GliaSite Brachytherapy Research Articles

Treatment of recurrent high-grade gliomas with GliaSite brachytherapy: a prospective mono-institutional Italian experience.

The present study evaluated toxicity, local control, and survival in patients with relapsed high-grade glioma after surgery and external beam radiation therapy and treated with re-operation and GliaSite brachytherapy. Between 2006 and 2008, 15 patients with recurrent high-grade glioma underwent re-operation and GliaSite brachytherapy. Ten patients were males and 5 females. Median age was 40 years (range, 20-71). Karnofsky performance status was ≥70. All patients but one received GliaSite irradiation of the surgical cavity wall at the dose of 4500 cGy at a depth of 1 cm. No severe acute side effects were observed during GliaSite brachytherapy. Pathologically documented, symptomatic late radiation necrosis was observed in 3 patients (20%); 2 subsequently died of further complications. Two patients were alive at a median follow-up 13 months (range, 1-30). Median overall survival after GliaSite brachytherapy was 13 months. Patients with recurrent high-grade glioma can be treated with additional surgery and GliaSite brachytherapy, delivering 4500 cGy at 1 cm depth without significant acute side effects but with a significant rate (20%) of late radiation necrosis, resulting in 13% of treatment-related deaths. Compared with the literature, survival results in our study appear to be satisfactory, but they may be related to patient selection criteria. Re-intervention followed by GliaSite brachytherapy should not be offered as a standard treatment for recurrent high-grade glioma, because of the high rate of late complications, treatment-related deaths, and high treatment costs.

Treatment of recurrent high-grade gliomas with GliaSite brachytherapy: A prospective mono-institutional Italian experience

The present study evaluated toxicity, local control, and survival in patients with relapsed high-grade glioma after surgery and external beam radiation therapy and treated with re-operation and GliaSite brachytherapy. Between 2006 and 2008, 15 patients with recurrent high-grade glioma underwent re-operation and GliaSite brachytherapy. Ten patients were males and 5 females. Median age was 40 years (range, 20-71). Karnofsky performance status was ≥70. All patients but one received GliaSite irradiation of the surgical cavity wall at the dose of 4500 cGy at a depth of 1 cm. No severe acute side effects were observed during GliaSite brachytherapy. Pathologically documented, symptomatic late radiation necrosis was observed in 3 patients (20%); 2 subsequently died of further complications. Two patients were alive at a median follow-up 13 months (range, 1-30). Median overall survival after GliaSite brachytherapy was 13 months. Patients with recurrent high-grade glioma can be treated with additional surgery and GliaSite brachytherapy, delivering 4500 cGy at 1 cm depth without significant acute side effects but with a significant rate (20%) of late radiation necrosis, resulting in 13% of treatment-related deaths. Compared with the literature, survival results in our study appear to be satisfactory, but they may be related to patient selection criteria. Re-intervention followed by GliaSite brachytherapy should not be offered as a standard treatment for recurrent high-grade glioma, because of the high rate of late complications, treatment-related deaths, and high treatment costs.

Feasibility and safety of GliaSite brachytherapy in treatment of CNS tumors following neurosurgical resection

To investigate feasibility and safety of GliaSite brachytherapy for treatment of central nervous system (CNS) tumors following neurosurgical resection. We report mature results of long-term follow-up, outcomes and toxicity. In the period from 2004 to 2007, 10 consecutive adult patients with recurrent, newly diagnosed, and metastatic brain malignancies underwent GliaSite brachytherapy following maximally safe neurosurgical resection. While 6/10 (60%) patients were treated for recurrence, having previously been treated with external beam radiotherapy (EBRT), 4/10 (40%) received radiotherapy (RT) for the first time. A median dose of 52.0 Gy (range, 45.0 - 60.0 Gy) was prescribed to 0.5 cm - 1.0 cm from the balloon surface. Radiation Therapy Oncology Group (RTOG) criteria were used to assess toxicities associated with this technique. Follow-up was assessed with MRI scans and was available on all enrolled patients. Median follow-up was 38 months (range, 18 - 57 months). Mean size of GliaSite balloon was 3.4 cm (range, 2.0 - 4.0 cm). Median survival was 14.0 months for the entire cohort after the treatment. The 17.6 and 16.0 months average survival for newly diagnosed and recurrent high grade gliomas (HGG), respectively, translated into a three-month improvement in survival in patients with newly diagnosed HGG compared to historical controls (P = 0.033). There were no RTOG grades 3 or 4 acute or late toxicities. Follow-up magnetic resonance imaging (MRI) imaging did not identify radiation necrosis. Our data indicate that treatment with GliaSite brachytherapy is feasible, safe and renders acceptable local control, acute and long-term toxicities. We are embarking on testing larger numbers of patients with this treatment modality.

