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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.

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. European journal of cancer (Oxford, England : 1990) Kim, Y. H., Prince, H. M., Whittaker, S., Horwitz, S. M., Duvic, M., Bechter, O., Sanches, J. A., Stadler, R., Scarisbrick, J., Quaglino, P., Zinzani, P. L., Wolter, P., Eradat, H., Pinter-Brown, L. C., Ortiz-Romero, P. L., Akilov, O. E., Trotman, J., Taylor, K., Weichenthal, M., Walewski, J., Fisher, D., McNeeley, M., Gru, A. A., Brown, L., Palanca-Wessels, M. C., Lisano, J., Onsum, M., Bunn, V., Little, M., Trepicchio, W. L., Dummer, R. 2021; 148: 411–21

Abstract

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 CD30min<10% (=1 biopsy with <10% CD30 expression), or CD30min=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 CD30min<10% (40.9% versus 9.5%), with CD30min=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 CD30min<10% (16.7 versus 2.3 months), with CD30min=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.

View details for DOI 10.1016/j.ejca.2021.01.054

View details for PubMedID 33794441