Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2012 May;97(5):739-42.
doi: 10.3324/haematol.2011.055822. Epub 2011 Dec 1.

Phase II trial of vorinostat and gemtuzumab ozogamicin as induction and post-remission therapy in older adults with previously untreated acute myeloid leukemia

Roland B Walter  1 , Bruno C Medeiros, Bayard L Powell, Charles A Schiffer, Frederick R Appelbaum, Elihu H Estey
Affiliations
Clinical Trial

Phase II trial of vorinostat and gemtuzumab ozogamicin as induction and post-remission therapy in older adults with previously untreated acute myeloid leukemia

Roland B Walter et al. Haematologica. 2012 May.

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.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Kaplan-Meier estimates of the probability of survival for responders (i.e. patients who achieved CR or CRp, n=7) and non-responders (n=21); patients who died within the first 30 days of treatment initiation (n=3) were excluded from this analysis. Patients who achieved CR/CRp after induction therapy with vorinostat and GO had a statistically significantly better overall survival than those who failed therapy but lived at least 30 days after treatment initiation (log rank P=0.0026).
See this image and copyright information in PMC

References

    1. Howlader N, Noone AM, Krapcho M, Neyman N, Aminou R, Waldron W, et al. SEER Cancer Statistics Review, 1975–2008. National Cancer Institute; Bethesda, MD: http://seer.cancer.gov/csr/1975_2008/
    1. Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, et al. Age and acute myeloid leukemia. Blood. 2006;107(9):3481–5. - PMC - PubMed
    1. Döhner H, Estey EH, Amadori S, Appelbaum FR, Büchner T, Burnett AK, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010;115(3):453–74. - PubMed
    1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Acute myeloid leukemia. Version 2. 2011. Available from: www.nccn.org.
    1. Linenberger ML. CD33-directed therapy with gemtuzumab ozogamicin in acute myeloid leukemia: progress in understanding cytotoxicity and potential mechanisms of drug resistance. Leukemia. 2005;19(2):176–82. - PubMed

Publication types

Associated data