Abstract
IntroductionMycosis 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. MethodsBaseline 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). ResultsClinical 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. ConclusionThese 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 registrationClinicaltrials.gov, NCT01578499.
Highlights
Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections
Biopsies from the 100 patients with MF were reassessed for CD30 expression levels using the Ventana IUO assay; baseline biopsy CD30 expression ranged from 0.0%
When patients were categorised per baseline, CD30 expression level (CD30min < 10% and CD30min ! 10%), 43 patients (43.0%; 22 in the brentuximab vedotin arm and 21 in the PC arm) had !1 biopsy with
Summary
Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. 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. Diagnostic and clinical management of CTCL includes at least one skin biopsy assessed by expert dermatopathological evaluation, often utilising immunohistochemistry (IHC) staining. Both primary cutaneous anaplastic large cell lymphoma (pcALCL) and MF are characterised by expression of cell-surface CD30 antigen; pcALCL is characterised by a high level of CD30 expression (!75% of tumour cells) [4], whereas MF may express CD30 to a more variable degree (
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