Exploratory Analysis of Practical Predictive Indices for the Efficacy of Mogamulizumab in Patients With Aggressive Adult T-Cell Leukemia-Lymphoma

IF 3.3 4区 医学 Q2 HEMATOLOGY
Yutaka Shimazu, Kenta Murotani, Hiroki Kitabayashi, Yukihiro Nishio
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引用次数: 0

Abstract

An exploratory analysis of past clinical trials was conducted to propose a predictive scoring system for the efficacy of mogamulizumab, an anti-CC chemokine receptor 4 (CCR4) antibody, based on easily measurable parameters. Factors affecting progression-free survival (PFS) were investigated using data from three clinical trials (NCT00920790, NCT01626664, and NCT01173887) and one clinical study (UMIN000013294) conducted in patients with relapsed/refractory (R/R) or untreated CCR4-positive aggressive adult T-cell leukemia-lymphoma (ATL) receiving mogamulizumab treatment. Twelve routinely measured clinical parameters and three calculated indices—lymphocyte-to-neutrophil count ratio, platelet-to-lymphocyte count ratio, and lymphocyte-to-monocyte count ratio (LMR)—were selected as variables. Univariate Cox proportional hazards analysis identified albumin level, disease type, lactate dehydrogenase (LDH), monocyte count, neutrophil count, and LMR as relevant factors in R/R ATL patients treated with mogamulizumab monotherapy (p < 0.05). A predictive model constructed from multivariate analysis results stratified the monotherapy group (n = 69) into three subgroups, with scores of 0 (n = 5), 1 (n = 25), and 2 (n = 39), based on LDH (0 for < 265 and 1 for ≥ 265) and LMR (0 for ≥ 3.571 and 1 for < 3.571). Median PFS values were 0.57, 0.46, and 0.07 years for scores 0, 1, and 2, respectively (log-rank test: p = 0.005 for score 0 vs. 2; p < 0.001 for score 1 vs. 2). The simple model combining LDH and LMR may predict PFS in patients with R/R aggressive ATL receiving mogamulizumab treatment. Since LDH and LMR are easily measurable in clinical practice, this model could help predict mogamulizumab efficacy and guide treatment decisions in this patient population.

Trial Registration: Registration number: UMIN000049135. Date of registration: October 17, 2022

Abstract Image

莫加珠单抗治疗侵袭性成人t细胞白血病-淋巴瘤疗效实用预测指标的探索性分析
我们对以往的临床试验进行了探索性分析,提出了一种基于易于测量参数的抗cc趋化因子受体4 (CCR4)抗体mogamulizumab疗效预测评分系统。影响无进展生存期(PFS)的因素使用三项临床试验(NCT00920790、NCT01626664和NCT01173887)和一项临床研究(UMIN000013294)的数据进行研究,该研究在接受莫加单抗治疗的复发/难治性(R/R)或未经治疗的ccr4阳性侵袭性成人t细胞白血病淋巴瘤(ATL)患者中进行。选取12个常规临床参数和3个计算指标——淋巴细胞与中性粒细胞计数比、血小板与淋巴细胞计数比和淋巴细胞与单核细胞计数比(LMR)作为变量。单因素Cox比例风险分析发现白蛋白水平、疾病类型、乳酸脱氢酶(LDH)、单核细胞计数、中性粒细胞计数和LMR是接受莫加单抗单药治疗的R/R ATL患者的相关因素(p <;0.05)。基于多变量分析结果构建的预测模型将单药治疗组(n = 69)分为三个亚组,基于LDH评分为0 (n = 5)、1 (n = 25)和2 (n = 39)。≥265为1)和LMR(≥3.571为0,<为1;3.571)。评分0、1和2的中位PFS值分别为0.57、0.46和0.07年(log-rank检验:评分0 vs. 2的p = 0.005;p & lt;分数1比2为0.001)。结合LDH和LMR的简单模型可以预测接受mogamulizumab治疗的R/R侵袭性ATL患者的PFS。由于LDH和LMR在临床实践中很容易测量,因此该模型可以帮助预测mogamulizumab的疗效并指导该患者群体的治疗决策。试验报名:注册号:UMIN000049135。报名日期:2022年10月17日
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来源期刊
Hematological Oncology
Hematological Oncology 医学-血液学
CiteScore
4.20
自引率
6.10%
发文量
147
审稿时长
>12 weeks
期刊介绍: Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
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