Primary Brain Tumors / Metastatic Brain Tumors

Summary

The safety and performance of the GliaSite Radiation Therapy Solution (RTS) have been proven in a multi-center clinical study (Tatter, et al. J Neurosurgery. 2003). The study, sponsored by the National Cancer Institute in association with their New Approaches to Brain Tumor Therapy (NABTT) Consortium, involved patients with recurrent brain tumors. A total of 21 patients with recurrent malignant gliomas were treated with the GliaSite RTS between June 1999 and August 2000. All patients successfully underwent the GliaSite catheter implantation and radiation therapy. Complications were consistent with those reported for craniotomy. Recurrent malignant glioma patients who received treatment with GliaSite RTS demonstrated a median survival of 387 days.

Patient Demographics

Number of patients: 21

Diagnosis: Recurrent malignant glioma

Average Age: 48.4 years (± 11.3)

KPS: 80 (± 13.4)

Conclusions

• The results of this study demonstrated that implantation, brachytherapy, and explantation procedures with the GliaSite RTS are well tolerated.
• The encouraging survival data indicate that this procedure may provide benefit to patients. Median survival for all glioma patients was 387 days. For the GBM group (n=15) the median survival is 240 days and for the AA/AO (n=6) it is 537 days.
• The GliaSite RTS maximizes the patient's quality of life while delivering radiation dose to the tissue at greatest risk for recurrence.

Additional Data:

In the clinical setting, retrospective results of 80 recurrent malignant glioma patients treated with GliaSite RTS have been evaluated. Nine treatment centers contributed data including:

• University of Arizona , Tucson , AZ
• St. Luke's Medical Center , Milwaukee , WI
• Carolinas Medical Center , Charlotte , NC
• Medical University of South Carolina , Charleston , SC
• University of Pennsylvania , Philadelphia , PA
• Wake Forest University , Winston-Salem , NC
• University of Maryland , Baltimore , MD
• Medical College of Wisconsin , Milwaukee , WI
• University of Utah , Salt Lake City , UT

Patient Demographics:

• Number of Patients: 80
• Diagnosis: Recurrent malignant glioma (66 GBM and 14 AA/AO)
• Average Age: 51 years
• Karnofsky Performance Score (KPS): 80
• All patients had received previous surgery and external beam radiation with or without chemotherapy.

Results:

The overall median survival following treatment with GliaSite RTS was 267 days. Analysis of 66 GBM patients treated with surgery plus GliaSite RTS demonstrates a median survival of 36 versus 20 weeks for surgery alone.¹ The results also appear consistent with those reported in the phase II study published by Tatter et al.²

References:

1 Brem et al, Placebo controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. Lancet. 1995; 22:1008-12.

2 Tatter et al, An inflatable ballon catheter and liquid 125 I radiation source (GliaSite Radiation Therapy System) for treatment of recurrent malignant glioma: multicenter safety and feasibility trial. J Neurosurgery. 2003; 2:297-303.

3 Gabayan et al, GliaSite Brachytherapy for treatment of recurrent malognant gliomas: a retrospective multi-institutional analysis. Neurosurgery. 2006; 58(4):701-608.

For individual case studies on patients treated since completion of the clinical trial, please click on the links below:

• GliaSite RTS Treatment in Recurrent GBM *
• GliaSite RTS Treatment in Metastatic Brain Tumor *
• GliaSite RTS as Boost in Newly Diagnosed GBM *
• Outpatient GliaSite RTS Treatment in Recurrent GBM *

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