-
Je něco špatně v tomto záznamu ?
Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial
AH. Wei, P. Montesinos, V. Ivanov, CD. DiNardo, J. Novak, K. Laribi, I. Kim, DA. Stevens, W. Fiedler, M. Pagoni, O. Samoilova, Y. Hu, A. Anagnostopoulos, J. Bergeron, JZ. Hou, V. Murthy, T. Yamauchi, A. McDonald, B. Chyla, S. Gopalakrishnan, Q....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
Freely Accessible Science Journals od 1946 do Před 1 rokem
Open Access Digital Library od 1946-01-01
Open Access Digital Library od 1946-01-01
Elsevier Open Access Journals od 1946-01-01 do 2023-06-22
ROAD: Directory of Open Access Scholarly Resources
Elsevier Open Archive Journals od 1946 do Před 1 rokem
Odkazy
PubMed
32219442
DOI
10.1182/blood.2020004856
Knihovny.cz E-zdroje
- MeSH
- akutní myeloidní leukemie farmakoterapie genetika mortalita MeSH
- bicyklické sloučeniny heterocyklické aplikace a dávkování MeSH
- cytarabin aplikace a dávkování MeSH
- dospělí MeSH
- indukce remise MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mutace MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sulfonamidy aplikace a dávkování MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let 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
Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.
3rd Faculty of Medicine Charles University Prague Czech Republic
Almazov National Medical Research Center Saint Petersburg Russia
Centre Hospitalier Le Mans Le Mans France
Centro de Investigación Biomedica en Red en Cancer Instituto Carlos 3 Madrid Spain
Department of Leukemia The University of Texas MD Anderson Cancer Center Houston TX
Evaggelismos General Hospital Athens Greece
George Papanicolaou General Hospital Thessaloniki Greece
Heartlands Hospital Birmingham United Kingdom
Hospital Universitario y Politecnico La Fe Valencia Spain
Hubertus Wald University Cancer Center University Medical Center Hamburg Eppendorf Hamburg Germany
Laiko General Hospital National and Kapodistrian University of Athens Medical School Athens Greece
Leukaemia Translational Research Central Clinical School Monash University Melbourne VIC Australia
Netcare Pretoria East Hospital Pretoria South Africa
Nizhny Novgorod Regional Clinical Hospital Nizhny Novgorod Russia
Norton Cancer Institute Louisville KY
Seoul National University Hospital Seoul South Korea
The Alfred Hospital Melbourne VIC Australia
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China
University of Fukui Hospital Fukui Japan
University of Pittsburgh Medical Center Cancer Center Pittsburgh PA
- 000
- 00000naa a2200000 a 4500
- 001
- bmc21012476
- 003
- CZ-PrNML
- 005
- 20240516081828.0
- 007
- ta
- 008
- 210420s2020 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1182/blood.2020004856 $2 doi
- 035 __
- $a (PubMed)32219442
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Wei, Andrew H $u The Alfred Hospital, Melbourne, VIC, Australia ; Leukaemia Translational Research, Central Clinical School, Monash University, Melbourne, VIC, Australia
- 245 10
- $a Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial / $c AH. Wei, P. Montesinos, V. Ivanov, CD. DiNardo, J. Novak, K. Laribi, I. Kim, DA. Stevens, W. Fiedler, M. Pagoni, O. Samoilova, Y. Hu, A. Anagnostopoulos, J. Bergeron, JZ. Hou, V. Murthy, T. Yamauchi, A. McDonald, B. Chyla, S. Gopalakrishnan, Q. Jiang, W. Mendes, J. Hayslip, P. Panayiotidis
- 520 9_
- $a Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a senioři nad 80 let $7 D000369
- 650 _2
- $a protokoly antitumorózní kombinované chemoterapie $x aplikace a dávkování $7 D000971
- 650 _2
- $a bicyklické sloučeniny heterocyklické $x aplikace a dávkování $7 D019086
- 650 _2
- $a cytarabin $x aplikace a dávkování $7 D003561
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a Kaplanův-Meierův odhad $7 D053208
- 650 _2
- $a akutní myeloidní leukemie $x farmakoterapie $x genetika $x mortalita $7 D015470
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a mutace $7 D009154
- 650 _2
- $a indukce remise $7 D012074
- 650 _2
- $a sulfonamidy $x aplikace a dávkování $7 D013449
- 650 _2
- $a výsledek terapie $7 D016896
- 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 práce podpořená grantem $7 D013485
- 700 1_
- $a Montesinos, Pau $u Hospital Universitario y Politecnico La Fe, Valencia, Spain ; Centro de Investigación Biomedica en Red en Cancer (CIBERONIC), Instituto Carlos III, Madrid, Spain
- 700 1_
- $a Ivanov, Vladimir $u Almazov National Medical Research Center, Saint Petersburg, Russia
- 700 1_
- $a DiNardo, Courtney D $u Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
- 700 1_
- $a Novak, Jan $u Department of Internal Medicine and Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic ; Third Faculty of Medicine, Charles University, Prague, Czech Republic
- 700 1_
- $a Laribi, Kamel $u Centre Hospitalier Le Mans, Le Mans, France
- 700 1_
- $a Kim, Inho $u Seoul National University Hospital, Seoul, South Korea
- 700 1_
- $a Stevens, Don A $u Norton Cancer Institute, Louisville, KY
- 700 1_
- $a Fiedler, Walter $u Hubertus Wald University Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
- 700 1_
- $a Pagoni, Maria $u Evaggelismos General Hospital, Athens Greece
- 700 1_
- $a Samoilova, Olga $u Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia
- 700 1_
- $a Hu, Yu $u Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
- 700 1_
- $a Anagnostopoulos, Achilles $u George Papanicolaou General Hospital, Thessaloniki, Greece
- 700 1_
- $a Bergeron, Julie $u Centre Intégré Universitaire de Santé et de Services Sociaux de l'Est-de-l'Île-de-Montréal (CIUSSSEMTL), Installation Maisonneuve-Rosemont, Montreal, QC, Canada $7 xx0317379
- 700 1_
- $a Hou, Jing-Zhou $u University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA
- 700 1_
- $a Murthy, Vidhya $u Heartlands Hospital, Birmingham, United Kingdom
- 700 1_
- $a Yamauchi, Takahiro $u University of Fukui Hospital, Fukui, Japan
- 700 1_
- $a McDonald, Andrew $u Netcare Pretoria East Hospital, Pretoria, South Africa
- 700 1_
- $a Chyla, Brenda $u AbbVie, Inc., North Chicago, IL; and
- 700 1_
- $a Gopalakrishnan, Sathej $u AbbVie, Inc., North Chicago, IL; and
- 700 1_
- $a Jiang, Qi $u AbbVie, Inc., North Chicago, IL; and
- 700 1_
- $a Mendes, Wellington $u AbbVie, Inc., North Chicago, IL; and
- 700 1_
- $a Hayslip, John $u AbbVie, Inc., North Chicago, IL; and
- 700 1_
- $a Panayiotidis, Panayiotis $u Laiko General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece
- 773 0_
- $w MED00000807 $t Blood $x 1528-0020 $g Roč. 135, č. 24 (2020), s. 2137-2145
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/32219442 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20210420 $b ABA008
- 991 __
- $a 20240516081823 $b ABA008
- 999 __
- $a ok $b bmc $g 1650773 $s 1132855
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2020 $b 135 $c 24 $d 2137-2145 $e 20200611 $i 1528-0020 $m Blood $n Blood $x MED00000807
- LZP __
- $a Pubmed-20210420