对 Brentuximab vedotin 与医师选择的回应：根据 CD30 表达和大细胞转化状态在蕈样肉芽肿患者中的比较：ALCANZA 子分析。
Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis.
机构信息
Dermatology and Medicine, Stanford University School of Medicine and Cancer Institute, 780 Welch Road, CJ220D, 94305, Stanford, CA, USA.
Department of Haematology, University of Melbourne, 140 Clarendon Street, 3002, East Melbourne, Australia.
出版信息
Eur J Cancer. 2021 May;148:411-421. doi: 10.1016/j.ejca.2021.01.054. Epub 2021 Mar 29.
INTRODUCTION
Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III ALCANZA study.
METHODS
Baseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using ≥2 skin biopsies obtained at screening; eligible patients required ≥1 biopsy with ≥10% CD30 expression. Patients were categorised as CD30 < 10% (≥1 biopsy with <10% CD30 expression), or CD30 ≥ 10% (all biopsies with ≥10% CD30 expression) and baseline LCT present or absent. Efficacy analyses were the proportion of patients with objective response lasting ≥4 months (ORR4) and progression-free survival (PFS).
RESULTS
Clinical activity with brentuximab vedotin was observed across all CD30 expression levels in patients with ≥1 biopsy showing ≥10% CD30 expression. Superior ORR4 was observed with brentuximab vedotin versus physician's choice in patients: with CD30 < 10% (40.9% versus 9.5%), with CD30 ≥ 10% (57.1% versus 10.3%), with LCT (64.7% versus 17.6%) and without LCT (38.7% versus 6.5%). Brentuximab vedotin improved median PFS versus physician's choice in patients: with CD30 < 10% (16.7 versus 2.3 months), with CD30 ≥ 10% (15.5 versus 3.9 months), with LCT (15.5 versus 2.8 months) and without LCT (16.1 versus 3.5 months). Safety profiles were generally comparable across subgroups.
CONCLUSION
These exploratory analyses demonstrated that brentuximab vedotin improved rates of ORR4 and PFS versus physician's choice in patients with CD30-positive MF and ≥1 biopsy showing ≥10% CD30 expression, regardless of LCT status.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov, NCT01578499.
简介
蕈样真菌病（MF），最常见的皮肤 T 细胞淋巴瘤类型，可导致毁容病变、衰弱性瘙痒和频繁的皮肤感染。本研究评估了 brentuximab vedotin 在 III 期 ALCANZA 研究中患有 MF 的患者中的反应。
方法
使用 ≥2 份筛查时获得的皮肤活检，对先前治疗的 CD30 阳性 MF 患者的基线 CD30 水平和大细胞转化（LCT）状态进行中心审查；合格的患者需要 ≥1 份活检，活检中 CD30 表达≥10%。根据基线时是否存在 LCT，将患者分为 CD30＜10%（≥1 份活检中 CD30 表达＜10%）和 CD30≥10%（所有活检中 CD30 表达≥10%）。疗效分析包括≥4 个月的客观缓解率（ORR4）和无进展生存期（PFS）。
结果
在所有≥1 份活检中 CD30 表达≥10%的患者中，brentuximab vedotin 均观察到临床活性。与医生选择相比，brentuximab vedotin 在以下患者中观察到更好的 ORR4：CD30＜10%（40.9% vs 9.5%），CD30≥10%（57.1% vs 10.3%），LCT（64.7% vs 17.6%）和无 LCT（38.7% vs 6.5%）。与医生选择相比，brentuximab vedotin 改善了患者的中位 PFS：CD30＜10%（16.7 个月 vs 2.3 个月），CD30≥10%（15.5 个月 vs 3.9 个月），LCT（15.5 个月 vs 2.8 个月）和无 LCT（16.1 个月 vs 3.5 个月）。安全性概况在各亚组中大致相当。
结论
这些探索性分析表明，与医生选择相比，brentuximab vedotin 提高了 CD30 阳性 MF 患者的 ORR4 和 PFS 率，无论 LCT 状态如何，患者均有≥1 份活检显示 CD30 表达≥10%。
临床试验注册
Clinicaltrials.gov，NCT01578499。
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