title: High-dose daunorubicin as liposomal compound (Daunoxome) in elderly patients with acute lymphoblastic leukemia.
abstract: Elderly acute lymphoblastic leukemia (ALL) is a rare condition associated with low complete remission (CR) rate and short survival. In order to improve these results, we evaluate the efficacy and toxicity of Daunoxome, a liposomal daunorubicin, exhibiting toxicity profile and pharmacokinetic indices better than standard daunorubicin. In total, 15 consecutive patients with nonmature ALL were enrolled on a prospective phase II study. No exclusion was made because of older age, poor performance status and organ dysfunctions. Median age was 69 years; performance status resulted >/=2 in nine patients (60%), six patients (40%) were bcr-abl positive and two-thirds of the patients had comorbidities. Induction therapy consisted of vincristine, Daunoxome and dexamethasone. Patients in CR received one or two consolidation cycles of cyclophosphamide, cytarabine and topotecan followed, in patients achieving CR, by a two-year rotating maintenance course including vincristine, Daunoxome, cyclophosphamide and prednisone. In all, 11 patients (73%) achieved CR, three patients (20%) died early during the induction phase and one patient (7%) had resistant disease. Five patients (33%) relapsed after 5-21 months. With a median follow-up of 20 months, disease free survival (DFS) and overall survival (OS) at 2 years were 36 and 38%, respectively. Major toxicity included myelosuppression and infection. Our experience demonstrates that a high dose of daunorubicin as liposomal compound can be safely administered in elderly ALL, exhibiting high antitumor activity. Our therapeutic program shows evidence of benefit in DFS and OS.
authors.affiliation: Clinica di Ematologia, Università degli Studi di Ancona, Azienda Ospedaliera Umberto I, Italy. m.offidani@ao-umbertoprimo.marche.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Laura
authors.initials: L
authors.lastname: Corvatta
authors.forename: Riccardo
authors.initials: R
authors.lastname: Centurioni
authors.forename: Franco
authors.initials: F
authors.lastname: Leoni
authors.forename: Lara
authors.initials: L
authors.lastname: Malerba
authors.forename: Anna
authors.initials: A
authors.lastname: Mele
authors.forename: Monica
authors.initials: M
authors.lastname: Marconi
authors.forename: Annarita
authors.initials: A
authors.lastname: Scortechini
authors.forename: M Cristiana
authors.initials: MC
authors.lastname: Masia
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001623:Betamethasone / Q000008:administration & dosage; D001855:Bone Marrow Diseases / Q000139:chemically induced; D002051:Burkitt Lymphoma / Q000188:drug therapy* / Q000401:mortality; D015897:Comorbidity; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004337:Drug Carriers; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007239:Infections / Q000209:etiology; D015458:Leukemia, T-Cell / Q000188:drug therapy / Q000401:mortality; D015993:Life Tables; D008081:Liposomes; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D015452:Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy / Q000401:mortality; D011446:Prospective Studies; D012074:Remission Induction; D012449:Safety; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004337:Drug Carriers; D008081:Liposomes; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D019772:Topotecan; D003520:Cyclophosphamide; D001623:Betamethasone; D008727:Methotrexate; D003630:Daunorubicin