学不良事件(AEs)在各组中的发生率相当;而常见的非血液学不良事件(包括 AST 和 ALT 升高)在 C + CHT 组中的发生率高于 CHT 组。我们的研究表明,曲昔司特联合CHOP类方案和客观缓解后的曲昔司特序贯维持治疗为治疗新诊断的PTCL患者提供了一种很有前景的治疗方法。
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Comparison of tucidinostat with CHOP-like versus CHOP-like in first-line treatment of peripheral T-cell lymphoma: a single-center real-world study.

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.

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来源期刊
Annals of Hematology
Annals of Hematology 医学-血液学
CiteScore
5.60
自引率
2.90%
发文量
304
审稿时长
2 months
期刊介绍: Annals of Hematology covers the whole spectrum of clinical and experimental hematology, hemostaseology, blood transfusion, and related aspects of medical oncology, including diagnosis and treatment of leukemias, lymphatic neoplasias and solid tumors, and transplantation of hematopoietic stem cells. Coverage includes general aspects of oncology, molecular biology and immunology as pertinent to problems of human blood disease. The journal is associated with the German Society for Hematology and Medical Oncology, and the Austrian Society for Hematology and Oncology.
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