Document Detail

Effects of valganciclovir as an add-on therapy in patients with cytomegalovirus-positive glioblastoma: a randomized, double-blind, hypothesis-generating study.
MedLine Citation:
PMID:  23404447     Owner:  NLM     Status:  MEDLINE    
Cytomegalovirus is highly prevalent in glioblastomas. In 2006, we initiated a randomized, double-blind, placebo-controlled, hypothesis-generating study to examine the safety and potential efficacy of Valganciclovir as an add-on therapy for glioblastoma. Forty-two glioblastoma patients were randomized in double-blind fashion to receive Valganciclovir or placebo in addition to standard therapy for 6 months. Magnetic resonance images were obtained before and immediately and 3 and 6 months after surgery to evaluate treatment efficacy by measuring contrast enhancing tumor volume (primary end point). Survival data were analyzed for patients and controls in explorative analyses to aid the design of future randomized trials. Trends but no significant differences were observed in tumor volumes in Valganciclovir and placebo patients at 3 (3.58 vs. 7.44 cm3, respectively, p = 0.2881) and 6 (3.31 vs. 13.75 cm3, p = 0.2120) months. Median overall survival (OS) was similar in both groups (17.9 vs. 17.4 months, p = 0.430). Patients could take Valganciclovir for compassionate use after the study phase. Explorative analyses showed an OS of 24.1 months (95% CI, 17.4-40.3) in patients receiving >6 months of Valganciclovir (Val > 6M) versus 13.1 months (95% CI, 7.9-17.7, p < 0.0001) in patients receiving Valganciclovir for 0 or <6 months, and 13.7 months (95% CI, 6.9-17.3, p = 0.0031) in contemporary controls. OS at 4 years was 27.3% in Val>6M patients versus 5.9% in controls (p = 0.0466). Prolonged OS in Val>6M patients suggest that future randomized trials are warranted and should evaluate whether continuous antiviral treatment can improve outcome in glioblastoma patients.
Giuseppe Stragliotto; Afsar Rahbar; Nina Wolmer Solberg; Anders Lilja; Chato Taher; Abiel Orrego; Birgitta Bjurman; Charlotte Tammik; Petra Skarman; Inti Peredo; Cecilia Söderberg-Nauclér
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-03-13
Journal Detail:
Title:  International journal of cancer. Journal international du cancer     Volume:  133     ISSN:  1097-0215     ISO Abbreviation:  Int. J. Cancer     Publication Date:  2013 Sep 
Date Detail:
Created Date:  2013-08-02     Completed Date:  2013-10-23     Revised Date:  2014-05-22    
Medline Journal Info:
Nlm Unique ID:  0042124     Medline TA:  Int J Cancer     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1204-13     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 UICC.
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MeSH Terms
Antiviral Agents / therapeutic use*
Brain Neoplasms / mortality,  virology*
Cytomegalovirus / drug effects*
Double-Blind Method
Ganciclovir / adverse effects,  analogs & derivatives*,  therapeutic use
Glioblastoma / mortality,  virology*
Middle Aged
Reg. No./Substance:
0/Antiviral Agents; 0/valganciclovir; P9G3CKZ4P5/Ganciclovir
Comment In:
Neurosurgery. 2014 Feb;74(2):N23-4   [PMID:  24435151 ]
Int J Cancer. 2014 Jul 1;135(1):248-9   [PMID:  24338548 ]
Int J Cancer. 2014 Jul 1;135(1):250-1   [PMID:  24338590 ]

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