The role of dose escalation with intracavitary brachytherapy in the treatment of localized CNS malignancies: Outcomes and toxicities of a prospective study

Purpose This single-institution prospective study was designed to investigate the feasibility and safety of dose escalation with GliaSite (Proxima Therapeutics Inc., Alpharetta, GA) brachytherapy for the treatment of patients with newly diagnosed and recurrent central nervous system (CNS) tumors after neurosurgical resection. We now report mature results of this trial, its outcomes, and a toxicity profile. Methods and Materials Ten adult consecutive patients with recurrent and newly diagnosed CNS malignancies underwent GliaSite brachytherapy after maximally safe neurosurgical resection between 2004 and 2007. GliaSite balloon was placed intraoperatively, and the size was selected so as to conform to the surgical cavity. Low-dose-rate radiation was delivered with an aqueous solution of organically bound 125I (Iotrex: sodium 3-( 125I)-iodo-4-hydroxybenzenesulfonate; Proxima Therapeutics Inc.), introduced into the balloon portion of the device via a subcutaneous port. Two to 3 weeks later, the device was filled with Iotrex for a median dwell time of 94.3 hours (range, 68.0–120.5 hours), after which the balloon was explanted. A commercial 3-D planning system was used for a detailed analysis of dosimetry. Median dose of 52.0 Gy (range, 45.0–60.0 Gy) was prescribed 0.5–1.0 cm from the balloon surface. Radiation Therapy Oncology Group (RTOG) criteria were used to assess acute and long-term toxicities associated with this technique. Followup was assessed with MRI scans and was available on all enrolled patients. Results Median followup for surviving patients was 38 months (range, 18–57 months). Mean size of GliaSite balloon was 3.4 cm (range, 2.0–4.0 cm). Mean volume of filling was 19.0 cc (range, 4.0–35.0 cc). Median activity of Iotrex was 301.6 mCi (range, 95.0–515.4 mCi). Median survival was 14.0 months for the entire cohort after the treatment with the GliaSite device. Of our cohort, 6/10 (60%) patients sustained recurrence (20% local and 40% distant). Median time to recurrence after treatment with GliaSite was 8.0 months, and median time to death after recurrence was 7.5 months. There were no RTOG Grade 3 or 4 acute or late toxicities. Followup MRI imaging did not identify any evidence of radiation necrosis. Conclusions Our data indicate that treatment with GliaSite balloon brachytherapy is feasible and safe, while rendering acceptable local control and minimal acute and long-term toxicities for newly diagnosed and recurrent CNS malignancies. These encouraging results compel us to embark on testing larger numbers of patients with this treatment modality.

Imaging After GliaSite Brachytherapy: Prognostic MRI Indicators of Disease Control and Recurrence

