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Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission
AH. Wei, H. Döhner, C. Pocock, P. Montesinos, B. Afanasyev, H. Dombret, F. Ravandi, H. Sayar, JH. Jang, K. Porkka, D. Selleslag, I. Sandhu, M. Turgut, V. Giai, Y. Ofran, M. Kizil Çakar, A. Botelho de Sousa, J. Rybka, C. Frairia, L. Borin, G....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
ProQuest Central
od 1980-01-03 do Před 3 měsíci
Nursing & Allied Health Database (ProQuest)
od 1980-01-03 do Před 3 měsíci
Health & Medicine (ProQuest)
od 1980-01-03 do Před 3 měsíci
Family Health Database (ProQuest)
od 1980-01-03 do Před 3 měsíci
Psychology Database (ProQuest)
od 1980-01-03 do Před 3 měsíci
Health Management Database (ProQuest)
od 1980-01-03 do Před 3 měsíci
Public Health Database (ProQuest)
od 1980-01-03 do Před 3 měsíci
PubMed
33369355
DOI
10.1056/nejmoa2004444
Knihovny.cz E-zdroje
- MeSH
- akutní myeloidní leukemie farmakoterapie mortalita MeSH
- analýza přežití MeSH
- antimetabolity antitumorózní aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- aplikace orální MeSH
- azacytidin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- dvojitá slepá metoda MeSH
- indukce remise MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- nauzea chemicky indukované MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- rozvrh dávkování léků MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- udržovací chemoterapie * škodlivé účinky MeSH
- Check Tag
- 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
BACKGROUND: Although induction chemotherapy results in remission in many older patients with acute myeloid leukemia (AML), relapse is common and overall survival is poor. METHODS: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of the oral formulation of azacitidine (CC-486, a hypomethylating agent that is not bioequivalent to injectable azacitidine), as maintenance therapy in patients with AML who were in first remission after intensive chemotherapy. Patients who were 55 years of age or older, were in complete remission with or without complete blood count recovery, and were not candidates for hematopoietic stem-cell transplantation were randomly assigned to receive CC-486 (300 mg) or placebo once daily for 14 days per 28-day cycle. The primary end point was overall survival. Secondary end points included relapse-free survival and health-related quality of life. RESULTS: A total of 472 patients underwent randomization; 238 were assigned to the CC-486 group and 234 were assigned to the placebo group. The median age was 68 years (range, 55 to 86). Median overall survival from the time of randomization was significantly longer with CC-486 than with placebo (24.7 months and 14.8 months, respectively; P<0.001). Median relapse-free survival was also significantly longer with CC-486 than with placebo (10.2 months and 4.8 months, respectively; P<0.001). Benefits of CC-486 with respect to overall and relapse-free survival were shown in most subgroups defined according to baseline characteristics. The most common adverse events in both groups were grade 1 or 2 gastrointestinal events. Common grade 3 or 4 adverse events were neutropenia (in 41% of patients in the CC-486 group and 24% of patients in the placebo group) and thrombocytopenia (in 22% and 21%, respectively). Overall health-related quality of life was preserved during CC-486 treatment. CONCLUSIONS: CC-486 maintenance therapy was associated with significantly longer overall and relapse-free survival than placebo among older patients with AML who were in remission after chemotherapy. Side effects were mainly gastrointestinal symptoms and neutropenia. Quality-of-life measures were maintained throughout treatment. (Supported by Celgene; QUAZAR AML-001 ClinicalTrials.gov number, NCT01757535.).
Amsterdam University Medical Center Location VUMC Amsterdam
Antonio e Biagio e Cesare Arrigo Hospital Alessandria
AZ Sint Jan Brugge Oostende AV Bruges Belgium
Bristol Myers Squibb Princeton NJ
Città della Salute e della Scienza Turin Italy
Department of Internal Medicine 3 Ulm University Hospital Ulm Germany
Department of Leukemia University of Texas M D Anderson Cancer Center Houston
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ankara Turkey
Hospital dos Capuchos Centro Hospitalar Universitário de Lisboa Central Lisbon Portugal
Indiana University Cancer Center Indianapolis
Kent and Canterbury Hospital Canterbury United Kingdom
Ondokuz Mayis University Samsun Turkey
Ospedale Policlinico San Martino Genoa Italy
Ospedale San Gerardo Monza Monza Italy
Rambam Medical Center and Faculty of Medicine Technion Haifa Israel
Samsung Medical Center Sungkyunkwan University School of Medicine Seoul South Korea
University of Alberta Hospital Edmonton Canada
University of Kansas Medical Center Kansas City
Ústav Hematologie a Krevní Transfuze Prague Czech Republic
Weill Cornell Medicine and New York Presbyterian Hospital New York
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- $a Wei, Andrew H $u From the Department of Clinical Haematology, Alfred Hospital, and the Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia
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- $a Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission / $c AH. Wei, H. Döhner, C. Pocock, P. Montesinos, B. Afanasyev, H. Dombret, F. Ravandi, H. Sayar, JH. Jang, K. Porkka, D. Selleslag, I. Sandhu, M. Turgut, V. Giai, Y. Ofran, M. Kizil Çakar, A. Botelho de Sousa, J. Rybka, C. Frairia, L. Borin, G. Beltrami, J. Čermák, GJ. Ossenkoppele, I. La Torre, B. Skikne, K. Kumar, Q. Dong, CL. Beach, GJ. Roboz, QUAZAR AML-001 Trial Investigators
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- $a BACKGROUND: Although induction chemotherapy results in remission in many older patients with acute myeloid leukemia (AML), relapse is common and overall survival is poor. METHODS: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of the oral formulation of azacitidine (CC-486, a hypomethylating agent that is not bioequivalent to injectable azacitidine), as maintenance therapy in patients with AML who were in first remission after intensive chemotherapy. Patients who were 55 years of age or older, were in complete remission with or without complete blood count recovery, and were not candidates for hematopoietic stem-cell transplantation were randomly assigned to receive CC-486 (300 mg) or placebo once daily for 14 days per 28-day cycle. The primary end point was overall survival. Secondary end points included relapse-free survival and health-related quality of life. RESULTS: A total of 472 patients underwent randomization; 238 were assigned to the CC-486 group and 234 were assigned to the placebo group. The median age was 68 years (range, 55 to 86). Median overall survival from the time of randomization was significantly longer with CC-486 than with placebo (24.7 months and 14.8 months, respectively; P<0.001). Median relapse-free survival was also significantly longer with CC-486 than with placebo (10.2 months and 4.8 months, respectively; P<0.001). Benefits of CC-486 with respect to overall and relapse-free survival were shown in most subgroups defined according to baseline characteristics. The most common adverse events in both groups were grade 1 or 2 gastrointestinal events. Common grade 3 or 4 adverse events were neutropenia (in 41% of patients in the CC-486 group and 24% of patients in the placebo group) and thrombocytopenia (in 22% and 21%, respectively). Overall health-related quality of life was preserved during CC-486 treatment. CONCLUSIONS: CC-486 maintenance therapy was associated with significantly longer overall and relapse-free survival than placebo among older patients with AML who were in remission after chemotherapy. Side effects were mainly gastrointestinal symptoms and neutropenia. Quality-of-life measures were maintained throughout treatment. (Supported by Celgene; QUAZAR AML-001 ClinicalTrials.gov number, NCT01757535.).
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- $a Döhner, Hartmut $u Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany
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- $a Pocock, Christopher $u Kent and Canterbury Hospital, Canterbury, United Kingdom
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