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

作者：Youn H. Kim, H. Miles Prince, Sean Whittaker, Sarah McCue Horwitz, Madeleine Duvic, Oliver Bechter, José Antônio Sanches, Rudolf Stadler, Julia Scarisbrick, Pietro Quaglino, Pier Luigi Zinzani, Pascal Wolter, Herbert Eradat, Lauren Pinter‐Brown, Pablo L. Ortiz‐Romero, Oleg E. Akilov, Judith Trotman, Kerry Taylor, Michael Weichenthal, Jan Walewski, David C. Fisher, Marise McNeeley, Alejandro A. Gru, Lisa Brown, Maria Corinna Palanca-Wessels, Julie Lisano, Matthew Onsum, Veronica Bunn, Meredith Little, William L. Trepicchio, Reinhard Dummer · 发表于：European Journal of Cancer · 年份：2021 · DOI：10.1016/j.ejca.2021.01.054 · 被引用次数：59 · 研究领域：Cutaneous lymphoproliferative disorders research、Lymphoma Diagnosis and Treatment、Lymphatic System and Diseases

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 min < 10% (≥1 biopsy with <10% CD30 expression), or CD30 min ≥ 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 min < 10% (40.9% versus 9.5%), with CD30 min ≥ 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 min < 10% (16.7 versus 2.3 months), with CD30 min ≥ 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 ...