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Effects of valganciclovir as an add-on therapy in patients with cytomegalovirus-positive glioblastoma: A randomised, double-blind, hypothesis-generating study.

Al's Comment:

 In the last news blast, I talked about using the anti-viral (anti CMV) Valcyte for GBMs.  Today I came across a report on a trial for Valcyte with standard therapy for GBMS.  This was a randomized trial - half get standard treatment and half get Valcyte for 6 months  in addition to standard treatment.

The trial allowed patients to stay on Valcyte after the 6 months if they wanted to and they allowed the control group to switch to Valcyte - which complicates the interpretation.. as patients who were doing well probably stayed on the valcyte while those doing poorly probably stopped... so take this as an indication that it might help - not proof..

 There was a small difference on scans but a big difference on overall survival: OS at 4 years was 27.3% in patients who used Valcyte for over 6 motnhs versus 5.9% in controls (P = 0.0466).

 


Posted on: 02/14/2013

Int J Cancer. 2013 Feb 13. doi: 10.1002/ijc.28111. [Epub ahead of print]

Effects of valganciclovir as an add-on therapy in patients with cytomegalovirus-positive glioblastoma: A randomised, double-blind, hypothesis-generating study.

Stragliotto G, Rahbar A, Solberg NW, Lilja A, Taher C, Orrego A, Bjurman B, Tammik C, Skarman P, Peredo I, Söderberg-Nauclér C.

Departments of Neurology, Center for Molecular Medicine, L8:03, Karolinska Institute, 171 76 Stockholm, Sweden.

 

Abstract

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 tumour volume (primary end point). Survival data were analysed for patients and controls in explorative analyses to aid the design of future randomised trials. Trends but no significant differences were observed in tumour volumes in Valganciclovir and placebo patients at 3 (3.58 vs 7.44 cm(3) , respectively, P = 0.2881) and 6 (3.31 vs 13.75 cm(3) , 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 randomised trials are warranted and should evaluate whether continuous antiviral treatment can improve outcome in glioblastoma patients. © 2013 Wiley Periodicals, Inc.

 

 


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