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Hematologic improvement and response in elderly AML/RAEB patients treated with valproic acid and low-dose Ara-C.

Abstract
The histone deacetylase inhibitor (HDACi) valproic acid (VPA) has been shown to be active on acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB). Thirty-one elderly AML/RAEB patients (AML n=25; RAEB n=6) with a high rate of comorbidity were entered in a phase II study with low-dose cytarabine (Ara-C) and VPA. Fitness was evaluated by means of the Comprehensive Geriatric Assessment (CGA), including the Cumulative Illness Rating Scale (CIRS) score, the self-sufficiency scores of Activity of Daily Living (ADL) and Instrumental Activity of Daily Living (IADL). Eight patients obtained a lasting complete remission and 3 other patients obtained hematologic improvement for a total response rate of 35%. Five of 11 responding patients were relapsed or resistant after a previous treatment with Ara-C. Seven of 11 responding patients were assessed as frail at enrollment and/or had IADL impairment. Grades 3 and 4 toxicities were mainly hematological. Low-dose Ara-C and VPA is a relatively non-toxic combination with good therapeutic activity in elderly patients with AML/RAEB. This therapeutic approach represents an alternative treatment for patients who cannot undergo standard induction therapy.
AuthorsM T Corsetti, F Salvi, S Perticone, A Baraldi, L De Paoli, S Gatto, D Pietrasanta, M Pini, V Primon, F Zallio, A Tonso, M G Alvaro, G Ciravegna, A Levis
JournalLeukemia research (Leuk Res) Vol. 35 Issue 8 Pg. 991-7 (Aug 2011) ISSN: 1873-5835 [Electronic] England
PMID21474179 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011. Published by Elsevier Ltd.
Chemical References
  • Anticonvulsants
  • Antimetabolites, Antineoplastic
  • Cytarabine
  • Valproic Acid
Topics
  • Aged
  • Aged, 80 and over
  • Anemia, Refractory, with Excess of Blasts (drug therapy, genetics, pathology)
  • Anticonvulsants (therapeutic use)
  • Antimetabolites, Antineoplastic (therapeutic use)
  • Cytarabine (therapeutic use)
  • Drug Therapy, Combination
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • In Situ Hybridization, Fluorescence
  • Leukemia, Myeloid, Acute (drug therapy, genetics, pathology)
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy, genetics, pathology)
  • Remission Induction
  • Survival Rate
  • Treatment Outcome
  • Valproic Acid (therapeutic use)

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