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在复发性/难治性滤泡性淋巴瘤中使用 Tazemetostat:E7438-G000-101 试验结果的倾向评分匹配分析。

Tazemetostat in relapsed/refractory follicular lymphoma: a propensity score-matched analysis of E7438-G000-101 trial outcomes.

机构信息

Analysis Group, Inc., Menlo Park, CA 94025, USA.

Epizyme, Inc., Cambridge, MA 02139, USA.

出版信息

Oncotarget. 2022 May 11;13:677-683. doi: 10.18632/oncotarget.28229. eCollection 2022.

Abstract

PURPOSE

In the tazemetostat E7438-G000-101 trial of relapsed/refractory (R/R) follicular lymphoma (FL), apparent superior efficacy was suggested for mutant-type (MT) versus wild-type (WT) status. However, clinical disparities might have contributed to this conclusion. This study aimed to estimate outcomes after minimizing differences in baseline characteristics.

METHODS

Propensity scores for each participant with WT ( = 54) and MT ( = 45) status were generated based on the likelihood of being selected given their baseline characteristics. Participants were matched using a 1:1 nearest-neighbor approach.

RESULTS

The propensity-matched sample included 56 participants (28 WT, 28 MT). Objective response rates (95% confidence interval [CI]) were 35% (22-48) in WT and 69% (55-83) in MT prior to matching and 50% (31-69) in WT and 71% (54-88) in MT after matching. Median progression-free survival values (95% CI) were 11.1 (5.4-16.7) in WT and 13.8 months (11.1-22.1) in MT prior to matching and 14.3 (11.1-∞]) and 14.8 months (10.7-∞]) in WT and MT matched groups, respectively.

CONCLUSIONS

This analysis suggests that efficacy outcomes for tazemetostat observed in participants with WT R/R FL may have been similar to those in participants with MT had the 2 cohorts been more closely matched.

摘要

目的

在复发/难治性(R/R)滤泡性淋巴瘤(FL)的 tazemetostat E7438-G000-101 试验中,突变型(MT)与野生型(WT)状态相比,疗效明显提高。然而,临床差异可能导致了这一结论。本研究旨在通过最小化基线特征差异来估计结果。

方法

根据参与者的基线特征,对每个 WT(=54)和 MT(=45)状态的参与者生成倾向评分。使用 1:1 最近邻匹配方法对参与者进行匹配。

结果

匹配倾向评分后的样本包括 56 名参与者(WT 28 名,MT 28 名)。WT 组的客观缓解率(95%置信区间[CI])为 35%(22-48),MT 组为 69%(55-83),匹配前为 50%(31-69),MT 组为 71%(54-88),匹配后为 50%(31-69)。WT 组和 MT 组的中位无进展生存期值(95%CI)分别为 11.1(5.4-16.7)和 13.8 个月(11.1-22.1),匹配前分别为 14.3(11.1-∞])和 14.8 个月(10.7-∞])。

结论

这项分析表明,在 WT R/R FL 患者中观察到的 tazemetostat 疗效结果可能与 MT 患者相似,如果这两组患者匹配更紧密的话。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cae7/9093865/5f7ce32558c4/oncotarget-13-28229-g001.jpg

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