Intermediate-Dose Cytarabine as Postinduction AML Therapy.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Hunault Mathilde, Pautas Cécile, Bertoli Sarah, Dumas Pierre-Yves, Raffoux Emmanuel, Hospital Marie-Anne, Marchand Tony, Heiblig Maël, Chantepie Sylvain, Carré Martin, Peterlin Pierre, Gallego-Hernanz Maria-Pilar, Lemasle Emilie, Guièze Romain, Simand Célestine, Turlure Pascal, Huynh Anne, Leguay Thibaut, Devillier Raynier, Quoc Stéphanie Nguyen, Duployez Nicolas, Luquet Isabelle, Penther Dominique, Celli-Lebras Karine, Mineur Ariane, Raus Nicole, Gardin Claude, Socié Gérard, Cahn Jean-Yves, Ifrah Norbert, Vey Norbert, de Latour Régis Peffault, Delabesse Eric, Preudhomme Claude, Hamel Jean-François, Pigneux Arnaud, Récher Christian, Dombret Hervé
Аннотация
METHODS: Patients 18 to 60 years of age with newly diagnosed AML, except those with core-binding factor, acute promyelocytic, Philadelphia chromosome-positive, or post-myeloproliferative neoplasm AML, were eligible. After the induction course, we randomly assigned patients to either IDAC (1500 mg/m2/12 hours) or HDAC (3000 mg/m2/12 hours). Patients with intermediate- and adverse-risk AML were eligible for allogeneic hematopoietic stem cell transplantation (HSCT) in first remission. The primary end point was OS in a predefined per-protocol analysis population. The primary analyses were performed in 1132 randomly assigned patients, with a noninferiority outcome adjusted on the European Leukemia Net (ELN) 2022 risk group, the use of induction anthracycline, the response to induction, and HSCT as a function of time following treatment.
RESULTS: At 5 years, OS was estimated at 59.3% (95% confidence interval [CI], 55.0 to 63.3) in the IDAC group versus 57.5% (95% CI, 53.3 to 61.5) in the HDAC group (adjusted hazard ratio, 0.96; 95% CI, 0.80 to 1.15; noninferiority test, P=0.0042). A preplanned analysis was unable to detect any interaction between IDAC or HDAC treatment effect and patient subgroups, including those defined by the ELN 2022 risk group or response to induction prior to random assignment. In addition, the severity of chemotherapy-induced myelosuppression and the incidence of related adverse events were lower after IDAC.
CONCLUSIONS: Our trial shows noninferior outcomes in patients 18 to 60 years of age with newly diagnosed AML treated with low- versus high-dose cytarabine; this occurred with similar or lower toxicities. (Funded by the Regional Clinical Research Office, Angers and others; EudraCT number, 2014-000699-24; ClinicalTrials.gov number, NCT02416388.).