GliaSite RTS Information Request
Clinical Data

Primary Brain Tumors / Metastatic Brain Tumors

Summary

Results from a multi-center, prospective study in patients with a solitary brain metastasis show that GliaSite Radiation Therapy System (RTS) following surgical removal of the tumor is a beneficial and well-tolerated treatment option. Local control of the tumor was 87% with GliaSite RTS and quality of life was maintained.1-2

Thirteen centers participated in the study including:

  • Carolinas Medical Center
  • Cleveland Clinic
  • Emory University
  • H. Lee Moffit Cancer Center
  • Henry Ford Hospital
  • MD Anderson
  • Semmes-Murphey Clinic
  • University of Iowa
  • University of North Carolina
  • University of Pennsylvania
  • University of Utah
  • Wake Forest University
  • Yale University

Patient Demographics

Number of patients treated: 54

Diagnosis: metastatic carcinoma

Average Age: 60 years (range 29-86 years)

Average Karnofsky Performance Score: 90 (range 70-100)

Results

Tumor Control
•  Local Control – 87%
•  Median local control time was >66 weeks.
•  Distant Control – 56%
•  Median distant control time was 54 weeks.

Survival is consistent with other treatment modalities.
•  Median survival was 40 weeks.
•  11% of deaths classified as Central Nervous System (CNS) related.

Toxicity
•  The safety profile was comparable to this patient population following craniotomy.
•  Reoperation for radiation necrosis occurred in 9 patients at 14-79 weeks.
•  Two additional patients were determined to have mixed tumor and radiation necrosis.

Steroid Administration
•  Steroid administration in this study was comparable to use in this patient population.

Quality of Life
•  Median duration of functional independence was 53 weeks.
•  Median KPS at one year was 80.

Conclusions

•  The encouraging tumor control and quality of life data indicate that GliaSite may provide benefit to patients.
•  GliaSite RTS should be considered for patients undergoing surgical resection.
•  This local radiation treatment allows for delay of WBRT.

References:

1 Rogers et al, Interim results of a phase II study of resection and GliaSite brachytherapy for a single brain metastasis. Presented at the Congress of Neurological Surgeons Meeting, October 2004.

2 Patchell RA, Tibbs PA, Regine WF, Dempsey RJ, Mohiuddin M, et al. Postoperative radiotherapy in the treatment of single metastases to the brain: a randomized trial. Journal of the American Medical Association (JAMA) 280:1485-1489, 1998.

GliaSite Healthcare Professionals
Quick Facts
"This modality is appealing because of the high spatial localization of the dose and the favorable therapeutic ratio afforded by the continuous administration of radiation at a low dose rate spares normal brain tissue from adverse radiation effects."
(Tatter et al., J Neurosurgery, 2003)

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