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A Phase 2 Study of Concurrent Radiation Therapy, Temozolomide, and the Histone Deacetylase Inhibitor Valproic Acid for Patients With Glioblastoma.

Al's Comment:

This is a small study - so we can't be sure the results are correct, but it seems to have minimal side effects, it can prevent seizures, and elevate mood. And it might make the Temodar and radiation work better!   May be worth trying. It is readily available.


Posted on: 07/27/2015

Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):986-92. doi: 10.1016/j.ijrobp.2015.04.038. Epub 2015 Apr 30.

A Phase 2 Study of Concurrent Radiation Therapy, Temozolomide, and the Histone Deacetylase Inhibitor Valproic Acid for Patients With Glioblastoma.

Krauze AV1, Myrehaug SD2, Chang MG3, Holdford DJ3, Smith S1, Shih J1, Tofilon PJ1, Fine HA4, Camphausen K5.
 
Author information:
1Radiation Oncology Branch, National Cancer Institute/National Institutes of Health, Bethesda, Maryland.
2Department of Radiation Oncology, Lakeridge Health Durham Regional Cancer Centre, Oshawa, Ontario, Canada.
3Massey Cancer Center Virginia Commonwealth University, Richmond, Virginia.
4New York University Langone Medical Center, New York, New York.
5Radiation Oncology Branch, National Cancer Institute/National Institutes of Health, Bethesda, Maryland. Electronic address: camphauk@mail.nih.gov.
 
Abstract
PURPOSE:
 
Valproic acid (VPA) is an antiepileptic agent with histone deacetylase inhibitor (HDACi) activity shown to sensitize glioblastoma (GBM) cells to radiation in preclinical models. We evaluated the addition of VPA to standard radiation therapy (RT) plus temozolomide (TMZ) in patients with newly diagnosed GBM.
METHODS AND MATERIALS:
 
Thirty-seven patients with newly diagnosed GBM were enrolled between July 2006 and April 2013. Patients received VPA, 25 mg/kg orally, divided into 2 daily doses concurrent with RT and TMZ. The first dose of VPA was given 1 week before the first day of RT at 10 to 15 mg/kg/day and subsequently increased up to 25 mg/kg/day over the week prior to radiation. VPA- and TMZ-related acute toxicities were evaluated using Common Toxicity Criteria version 3.0 (National Cancer Institute Cancer Therapy Evaluation Program) and Cancer Radiation Morbidity Scoring Scheme for toxicity and adverse event reporting (Radiation Therapy Oncology Group/European Organization for Research and Treatment).
RESULTS:
 
A total of 81% of patients took VPA according to protocol. Median overall survival (OS) was 29.6 months (range: 21-63.8 months), and median progression-free survival (PFS) was 10.5 months (range: 6.8-51.2 months). OS at 6, 12, and 24 months was 97%, 86%, and 56%, respectively. PFS at 6, 12, and 24 months was 70%, 43%, and 38% respectively. The most common grade 3/4 toxicities of VPA in conjunction with RT/TMZ therapy were blood and bone marrow toxicity (32%), neurological toxicity (11%), and metabolic and laboratory toxicity (8%). Younger age and class V recursive partitioning analysis (RPA) results were significant for both OS and PFS. VPA levels were not correlated with grade 3 or 4 toxicity levels.
CONCLUSIONS:
 
Addition of VPA to concurrent RT/TMZ in patients with newly diagnosed GBM was well tolerated. Additionally, VPA may result in improved outcomes compared to historical data and merits further study.
 
Published by Elsevier Inc.
PMID: 26194676 [PubMed - in process]

 


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