-
Je něco špatně v tomto záznamu ?
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....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, Research Support, N.I.H., Extramural, práce podpořená grantem
NLK
ProQuest Central
od 1992-01-04 do Před 3 měsíci
Nursing & Allied Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Health & Medicine (ProQuest)
od 1992-01-04 do Před 3 měsíci
Family Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Psychology Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Health Management Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Public Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
- MeSH
- analýza podle původního léčebného záměru MeSH
- anaplastický velkobuněčný lymfom farmakoterapie MeSH
- cyklofosfamid aplikace a dávkování MeSH
- dospělí MeSH
- doxorubicin aplikace a dávkování MeSH
- dvojitá slepá metoda MeSH
- imunokonjugáty aplikace a dávkování škodlivé účinky MeSH
- imunologické faktory aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- prednison aplikace a dávkování MeSH
- přežití bez známek nemoci MeSH
- protinádorové látky aplikace a dávkování MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- senioři MeSH
- vinkristin aplikace a dávkování MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie 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
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19012049
- 003
- CZ-PrNML
- 005
- 20240313110317.0
- 007
- ta
- 008
- 190405s2019 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/S0140-6736(18)32984-2 $2 doi
- 035 __
- $a (PubMed)30522922
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Horwitz, Steven $u Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: horwitzs@mskcc.org.
- 245 10
- $a Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial / $c 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. Shustov, A. Hüttmann, KJ. Savage, S. Yuen, S. Iyer, PL. Zinzani, Z. Hua, M. Little, S. Rao, J. Woolery, T. Manley, L. Trümper, . ,
- 520 9_
- $a 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.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a protinádorové látky $x aplikace a dávkování $7 D000970
- 650 _2
- $a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $7 D000971
- 650 _2
- $a cyklofosfamid $x aplikace a dávkování $7 D003520
- 650 _2
- $a přežití bez známek nemoci $7 D018572
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a doxorubicin $x aplikace a dávkování $7 D004317
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a imunokonjugáty $x aplikace a dávkování $x škodlivé účinky $7 D018796
- 650 _2
- $a imunologické faktory $x aplikace a dávkování $x škodlivé účinky $7 D007155
- 650 _2
- $a analýza podle původního léčebného záměru $7 D057194
- 650 _2
- $a anaplastický velkobuněčný lymfom $x farmakoterapie $7 D017728
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a prednison $x aplikace a dávkování $7 D011241
- 650 _2
- $a vinkristin $x aplikace a dávkování $7 D014750
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a Research Support, N.I.H., Extramural $7 D052061
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a O'Connor, Owen A $u Columbia University Medical Center, New York, NY, USA.
- 700 1_
- $a Pro, Barbara $u Division of Hematology and Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
- 700 1_
- $a Illidge, Tim $u Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, National Institutes of Health and Research Biomedical Research Centre, Manchester Academic Health Sciences Centre, Christie Hospital National Health Service Foundation Trust, Manchester, UK.
- 700 1_
- $a Fanale, Michelle $u MD Anderson Cancer Center, University of Texas, Houston, TX, USA; Seattle Genetics, Inc, Bothell, WA, USA.
- 700 1_
- $a Advani, Ranjana $u Stanford Cancer Center, Blood and Marrow Transplant Program, Stanford, CA, USA.
- 700 1_
- $a Bartlett, Nancy L $u Washington University School of Medicine, St Louis, MI, USA.
- 700 1_
- $a Christensen, Jacob Haaber $u Odense University Hospital, Odense, Denmark.
- 700 1_
- $a Morschhauser, Franck $u University of Lille, Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.
- 700 1_
- $a Domingo-Domenech, Eva $u Institut Catala D'oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.
- 700 1_
- $a Rossi, Giuseppe $u Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy.
- 700 1_
- $a Kim, Won Seog $u Samsung Medical Center, Seoul, South Korea.
- 700 1_
- $a Feldman, Tatyana $u Hackensack University Medical Center, Hackensack, NJ, USA.
- 700 1_
- $a Lennard, Anne $u Freeman Hospital, Newcastle upon Tyne, UK.
- 700 1_
- $a Belada, David $u 4th Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.
- 700 1_
- $a Illés, Árpád $u University of Debrecen, Faculty of Medicine, Department of Hematology, Debrecen, Hungary.
- 700 1_
- $a Tobinai, Kensei $u National Cancer Center Hospital, Tokyo, Japan.
- 700 1_
- $a Tsukasaki, Kunihiro $u Saitama Medical University International Medical Center, Saitama, Japan.
- 700 1_
- $a Yeh, Su-Peng $u China Medical University Hospital, Taichung, Taiwan.
- 700 1_
- $a Shustov, Andrei $u University of Washington Medical Center, Seattle, WA, USA.
- 700 1_
- $a Hüttmann, Andreas $u Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany.
- 700 1_
- $a Savage, Kerry J $u University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, BC, Canada.
- 700 1_
- $a Yuen, Sam $u Calvary Mater Newcastle Hospital, Waratah, NSW, Australia.
- 700 1_
- $a Iyer, Swaminathan $u MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
- 700 1_
- $a Zinzani, Pier Luigi, $d 1959- $u Institute of Hematology Seràgnoli, University of Bologna, Bologna, Italy. $7 xx0314852
- 700 1_
- $a Hua, Zhaowei $u Millennium Pharmaceuticals, Inc, Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company.
- 700 1_
- $a Little, Meredith $u Millennium Pharmaceuticals, Inc, Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company.
- 700 1_
- $a Rao, Shangbang $u Seattle Genetics, Inc, Bothell, WA, USA.
- 700 1_
- $a Woolery, Joseph $u Seattle Genetics, Inc, Bothell, WA, USA.
- 700 1_
- $a Manley, Thomas $u Seattle Genetics, Inc, Bothell, WA, USA.
- 700 1_
- $a Trümper, Lorenz, $u Universitätsmedizin Göttingen, Göttingen, Germany. $d 1958- $7 xx0269964
- 700 1_
- $a ,
- 773 0_
- $w MED00010161 $t Lancet $x 1474-547X $g Roč. 393, č. 10168 (2019), s. 229-240
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/30522922 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20190405 $b ABA008
- 991 __
- $a 20240313110313 $b ABA008
- 999 __
- $a ok $b bmc $g 1391359 $s 1050354
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2019 $b 393 $c 10168 $d 229-240 $e 20181204 $i 1474-547X $m Lancet $n Lancet $x MED00010161
- LZP __
- $a Pubmed-20190405
