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Phase II trial of vorinostat and gemtuzumab ozogamicin as induction and post-remission therapy in older adults with previously untreated acute myeloid leukemia HAEMATOLOGICA-THE HEMATOLOGY JOURNAL Walter, R. B., Medeiros, B. C., Powell, B. L., Schiffer, C. A., Appelbaum, F. R., Estey, E. H. 2012; 97 (5): 739-742

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.

View details for DOI 10.3324/haematol.2011.055822

View details for Web of Science ID 000304669000020

View details for PubMedID 22133771

View details for PubMedCentralID PMC3342977