In this study, we analyzed the magnetic resonance imaging (MRI) changes in patients after GliaSite treatment and characterized the prognostic MRI indicators in these patients. A total of 25 patients with recurrent glioblastoma multiforme were treated with the GliaSite Radiation Therapy System. Patients at the Johns Hopkins Hospital with recurrent glioblastoma multiforme underwent surgical resection followed by GliaSite balloon implantation. Available MRI scans for 20 patients were obtained throughout the post-GliaSite treatment course. These were reviewed and analyzed for prognostic significance. After GliaSite treatment, all patients developed some degree of T(1)-weighted contrast and T(2)-weighted hyperintensity around the resection cavity. The development of enhancement on T(1)-weighted contrast-enhanced imaging and the size of these lesions, in the absence of increasing T(2)-weighted hyperintensity, before clinical progression was not associated with decreased survival. Patients with T(1)-weighted enhancement >1 cm had a median survival of 13.6 months and those with T(1)-weighted lesions <or=1 cm had a median survival of 8.5 months (p = .014). In contrast, the development of larger areas of T(2)-weighted hyperintensity surrounding the resection cavity was significantly associated with poorer survival (p = .027). After GliaSite treatment, characteristic T(1)- and T(2)-weighted changes are seen on MRI. Greater T(1)-weighted changes in the absence of increasing edema appears not to indicate disease progression; however, greater T(2)-weighted changes were associated with decreased survival. These findings suggest that T(1)-weighted enhancement in the absence of concomitant edema after GliaSite treatment might represent pseudoprogression. Conversely, increasing T(2)-weighted hyperintensity might reflect infiltrative disease progression. These results provide a framework for the analysis of disease control in future prospective studies of GliaSite treatment.

GliaSite Brachytherapy for Treatment of Recurrent Malignant Gliomas and Metastases: A Retrospective Single-institutional Analysis

GliaSite Brachytherapy for Treatment of Recurrent Malignant Gliomas and Metastases: A Retrospective Single-institutional Analysis

Increased survival after early loading of GliaSite brachytherapy in the treatment of resected solitary brain metastases

Increased survival after early loading of GliaSite brachytherapy in the treatment of resected solitary brain metastases

Systemic iodine 125 activity after GliaSite brachytherapy: Safety considerations

Purpose After contaminated radioactive linens were detected on the completion of intracranial brachytherapy for a patient episodically incontinent of urine, the systemic absorption of iodine 125 from the GliaSite Radiation Therapy System was studied. Diffusion and leakage of 125I through the walls of the GliaSite balloon catheter have previously been reported to be negligible in both animal and human studies examining the radioactivity of urine during and after treatment. Our study estimated total systemic absorption based on activity defect measurements rather than using urinary excretion as a surrogate. Methods and materials Six patients treated with complete data were reviewed. The activity at the time of injection was compared to the activity recovered on completion of treatment after adjustment for decay. Results By comparing the activity of 125I infused with the activity recovered, 0.5–5.5% of infused 125I remained unaccounted after adjusting for decay over the 4-day treatment period. The patient with contaminated hospital linens due to urinary incontinence had unaccounted activity of 2.3%. Comparisons of the volume of liquid 125I and saline removed on completion to treatment to the volume originally instilled revealed no difference using hand-held syringes. Conclusions The systemic absorption of 125I is much greater than previously appreciated with potential clinical sequelae and safety concerns. GliaSite should be used with caution in patients incontinent of urine, and a Foley catheter should be placed to collect contaminated urine for incontinent patients.

Pulsed Reduced Dose-Rate Radiotherapy: A Novel Re-Treatment Strategy in the Management of Large Volume Recurrent Glioma

