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Placebo-controlled
trial of safety and efficacy of intraoperative controlled delivery by
biodegradable polymers of chemotherapy for recurrent gliomas.
The Polymer-brain
Tumor Treatment Group
Brem
H, Piantadosi S, Burger PC, Walker M, Selker R, Vick NA, Black K, Sisti M, Brem
S, Mohr G, et al.
Department
of Neurological Surgery, John Hopkins University School of Medicine, Baltimore,
Maryland 21205, USA
Chemotherapy
for brain tumours has been limited because of difficulty in achieving adequate
exposure to the tumour without systemic toxicity.
We have developed a method for
local sustained release of chemotherapeutic agents by their incorporation into
biodegradable polymers. Implantation of the drug-impregnated polymer at the
tumour site allows prolonged local exposure with minimal systemic exposure.
We
conducted a randomised, placebo-controlled, prospective study to evaluate the
effectiveness of biodegradable polymers impregnated with carmustine to treat
recurrent malignant gliomas.
In 27 medical centres, 222 patients with recurrent
malignant brain tumours requiring re-operation were randomly assigned to receive
surgically implanted biodegradable polymer discs with or without 3.85%
carmustine.
Randomisation balanced the treatment groups for all of the
prognostic factors examined.
Median survival of the 110 patients who received
carmustine polymers was 31 weeks compared with 23 weeks for the 112 patients who
received only placebo polymers (hazard ratio = 0.67, p = 0.006, after accounting
for the effects of prognostic factors).
Among patients with glioblastoma,
6-month survival in those treated with carmustine-polymer discs was 50% greater
than in those treated with placebo (mortality = 32 of 72 [44%] vs 47 of 73
[64%], p = 0.02).
There were no clinically important adverse reactions related
to the carmustine polymer, either in the brain or systemically. Interstitial
chemotherapy delivered with polymers directly to brain tumours at the time of
surgery seems to be a safe and effective treatment for recurrent malignant
gliomas.
PMID:
7723496 [PubMed - indexed for MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7723496&dopt=Abstract |
