Brentuximab vedotin with chemotherapy for ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Brentuximab vedotin with chemotherapy for cd30-positive peripheral t-cell lymphoma (echelon-2): a global, double-blind, randomised, phase 3 trial
Author(s) :
Horwitz, Steven [Auteur]
O''''connor, Owen A. [Auteur]
Pro, Barbara [Auteur]
Illidge, Tim [Auteur]
Fanale, Michelle [Auteur]
Advani, Ranjana [Auteur]
Bartlett, Nancy L. [Auteur]
Christensen, Jacob Haaber [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Domingo-Domenech, Eva [Auteur]
Rossi, Giuseppe [Auteur]
Kim, Won Seog [Auteur]
Feldman, Tatyana [Auteur]
Lennard, Anne [Auteur]
Belada, David [Auteur]
Illes, Arpad [Auteur]
Tobinai, Kensei [Auteur]
Tsukasaki, Kunihiro [Auteur]
Yeh, Su-Peng [Auteur]
Shustov, Andrei [Auteur]
Huttmann, Andreas [Auteur]
Savage, Kerry J. [Auteur]
Yuen, Sam [Auteur]
Iyer, Swaminathan [Auteur]
Zinzani, Pier Luigi [Auteur]
Hua, Zhaowei [Auteur]
Little, Meredith [Auteur]
Rao, Shangbang [Auteur]
Woolery, Joseph [Auteur]
Manley, Thomas [Auteur]
Trumper, Lorenz [Auteur]
O''''connor, Owen A. [Auteur]
Pro, Barbara [Auteur]
Illidge, Tim [Auteur]
Fanale, Michelle [Auteur]
Advani, Ranjana [Auteur]
Bartlett, Nancy L. [Auteur]
Christensen, Jacob Haaber [Auteur]
Morschhauser, Franck [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Domingo-Domenech, Eva [Auteur]
Rossi, Giuseppe [Auteur]
Kim, Won Seog [Auteur]
Feldman, Tatyana [Auteur]
Lennard, Anne [Auteur]
Belada, David [Auteur]
Illes, Arpad [Auteur]
Tobinai, Kensei [Auteur]
Tsukasaki, Kunihiro [Auteur]
Yeh, Su-Peng [Auteur]
Shustov, Andrei [Auteur]
Huttmann, Andreas [Auteur]
Savage, Kerry J. [Auteur]
Yuen, Sam [Auteur]
Iyer, Swaminathan [Auteur]
Zinzani, Pier Luigi [Auteur]
Hua, Zhaowei [Auteur]
Little, Meredith [Auteur]
Rao, Shangbang [Auteur]
Woolery, Joseph [Auteur]
Manley, Thomas [Auteur]
Trumper, Lorenz [Auteur]
Journal title :
Lancet (London, England)
Abbreviated title :
Lancet
Publication date :
2018-12-03
ISSN :
1474-547X
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
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 ...
Show more >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. 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/m222 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. 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. 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.Show less >
Show more >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. 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/m222 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. 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. 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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Université de Lille
Université de Lille
Collections :
Research team(s) :
Modélisation biopharmaceutique et pharmacocinétique
Submission date :
2019-12-16T14:06:39Z