Radiotherapy delivered below standard dose-rates reduces normal tissue toxicity and can induce significant tumor regression in some tumor types. Early clinical studies suggested that fractionated reduced dose-rate external beam radiotherapy could achieve an improved therapeutic ratio. The factors and mechanisms that determine the response of normal cells and tumors to reduced dose-rate irradiation remain largely unknown. In conventional radiotherapy a dose of 2 Gy is delivered at a dose rate of 4–6 Gy/min, which means that the delivery of this dose requires only a few minutes. By reducing the effective dose-rate and increasing the treatment time, it becomes possible for repair processes to be active during irradiation. A reduced dose-rate can either be obtained by using a continuous reduced dose-rate irradiator, or by dividing the standard 2 Gy fractions into a number of equal sub-fractions that are delivered in a pulsed manner separated by a fixed time interval, allowing for repair during each sub-fraction. This is done by delivering treatment in a series of 0.2 Gy pulses separated by 3-minute time intervals, creating an apparent dose rate of 0.0667 Gy/min. We have termed this re-irradiation technique pulsed reduced dose-rate radiotherapy (PRDR). This pulsed approach will preferentially protect normal tissue and have almost the same effect in terms of tumor cell kill because repair capacity is greater in late responding normal tissues than tumors. Between January 1999 and March 2007, 99 patients with recurrent gliomas were re-irradiated using PRDR (mean dose 50 Gy) delivered in 1.8–2.0 Gy fractions. Prior to the initiation of PRDR, all patients had received conventional radiotherapy, 68 had multiple surgeries, 14 radiosurgery, 4 GliaSite brachytherapy and 78 received conventional chemotherapy and/or one or more experimental therapies. MRI-CT fusion with 3-dimensional planning was used for all patients. The treatment volume was the volume of the contrast-enhancing lesion and surrounding edema on pre-treatment MRI plus a 2 cm margin. Due to the complexities of MRI interpretation; overall survival at six months was used as the study end point. Thirty-one (31.3%) of these 99 heavily pretreated patients had an overall survival of six months or greater. There were no significant toxicities or treatment related deaths. The mean and median treatment volumes were 336 ccm and 388 ccm respectively, which is significantly larger than those reported previous re-irradiation series. Histological grading, time from initial diagnosis to the initiation of PLDR and KPS were the strongest predictors for overall survival. PRDR is a model-based methodology using reduced dose-rate external beam radiotherapy that is well tolerated and may be an effective treatment in patients with recurrent gliomas. Although the tendency is to minimize both total dose and treatment volume when re-irradiating brain tissue, our results suggest that the utilization PRDR may allow for the safe re-treatment of larger target volumes to higher doses potentially realizing a greater palliative benefit.

GliaSite Brachytherapy Boost as Part of Initial Treatment of Glioblastoma Multiforme: A Retrospective Multi-Institutional Pilot Study

To report on a retrospective analysis of the cumulative experience from eight institutions using the GliaSite Radiotherapy System as a brachytherapy boost in the initial management of glioblastoma multiforme. Eight institutions provided data on 20 patients with histologically proven glioblastoma multiforme with a median age of 59 years (range, 39-76) and median Karnofsky performance scale of 80 (range, 50-100). After maximal surgical debulking, patients were treated with GliaSite brachytherapy to a median dose of 50 Gy, followed by external beam radiotherapy to a median dose of 60 Gy (range, 46-60 Gy), for a cumulative dose escalation of 110 Gy (range, 84-130 Gy). The average survival for this study population was 11.4 months (range, 4-29). When the patients' survival was compared with that of historical controls according to their Radiation Therapy Oncology Group recursive partitioning analysis class, the average survival was increased by 3 months (95% confidence interval, 0.23-4.9) corresponding to a 43% increase (p = 0.033). Three patients (14%) experienced Radiation Therapy Oncology Group Grade 3 central nervous system toxicity. Of the treatment failures, 50% were >2 cm from the edge of the balloon. The results of this analysis have demonstrated that dose escalation (>100 Gy) with GliaSite is well tolerated and associated with minimal toxicity. Local control improved with the use of GliaSite brachytherapy. The putative survival advantage seen in this study needs to be interpreted with caution; nevertheless, the data provide sufficient justification to investigate the potential role of radiation dose escalation in conjunction with GliaSite in the initial treatment of glioblastoma multiforme.

2074: Prognostic MRI Findings and Outcomes Following Treatment of Recurrent Glioblastoma Multiforme With GliaSite Brachytherapy

2074: Prognostic MRI Findings and Outcomes Following Treatment of Recurrent Glioblastoma Multiforme With GliaSite Brachytherapy

Results of a phase II trial of the GliaSite Radiation Therapy System for the treatment of newly diagnosed, resected single brain metastases

