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Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma

Al's Comment:

This is a study of Temozolomide alone and in combinations with 3 different drugs that have been popular with brain tumor patients.  I think this study is too small to really tell what is happening but it is interesting for 2 things: 

1. The design of the trial is impressive - it is a new way to test multiple treatments. Great start and this is how trials should be run, but there were not enough people in each group.

2. Overall, there was no or minimal benefit to any combination tested over the Temodar alone. However, the group using isotretinoin (accutane) did much worse than all other combinations or even just Temodar alone.  This shows that trials are always needed even when it seems to make sense to try adding something to the standard therapy. IF it is strong enough to help, it is also strong enough to hurt and a trial is the only way to tell if the benefits outweigh the risks.

There have been other trials showing a benefit to adding Accutane to the standard treatment, so more research needs to be done.


Posted on: 02/13/2015

For full text go to:

neuro-oncology.oxfordjournals.org/content/17/2/266.full

Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma

 

Abstract

Background Chemoradiation, followed by adjuvant temozolomide, is the standard treatment for newly diagnosed glioblastoma. Adding other active agents may enhance treatment efficacy.

Methods The primary objective of this factorial phase II study was to determine if one of 3 potential chemotherapy agents added to dose-dense temozolomide (ddTMZ) improves progression-free survival (PFS) for patients with newly diagnosed glioblastoma. A prior phase I trial established the safety of combining ddTMZ with isotretinoin, celecoxib, and/or thalidomide. Adults with good performance status and no evidence of progression post chemoradiation were randomized into 8 arms: ddTMZ alone (7 days on/7 days off) or doublet, triplet, and quadruplet combinations with isotretinoin, celecoxib, and thalidomide.

Results The study enrolled 155 participants with a median age of 53 years (range, 18-84 y). None of the agents demonstrated improved PFS when compared with arms not containing that specific agent. There was no difference in PFS for triplet compared with doublet regimens, although a trend for improved overall survival (OS) was seen (20.1 vs 17.0 months, P= .15). Compared with ddTMZ, the ddTMZ + isotretinoin doublet had worse PFS (10.5 vs 6.5 months, P = .043) and OS (21.2 vs 11.7 months, P= .037). Trends were also seen for worse outcomes with isotretinoin-containing regimens, but there was no impact with celecoxib or thalidomide combinations. Treatment was well tolerated with expected high rates of lymphopenia.

Conclusions The results do not establish a benefit for these combinations but indicate that adding isotretinoin to ddTMZ may be detrimental. This study demonstrated the feasibility and utility of the factorial design in efficiently testing drug combinations in newly diagnosed glioblastoma.

Clinicaltrials.gov identifier NCT00112502.

 


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