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Title: Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial.
Epworth Authors: Prince, Miles
Other Authors: Kim, Youn
Horwitz, Steven
Dummer, Reinhard
Scarisbrick, Julia
Quaglino, Pietro
Zinzani, Pier Luigi
Wolter, Pascal
Sanches, Jose
Ortiz-Romero, Pablo
Akilov, Oleg
Geskin, Larisa
Trotman, Judith
Taylor, Kerry
Dalle, Stephane
Weichenthal, Michael
Walewski, Jan
Fisher, David
Dréno, Brigitte
Stadler, Rudolf
Feldman, Tatyana
Kuzel, Timothy
Wang, Yinghui
Palanca-Wessels, Maria Corinna
Zagadailov, Erin
Trepicchio, William
Zhang, Wenwen
Lin, Hui-Min
Liu, Yi
Huebner, Dirk
Little, Meredith
Whittaker, Sean
Duvic, Madeleine
ALCANZA Study Group
Keywords: Cutaneous T-Cell Lymphomas
Quality of Life
Systemic Therapies
Brentuximab Vedotin
Conventional Therapy
CD30-Positive Cutaneous T-Cell Lymphomas
Efficacy Analyses
Safety Analyses
International Study
CD30-Positive Mycosis Fungoides
Primary Cutaneous Anaplastic Large-Cell Lymphoma
Oral Methotrexate
Oral Bexarotene
Global Response
Director of Molecular Oncology and Cancer Immunology, Epworth HealthCare, Victoria, Australia
Issue Date: Aug-2017
Publisher: Elsevier
Citation: Lancet. 2017 Aug 5;390(10094):555-566
Abstract: BACKGROUND: Cutaneous T-cell lymphomas are rare, generally incurable, and associated with reduced quality of life. Present systemic therapies rarely provide reliable and durable responses. We aimed to assess efficacy and safety of brentuximab vedotin versus conventional therapy for previously treated patients with CD30-positive cutaneous T-cell lymphomas. METHODS: In this international, open-label, randomised, phase 3, multicentre trial, we enrolled adult patients with CD30-positive mycosis fungoides or primary cutaneous anaplastic large-cell lymphoma who had been previously treated. Patients were enrolled across 52 centres in 13 countries. Patients were randomly assigned (1:1) centrally by an interactive voice and web response system to receive intravenous brentuximab vedotin 1·8 mg/kg once every 3 weeks, for up to 16 3-week cycles, or physician's choice (oral methotrexate 5-50 mg once per week or oral bexarotene 300 mg/m2 once per day) for up to 48 weeks. The primary endpoint was the proportion of patients in the intention-to-treat population achieving an objective global response lasting at least 4 months per independent review facility. Safety analyses were done in all patients who received at least one dose of study drug. This trial was registered with, number NCT01578499. FINDINGS: Between Aug 13, 2012, and July 31, 2015, 131 patients were enrolled and randomly assigned to a group (66 to brentuximab vedotin and 65 to physician's choice), with 128 analysed in the intention-to-treat population (64 in each group). At a median follow-up of 22·9 months (95% CI 18·4-26·1), the proportion of patients achieving an objective global response lasting at least 4 months was 56·3% (36 of 64 patients) with brentuximab vedotin versus 12·5% (eight of 64) with physician's choice, resulting in a between-group difference of 43·8% (95% CI 29·1-58·4; p<0·0001). Grade 3-4 adverse events were reported in 27 (41%) of 66 patients in the brentuximab vedotin group and 29 (47%) of 62 patients in the physician's choice group. Peripheral neuropathy was seen in 44 (67%) of 66 patients in the brentuximab vedotin group (n=21 grade 2, n=6 grade 3) and four (6%) of 62 patients in the physician's choice group. One of the four on-treatment deaths was deemed by the investigator to be treatment-related in the brentuximab vedotin group; no on-treatment deaths were reported in the physician's choice group. INTERPRETATION: Significant improvement in objective response lasting at least 4 months was seen with brentuximab vedotin versus physician's choice of methotrexate or bexarotene. FUNDING: Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd), Seattle Genetics Inc.
DOI: 10.1016/S0140-6736(17)31266-7
PubMed URL:
ISSN: 0140-6736
Journal Title: The Lancet
Type: Journal Article
Affiliated Organisations: Division of Cancer Medicine, Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, VIC, Australia
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia
Department of Dermatology, Stanford University School of Medicine, Stanford, CA, USA
Stanford Cancer Institute, Stanford, CA, USA
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
Department of Dermatology, University Hospital Birmingham, Birmingham, UK
Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy
Institute of Haematology, University of Bologna, Bologna, Italy
Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium
Department of Dermatology, University of São Paulo Medical School, São Paulo, Brazil
Department of Dermatology, University Hospital 12 de Octubre, Institute i+12 Medical School, University Complutense, Madrid, Spain
Department of Dermatology, University of Pittsburgh, Pittsburgh, PA, USA
Department of Dermatology, Columbia University, New York, NY, USA
Department of Haematology, Concord Repatriation General Hospital, University of Sydney, Concord, NSW, Australia
ICON Cancer Care, South Brisbane, QLD, Australia
Department of Dermatology, Hospices Civils de Lyon, Claude Bernard Lyon 1 University, Lyon, France
Department of Dermatology, University Hospital of Schleswig-Holstein, Kiel, Germany
Maria Sklodowska-Curie Institute and Oncology Centre, Warsaw, Poland
Dana-Farber Cancer Institute, Boston, MA, USA
Faculty of Medicine, Nantes University, Nantes, France
University Clinic for Dermatology, Johannes Wesling Medical Centre, Minden, Germany
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ, USA
Division of Hematology/Oncology/Cell Therapy, Department of Medicine, Rush University, Chicago, IL, USA
St John's Institute of Dermatology, Guys and St Thomas NHS Foundation Trust, London, UK
The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Type of Clinical Study or Trial: Multicentre Studies
Appears in Collections:Cancer Services

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