title: Feasibility and efficacy of outpatient therapy with intermediate dose cytarabine, fludarabine and idarubicin for patients with acute myeloid leukaemia aged 70 or older.
abstract: OBJECTIVE
  A multicentre prospective non-randomised study of de novo acute myeloid leukaemia (AML) in patients aged ≥70 yr was designed to reduce toxicity and achieve acceptable complete remission (CR) rates.
  
  
  METHODS
  The outpatient treatment included induction with oral fludarabine, subcutaneous cytarabine and subcutaneous filgrastim (FAG). The patients received more induction cycles according to the response achieved. If there was no response to induction with FAG, the following induction cycle included oral idarubicin, subcutaneous cytarabine and subcutaneous filgrastim (IAG). Patients achieving CR received one intensification (FAG on response to previous FAG or alternatively IAG) and one consolidation cycle (IAG).
  
  
  RESULTS
  Thirty patients were enrolled from April 2004 to June 2007. The median age was 73 yr (range 70-77). Fifteen patients (50%) achieved CR. The 2-yr DFS was 29% (95% CI, 5-47%), and the 2-yr OS was 23% (95% CI, 12-35%). Twenty-five of 69 cycles (36%) were managed on a completely outpatient basis. The median hospital stay per cycle was 10 d (95% CI, 3-25).
  
  
  CONCLUSIONS
  This study demonstrates the tolerability and efficacy of a semi-intensive treatment in elderly de novo patients with AML managed on an outpatient basis, without substantial toxicity.
authors.affiliation: Haematology Department, ICO-Hospital Germans Trias i Pujol, Badalona, Spain.|Haematology Department, Jose Carreras Leukaemia Research Institute, Universitat Autonòma of Barcelona, Barcelona, Spain.
authors.forename: Susana
authors.initials: S
authors.lastname: Vives
authors.affiliation: Haematology Department, ICO-Hospital Germans Trias i Pujol, Badalona, Spain.|Haematology Department, Jose Carreras Leukaemia Research Institute, Universitat Autonòma of Barcelona, Barcelona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.affiliation: Haematology Department, Hospital Taulí, Sabadell, Spain.
authors.forename: Sònia
authors.initials: S
authors.lastname: Piernas
authors.affiliation: Haematology Department, Jose Carreras Leukaemia Research Institute, Universitat Autonòma of Barcelona, Barcelona, Spain.|Haematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Salut
authors.initials: S
authors.lastname: Brunet
authors.affiliation: Haematology Department, ICO-Hospital Duran y Reynals, Barcelona, Spain.
authors.forename: Victòria
authors.initials: V
authors.lastname: Clapés
authors.affiliation: Haematology Department, ICO-Hospital Josep Trueta, Girona, Spain.
authors.forename: Ramon
authors.initials: R
authors.lastname: Guardia
authors.affiliation: Haematology Department, Hospital Althaia, Manresa, Spain.
authors.forename: Maricel
authors.initials: M
authors.lastname: Subirà
authors.affiliation: Haematology Department, Jose Carreras Leukaemia Research Institute, Universitat Autonòma of Barcelona, Barcelona, Spain.|Haematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Sierra
authors.affiliation: Haematology Department, ICO-Hospital Germans Trias i Pujol, Badalona, Spain.|Haematology Department, Jose Carreras Leukaemia Research Institute, Universitat Autonòma of Barcelona, Barcelona, Spain.
authors.forename: Josep-Maria
authors.initials: JM
authors.lastname: Ribera
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000473:pathology; D003561:Cytarabine / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D016019:Survival Analysis; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D003561:Cytarabine; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin
keywords: AML; elderly patients; intermediate dose cytarabine; outpatient management