|
|
An inflatable balloon catheter and liquid 125I
radiation source (GliaSite Radiation Therapy System) for treatment of recurrent
malignant glioma: multicenter safety and feasibility trial
Tatter SB, Shaw EG, Rosenblum ML, Karvelis KC, Kleinberg L, Weingart
J, Olson JJ, Crocker IR, Brem S, Pearlman JL, Fisher JD, Carson K, Grossman SA;
New Approaches to Brain Tumor Therapy Central Nervous System Consortium
Department of Neurosurgery, Wake Forest University,
Winston-Salem, North Carolina, USA.
jfisher@jhmi.edu.
Object. In this study the authors evaluated the safety and performance of
the GliaSite Radiation Therapy System (RTS) in patients with recurrent malignant
brain tumors who were undergoing tumor resection.
Methods. The GliaSite is an inflatable balloon catheter
that is placed in the resection cavity at the time of tumor debulking.
Low-dose-rate radiation is delivered with an aqueous solution of organically
bound iodine-125 (lotrex [sodium 3-(125I)-iodo-4-hydroxybenzenesulfonate]),
which are temporarily introduced into the balloon portion of the device via a
subcutaneous port.
Adults with recurrent malignant glioma underwent resection and GliaSite
implantation.
One to 2 weeks later, the device was filled with Iotrex for 3 to 6 days,
following which the device was explanted.
Twenty-one patients with recurrent high-grade astrocytomas were enrolled in the
study and received radiation therapy.
There were two end points:
1) successful implantation and delivery of brachytherapy; and
2) safety of the device.
Implantation of the device, delivery of radiation, and the explantation
procedure were well tolerated.
At least 40 to 60 Gy was delivered to all tissues within the target
volume.
There were no serious adverse device-related events during brachytherapy.
One patient had a pseudomeningocele, one patient had a wound infection, and
three patients had meningitis (one bacterial, one chemical, and one
aseptic).
No symptomatic radiation necrosis was identified during 21.8 patient-years of
follow up.
The median survival of previously treated patients was 12.7 months (95%
confidence interval 6.9-15.3 months).
Conclusions. The GliaSite RTS performs safely and
efficiently.
It delivers a readily quantifiable dose of radiation to tissue at the highest
risk for tumor recurrence.
PMID: 12924704 [PubMed - in process]
Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12924704&dopt=Abstract |
