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Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial
S. Horwitz, OA. O'Connor, B. Pro, T. Illidge, M. Fanale, R. Advani, NL. Bartlett, JH. Christensen, F. Morschhauser, E. Domingo-Domenech, G. Rossi, WS. Kim, T. Feldman, A. Lennard, D. Belada, Á. Illés, K. Tobinai, K. Tsukasaki, SP. Yeh, A....
Language English Country England, Great Britain
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1992-01-04 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Health & Medicine (ProQuest)
from 1992-01-04 to 3 months ago
Family Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Psychology Database (ProQuest)
from 1992-01-04 to 3 months ago
Health Management Database (ProQuest)
from 1992-01-04 to 3 months ago
Public Health Database (ProQuest)
from 1992-01-04 to 3 months ago
- MeSH
- Intention to Treat Analysis MeSH
- Lymphoma, Large-Cell, Anaplastic drug therapy MeSH
- Cyclophosphamide administration & dosage MeSH
- Adult MeSH
- Doxorubicin administration & dosage MeSH
- Double-Blind Method MeSH
- Immunoconjugates administration & dosage adverse effects MeSH
- Immunologic Factors administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Prednisone administration & dosage MeSH
- Disease-Free Survival MeSH
- Antineoplastic Agents administration & dosage MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Aged MeSH
- Vincristine administration & dosage MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Research Support, N.I.H., Extramural MeSH
BACKGROUND: Based on the encouraging activity and manageable safety profile observed in a phase 1 study, the ECHELON-2 trial was initiated to compare the efficacy and safety of brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (A+CHP) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for the treatment of CD30-positive peripheral T-cell lymphomas. METHODS: ECHELON-2 is a double-blind, double-dummy, randomised, placebo-controlled, active-comparator phase 3 study. Eligible adults from 132 sites in 17 countries with previously untreated CD30-positive peripheral T-cell lymphomas (targeting 75% with systemic anaplastic large cell lymphoma) were randomly assigned 1:1 to receive either A+CHP or CHOP for six or eight 21-day cycles. Randomisation was stratified by histological subtype according to local pathology assessment and by international prognostic index score. All patients received cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1 of each cycle intravenously and prednisone 100 mg once daily on days 1 to 5 of each cycle orally, followed by either brentuximab vedotin 1·8 mg/kg and a placebo form of vincristine intravenously (A+CHP group) or vincristine 1·4 mg/m2 and a placebo form of brentuximab vedotin intravenously (CHOP group) on day 1 of each cycle. The primary endpoint, progression-free survival according to blinded independent central review, was analysed by intent-to-treat. This trial is registered with ClinicalTrials.gov, number NCT01777152. FINDINGS: Between Jan 24, 2013, and Nov 7, 2016, 601 patients assessed for eligibility, of whom 452 patients were enrolled and 226 were randomly assigned to both the A+CHP group and the CHOP group. Median progression-free survival was 48·2 months (95% CI 35·2-not evaluable) in the A+CHP group and 20·8 months (12·7-47·6) in the CHOP group (hazard ratio 0·71 [95% CI 0·54-0·93], p=0·0110). Adverse events, including incidence and severity of febrile neutropenia (41 [18%] patients in the A+CHP group and 33 [15%] in the CHOP group) and peripheral neuropathy (117 [52%] in the A+CHP group and 124 [55%] in the CHOP group), were similar between groups. Fatal adverse events occurred in seven (3%) patients in the A+CHP group and nine (4%) in the CHOP group. INTERPRETATION: Front-line treatment with A+CHP is superior to CHOP for patients with CD30-positive peripheral T-cell lymphomas as shown by a significant improvement in progression-free survival and overall survival with a manageable safety profile. FUNDING: Seattle Genetics Inc, Millennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmacuetical Company Limited, and National Institutes of Health National Cancer Institute Cancer Center.
Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy
Calvary Mater Newcastle Hospital Waratah NSW Australia
China Medical University Hospital Taichung Taiwan
Columbia University Medical Center New York NY USA
Freeman Hospital Newcastle upon Tyne UK
Hackensack University Medical Center Hackensack NJ USA
Institut Catala D'oncologia L'Hospitalet de Llobregat Barcelona Spain
Institute of Hematology Seràgnoli University of Bologna Bologna Italy
MD Anderson Cancer Center University of Texas Houston TX USA
Memorial Sloan Kettering Cancer Center New York NY USA
National Cancer Center Hospital Tokyo Japan
Odense University Hospital Odense Denmark
Saitama Medical University International Medical Center Saitama Japan
Samsung Medical Center Seoul South Korea
Seattle Genetics Inc Bothell WA USA
Stanford Cancer Center Blood and Marrow Transplant Program Stanford CA USA
Universitatsklinikum Essen Essen Nordrhein Westfalen Germany
Universitätsmedizin Göttingen Göttingen Germany
University of Debrecen Faculty of Medicine Department of Hematology Debrecen Hungary
References provided by Crossref.org
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