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Interstitial
chemotherapy with carmustine-loaded polymers for high-grade gliomas: a
randomized double-blind study
Valtonen S, Timonen U, Toivanen P, Kalimo H, Kivipelto L, Heiskanen O,
Unsgaard G, Kuurne T
Department of Neurosurgery, Turku University Central
Hospital, Finland
Objective. To find out the effect of carmustine (bischloroethyl-nitrosourea)
combined with a biodegradable polymer in the treatment of malignant (Grades III
and IV) gliomas, applied locally, at the time of the primary operation.
Methods. Prospective, randomized double-blind study of an active
treatment group versus a placebo group.
Conducted at the Departments of Neurosurgery of the University Hospitals of
Helsinki, Tampere, and Turku in Finland and Trondheim in Norway.
The study consisted of 32 patients (16 in each treatment group) enrolled between
March 23, 1992, and March 19, 1993.
The study was planned to include 100 patients but had to be terminated
prematurely, because the drug that was being used had become unobtainable.
The main outcome measures included the survival times of patients after the
operations and the application of an active drug or placebo.
Results. The median time from surgery to death was 58.1 weeks for the
active treatment group versus 39.9 weeks for the placebo group (P = 0.012).
For 27 patients with Grade IV tumors, the corresponding times were 39.9 weeks
for the placebo group and 53.3 weeks for the active treatment group (P = 0.008).
At the end of the study, six patients were still alive, five of whom belonged to
the active treatment group.
Conclusion. Carmustine applied locally in a biodegradable polymer at the
time of primary operation, seems to have a favorable effect on the life span of
patients with high-grade gliomas.
PMID:
9218294 [PubMed - indexed for MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9218294&dopt=Abstract |
