title: Hydroxyurea, azacitidine and gemtuzumab ozogamicin therapy in patients with previously untreated non-M3 acute myeloid leukemia and high-risk myelodysplastic syndromes in the elderly: results from a pilot trial.
abstract: Elderly patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) have a poor prognosis due to low response rates (26-46%) to standard chemotherapy and high treatment-related mortality (11-31%). In this Phase II study, we used a combination of hydroxyurea (HU), azacitidine and low dose gemtuzumab ozogamicin (GO) to assess its efficacy and toxicity in this group of patients. Twenty patients with non-M3 AML and MDS were treated with this regimen. The treatment was begun with HU 1500 mg orally twice daily to lower white blood cell count below 10,000/microL, followed by azacitidine 75 mg/m(2) subcutaneously for 7 days and GO 3 mg/m(2) on day 8. Patients who achieved complete remission (CR) received a consolidation course. The median age of patients was 76 years. Eleven patients (55%) were treated in the outpatient setting. Fourteen (70%) achieved a CR, three of which were incomplete (CRi). The median duration of remission was 8 months and median survival was 10 months. Performance status of 0-1 was associated with high complete response rate. Overall toxicity was acceptable with only one (5%) early death due to disease progression. The combination of HU, azacitdine and GO appears to be a safe and effective regimen in the treatment of AML and high risk MDS in the elderly. These results need to be confirmed in a larger cohort of patients.
authors.affiliation: Department of Medicine, Loyola University Medical Centre, Division of Hematology Oncology, Maywood, IL 60153, USA. snand@lumc.edu
authors.forename: Sucha
authors.initials: S
authors.lastname: Nand
authors.forename: John
authors.initials: J
authors.lastname: Godwin
authors.forename: Scott
authors.initials: S
authors.lastname: Smith
authors.forename: Kevin
authors.initials: K
authors.lastname: Barton
authors.forename: Laura
authors.initials: L
authors.lastname: Michaelis
authors.forename: Serhan
authors.initials: S
authors.lastname: Alkan
authors.forename: Ranjitha
authors.initials: R
authors.lastname: Veerappan
authors.forename: Karen
authors.initials: K
authors.lastname: Rychlik
authors.forename: Eliza
authors.initials: E
authors.lastname: Germano
authors.forename: Patrick
authors.initials: P
authors.lastname: Stiff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000008:administration & dosage; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D001374:Azacitidine / Q000008:administration & dosage; D064420:Drug-Related Side Effects and Adverse Reactions; D000079982:Gemtuzumab; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000401:mortality / Q000628:therapy*; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000401:mortality / Q000628:therapy*; D010865:Pilot Projects; D012074:Remission Induction; D018570:Risk Assessment; D016019:Survival Analysis
chemical_list: D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab; D001374:Azacitidine; D006918:Hydroxyurea