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dc.contributor.authorPrince, Miles-
dc.contributor.otherKim, Youn-
dc.contributor.otherHorwitz, Steven-
dc.contributor.otherDummer, Reinhard-
dc.contributor.otherScarisbrick, Julia-
dc.contributor.otherQuaglino, Pietro-
dc.contributor.otherZinzani, Pier Luigi-
dc.contributor.otherWolter, Pascal-
dc.contributor.otherSanches, Jose-
dc.contributor.otherOrtiz-Romero, Pablo-
dc.contributor.otherAkilov, Oleg-
dc.contributor.otherGeskin, Larisa-
dc.contributor.otherTrotman, Judith-
dc.contributor.otherTaylor, Kerry-
dc.contributor.otherDalle, Stephane-
dc.contributor.otherWeichenthal, Michael-
dc.contributor.otherWalewski, Jan-
dc.contributor.otherFisher, David-
dc.contributor.otherDréno, Brigitte-
dc.contributor.otherStadler, Rudolf-
dc.contributor.otherFeldman, Tatyana-
dc.contributor.otherKuzel, Timothy-
dc.contributor.otherWang, Yinghui-
dc.contributor.otherPalanca-Wessels, Maria Corinna-
dc.contributor.otherZagadailov, Erin-
dc.contributor.otherTrepicchio, William-
dc.contributor.otherZhang, Wenwen-
dc.contributor.otherLin, Hui-Min-
dc.contributor.otherLiu, Yi-
dc.contributor.otherHuebner, Dirk-
dc.contributor.otherLittle, Meredith-
dc.contributor.otherWhittaker, Sean-
dc.contributor.otherDuvic, Madeleine-
dc.contributor.otherALCANZA Study Group-
dc.identifier.citationLancet. 2017 Aug 5;390(10094):555-566en_US
dc.description.abstractBACKGROUND: 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.en_US
dc.subjectCutaneous T-Cell Lymphomasen_US
dc.subjectQuality of Lifeen_US
dc.subjectSystemic Therapiesen_US
dc.subjectBrentuximab Vedotinen_US
dc.subjectConventional Therapyen_US
dc.subjectCD30-Positive Cutaneous T-Cell Lymphomasen_US
dc.subjectEfficacy Analysesen_US
dc.subjectSafety Analysesen_US
dc.subjectInternational Studyen_US
dc.subjectCD30-Positive Mycosis Fungoidesen_US
dc.subjectPrimary Cutaneous Anaplastic Large-Cell Lymphomaen_US
dc.subjectOral Methotrexateen_US
dc.subjectOral Bexaroteneen_US
dc.subjectGlobal Responseen_US
dc.subjectDirector of Molecular Oncology and Cancer Immunology, Epworth HealthCare, Victoria, Australiaen_US
dc.titleBrentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleThe Lanceten_US
dc.description.affiliatesDivision of Cancer Medicine, Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, VIC, Australiaen_US
dc.description.affiliatesSir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australiaen_US
dc.description.affiliatesDepartment of Dermatology, Stanford University School of Medicine, Stanford, CA, USAen_US
dc.description.affiliatesStanford Cancer Institute, Stanford, CA, USAen_US
dc.description.affiliatesDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USAen_US
dc.description.affiliatesDepartment of Dermatology, University Hospital Zurich, Zurich, Switzerlanden_US
dc.description.affiliatesDepartment of Dermatology, University Hospital Birmingham, Birmingham, UKen_US
dc.description.affiliatesDepartment of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italyen_US
dc.description.affiliatesInstitute of Haematology, University of Bologna, Bologna, Italyen_US
dc.description.affiliatesDepartment of General Medical Oncology, University Hospitals Leuven, Leuven, Belgiumen_US
dc.description.affiliatesDepartment of Dermatology, University of São Paulo Medical School, São Paulo, Brazilen_US
dc.description.affiliatesDepartment of Dermatology, University Hospital 12 de Octubre, Institute i+12 Medical School, University Complutense, Madrid, Spainen_US
dc.description.affiliatesDepartment of Dermatology, University of Pittsburgh, Pittsburgh, PA, USAen_US
dc.description.affiliatesDepartment of Dermatology, Columbia University, New York, NY, USAen_US
dc.description.affiliatesDepartment of Haematology, Concord Repatriation General Hospital, University of Sydney, Concord, NSW, Australiaen_US
dc.description.affiliatesICON Cancer Care, South Brisbane, QLD, Australiaen_US
dc.description.affiliatesDepartment of Dermatology, Hospices Civils de Lyon, Claude Bernard Lyon 1 University, Lyon, Franceen_US
dc.description.affiliatesDepartment of Dermatology, University Hospital of Schleswig-Holstein, Kiel, Germanyen_US
dc.description.affiliatesMaria Sklodowska-Curie Institute and Oncology Centre, Warsaw, Polanden_US
dc.description.affiliatesDana-Farber Cancer Institute, Boston, MA, USAen_US
dc.description.affiliatesFaculty of Medicine, Nantes University, Nantes, Franceen_US
dc.description.affiliatesUniversity Clinic for Dermatology, Johannes Wesling Medical Centre, Minden, Germanyen_US
dc.description.affiliatesJohn Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ, USAen_US
dc.description.affiliatesDivision of Hematology/Oncology/Cell Therapy, Department of Medicine, Rush University, Chicago, IL, USAen_US
dc.description.affiliatesSt John's Institute of Dermatology, Guys and St Thomas NHS Foundation Trust, London, UKen_US
dc.description.affiliatesThe University of Texas MD Anderson Cancer Center, Houston, TX, USAen_US
dc.type.studyortrialMulticentre Studiesen_US
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