title: Azacitidine for the treatment of relapsed and refractory AML in older patients.
abstract: The prognosis of patients older than 50 with relapsed or refractory AML is dismal. Azacitidine has been investigated in older AML patients. Here we report the outcome of 130 patients older than 50 years included in a multicenter patient named program of azacitidine after relapse (n=67) or induction failure (n=63) of intensive chemotherapy. Median age was 67 years, cytogenetic risk was high in 28% and performance status ≥2 in 15% of cases. Most (72%) patients received azacitidine at the standard schedule (75mg/m(2)/d, 7 days/month) for a median of 4 courses. The overall response rate was 17% (CR: 10%, CRi: 7%). Median overall survival was 8.4 months. Achievement of CR/CRi was associated with prolonged survival (P=0.0001), whereas hematological improvement according to MDS criteria, achieved in 36% of patients with resistant disease, did not improve survival. In multivariate analysis, high risk cytogenetics (P=0.022) and peripheral blasts >10% (P<0.0001) at onset of azacitidine were independently predictive of poor prognosis. Combining these two factors, we identified a subgroup of 48% of patients with intermediate risk cytogenetics and peripheral blasts ≤10% and a median OS of 11.3 months. These results warrant further investigation of azacitidine-based regimens in this subgroup of patients.
authors.affiliation: Département d'Hématologie, Hôpital Saint-Louis, Assistance Publique des Hôpitaux de Paris (AP-HP) and Université Paris 7, Paris, France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Itzykson
authors.affiliation: Service d'Hématologie Clinique, Hôpital Avicenne, AP-HP, and Université Paris 13, Bobigny, France.
authors.forename: Sylvain
authors.initials: S
authors.lastname: Thépot
authors.affiliation: Service des Maladies du Sang, Centre Hospitalier Universitaire, Lille, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Berthon
authors.affiliation: Service d'Hématologie, Centre Hospitalier Universitaire, Nantes, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Delaunay
authors.affiliation: Service d'Hématologie Clinique, Hôpital Cochin, AP-HP and Université Paris 5, Paris, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Bouscary
authors.affiliation: Service d'Hématologie, Centre Hospitalier Universitaire, Nice, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Cluzeau
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Limoges, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Turlure
authors.affiliation: Département d'Hématologie, Institut Paoli-Calmettes, Marseille, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Prébet
authors.affiliation: Service d'Oncologie et Maladies du Sang, Centre Hospitalier Universitaire, Tours, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Dartigeas
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Amiens, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marolleau
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Toulouse, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Recher
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier, Roubaix, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Plantier
authors.affiliation: Service d'Hématologie, Centre Henri Becquerel, Rouen, France.
authors.forename: Aspasia
authors.initials: A
authors.lastname: Stamatoullas
authors.affiliation: Service d'Hématologie, Centre Hospitalier du Sud Francilien, Corbeil, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Devidas
authors.affiliation: Service d'Hématologie, Centre Hospitalier, Versailles, Université Versailles-Saint Quentin, Le Chesnay, France.
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Taksin
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Clermont-Ferrand, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Guièze
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Dijon, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Caillot
authors.affiliation: Département d'Hématologie, Institut Paoli-Calmettes, Marseille, France.
authors.forename: Norbert
authors.initials: N
authors.lastname: Vey
authors.affiliation: Département d'Hématologie, Hôpital Saint-Louis, Assistance Publique des Hôpitaux de Paris (AP-HP) and Université Paris 7, Paris, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Adès
authors.affiliation: Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Angers, France.
authors.forename: Norbert
authors.initials: N
authors.lastname: Ifrah
authors.affiliation: Département d'Hématologie, Hôpital Saint-Louis, Assistance Publique des Hôpitaux de Paris (AP-HP) and Université Paris 7, Paris, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
authors.affiliation: Département d'Hématologie, Hôpital Saint-Louis, Assistance Publique des Hôpitaux de Paris (AP-HP) and Université Paris 7, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.affiliation: Service d'Hématologie Clinique, Hôpital Avicenne, AP-HP, and Université Paris 13, Bobigny, France. Electronic address: claude.gardin@avc.aphp.fr.
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001374:Azacitidine / Q000008:administration & dosage*; D001752:Blast Crisis / Q000188:drug therapy* / Q000401:mortality*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine
keywords: Acute myeloid leukemia; Azacitidine; Induction failure; Relapse