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Phase
II study of thalidomide in the treatment of recurrent glioblastoma multiforme
Marx GM, Pavlakis N, McCowatt S, Boyle FM, Levi JA, Bell DR, Cook R, Biggs M,
Little N, Wheeler HR
Royal North Shore Hospital, University of Sydney,
Australia
Treatment options and prognosis remains poor for patients with recurrent
glioblastoma multiforme.
These tumors are highly vascularised and over express
angiogenic factors such as vascular endothelial growth factor and may
potentially be responsive to antiangiogenic therapies.
We present the results of
a phase II trial of Thalidomide, an antiangiogenic agent, in the treatment of
recurrent glioblastoma multiforme.
Patients were treated with 100 mg/day of
Thalidomide, increased at weekly intervals by 100 mg to a maximum tolerated dose
of 500 mg/d.
Forty-two patients were enrolled, with 38 patients being assessable
for response and 39 for toxicity.
Two patients (5%) achieved a partial response
and 16 (42%) had stable disease.
The median survival was 31 weeks and the 1-year
survival was 35%.
Patients who had a partial response or stable disease had
either a stabilisation or improvement in quality of life scores or performance
status.
Overall Thalidomide was well tolerated with no grade 4 toxicities and no
treatment related deaths.
The median maximum tolerated dose was 300 mg/day.
The
most common toxicity was fatigue to which patients developed tachyphylaxis.
There was no correlation demonstrated with plasma vascular endothelial growth
factor levels and response or survival.
Thalidomide is a well-tolerated drug
that may have some activity in the treatment of recurrent glioblastoma.
Optimum
dosing with antiangiogenic agents is currently under investigation.
Chronic low
dose therapy may be required to see conventional responses or improvements in
time to progression.
The dose required to achieve optimal biological impact may
be better defined once we have established reliable surrogate endpoints.
PMID: 11763420 [PubMed - indexed for MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11763420&dopt=Abstract
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