Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study.
- Fenaux P
- Mufti GJ
- Hellstrom Lindberg E
- Santini V
- Finelli C
- Giagounidis A
- Schoch R
- Gattermann N
- Sanz G
- List A
- Gore SD
- Seymour JF
- Bennett JM
- Byrd J
- Backstrom J
- Zimmerman L
- McKenzie D
- Beach C
- Silverman LR
- Durrant S
- Enno A
- Herrmann R
- Horvath N
- Mills A
- Spencer A
- Szer J
- Gallo J
- Dunlop L
- Arthur C
- Goranov S
- Peytchev D
- Gercheva L
- Cermak J
- Voglova J
- Vey N
- Dreyfus F
- Laurent G
- Quesnel B
- Dombret H
- Stamatoullas A
- Wattel E
- Hunault Berger M
- Aul C
- Giagounidis A
- Duhrsen U
- Gattermann N
- Platzbecker U
- Schmid M
- Hanel M
- Haase D
- Fiedler W
- Schmitz N
- Hofmann W
- Horst H
- Anagnostopoulos N
- Pappa V
- Papadaki E
- Zoumbos N
- Borbenyi Z
- Masszi T
- Baccarani M
- Bacigalupo A
- Corradini P
- Leone G
- Bosi A
- Musto P
- Muus P
- Dmoszynska A
- Robak T
- Sulek K
- Kuliczkowski K
- Jedrzejczak W
- Zaritsky A
- Abdulkadyrov K
- Podoltseva E
- Afanasiev B
- Bargay J
- Brunet S
- Del Canizo C
- Ribera J
- Figuera Alvarez A
- Diaz Mediavilla J
- Canales M
- Ramos y. Ortega F
- Nilsson L
- Olsson A
- Cavenagh J
- Parker J
- Killick S
- Kruger A
- Vyas P
- Dennis M
- Cripe L
- DiPersio J
- Emanuel P.
- SACCHI, Stefano
DOIAbstract
BACKGROUND: Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens. METHODS: In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m(2) per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French-American-British and international prognostic scoring system cl...
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