title: Phase II trial of vorinostat and gemtuzumab ozogamicin as induction and post-remission therapy in older adults with previously untreated acute myeloid leukemia.
abstract: Histone deacetylase inhibitors such as vorinostat enhance gemtuzumab ozogamicin efficacy in vitro. We, therefore, investigated vorinostat+gemtuzumab ozogamicin for adults aged 60 years and over with untreated acute myeloid leukemia. We stratified patients into 2 groups (group 1: patients aged ≥ 70 years and performance status 2-3; group 2: aged 60-69 years with performance status 0-3 or aged ≥ 70 years and performance status 0-1). Responses were monitored separately in group 2 patients with normal or favorable cytogenetics (group 2A) and other cytogenetics (group 2B). Among 31 patients, 6 (19.4%) achieved complete remission, and one (3.2%) achieved complete remission with incomplete platelet recovery; these patients had a higher median overall survival than non-responders (553 vs. 131 days, P = 0.0026). Response rates were: group 1, one of 10 (10.0%); group 2A, 6 of 13 (46.2%); and group 2B, none of 8 (0%). These data indicate that vorinostat+gemtuzumab ozogamicin has activity that is mostly confined to patients with normal karyotype disease. ClinicalTrial.gov: NCT00673153.
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. rwalter@fhcrc.org
authors: Roland B
authors: RB
authors: Walter
authors: Bruno C
authors: BC
authors: Medeiros
authors: Bayard L
authors: BL
authors: Powell
authors: Charles A
authors: CA
authors: Schiffer
authors: Frederick R
authors: FR
authors: Appelbaum
authors: Elihu H
authors: EH
authors: Estey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D006877:Hydroxamic Acids / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012074:Remission Induction; D015996:Survival Rate; D000077337:Vorinostat
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D006877:Hydroxamic Acids; D000077337:Vorinostat; D000079982:Gemtuzumab