The aim of this study was to evaluate the effectiveness of brachytherapy using the GliaSite Radiation Therapy System in patients with a newly diagnosed resected single brain metastasis. The primary end point of the study was local tumor control. The secondary end points included patient survival, distant brain recurrence, quality of life, and treatment toxicity. The authors conducted a prospective multiinstitutional phase II study of GliaSite brachytherapy prescribed at a 60-Gy dose administered to a 1-cm depth after resection of a single brain metastasis. No whole-brain radiation therapy was given. Patients were assessed at 1 and 3 months after brachytherapy and every 3 months thereafter for up to 2 years. Seventy-one patients were enrolled at 13 centers. A GliaSite balloon catheter was implanted in 62 patients. Fifty-four patients received brachytherapy. The median patient age was 60 years. The most common tumor (54%) was non-small cell lung cancer. Fifty-seven percent of patients had brain metastasis only, whereas 43% had extracranial metastasis. The median final administered dose was 60 Gy. The magnetic resonance imaging--determined local control rate, based on several different methods, was 82 to 87%. Both the median patient survival time and the median duration of functional independence were 40 weeks. Among the 35 patients who died, the cause of death was neurological in 11%. Thirteen patients underwent reoperation for suspected tumor recurrence or radiation necrosis, and histological diagnoses included radiation necrosis without tumor (nine patients), radiation necrosis mixed with tumor (two patients), and tumor only (two patients). Extracranial metastasis, tumor size, and radiation necrosis were significant factors affecting patient survival. In patients with a resected single brain metastasis, GliaSite brachytherapy leads to a local control rate, median patient survival time, and duration of functional independence similar to those achieved with resection plus whole-brain radiation therapy.

GliaSite Brachytherapy for Treatment of Recurrent Malignant Gliomas: A Retrospective Multi-institutional Analysis

To review the cumulative experience of 10 institutions in treating recurrent malignant gliomas with the brachytherapy device, GliaSite Radiation Therapy System. The patient population consisted of 95 patients with recurrent grade 3 or 4 gliomas, a median age of 51 years, and a median Karnofsky performance status score of 80. All patients had previously undergone resection and had received external beam radiotherapy as part of their initial treatment. After recurrence, each patient underwent maximal surgical debulking of their recurrent lesion and placement of an expandable balloon catheter (GliaSite) in the tumor cavity. The balloon was afterloaded with liquid I (Iotrex) to deliver a median dose of 60 Gy to an average depth of 1 cm with a median dose rate of 52.3 Gy/hr. Patients were carefully followed with serial magnetic resonance imaging and monthly examinations for tumor progression, side effects, and survival. The median survival for all patients, measured from date of GliaSite placement, was 36.3 weeks with an estimated 1 year survival of 31.1%. The median survival was 35.9 weeks for patients with an initial diagnosis of glioblastoma multiforme and 43.6 weeks for those with non- glioblastoma multiforme malignant gliomas. Analysis of the influence of various individual prognostic factors on patient survival demonstrated that only Karnofsky performance status significantly predicted for improved survival. There were three cases of pathologically documented radiation necrosis. Reirradiation of malignant gliomas with the GliaSite Radiation Therapy System after reresection seems to provide a modest survival benefit above what would be expected from surgery alone. This report not only confirms the initial results of the feasibility study but provides evidence that similar outcomes can be obtained outside of a clinical trial.

Treatment of recurrent glioblastoma multiforme with GliaSite brachytherapy

In this study, we assess the efficacy of GliaSite brachytherapy in the treatment of patients with recurrent glioblastoma multiforme (GBM). Between 1999 and 2004, 24 patients with recurrent glioblastoma multiforme were treated with the GliaSite Radiation Therapy System (RTS). The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of surgical resection. Low-dose-rate radiation is then delivered locally by temporarily inflating the balloon with an aqueous solution of organically bound (125)I (Iotrex [sodium 3-((125)I)-iodo-4-hydroxybenzenesulfonate]). Patients at the Johns Hopkins Hospital with recurrent GBM, who were previously treated with surgery and external beam radiotherapy, underwent surgical resection followed by GliaSite balloon implantation. Subsequently, the patients received radiation therapy using the GliaSite to a mean dose of 53.1 Gy. Ten patients were male, and 14 patients were female. The mean age was 48.1 years. All patients had pathologically confirmed recurrent GBM. The median Karnofsky performance status (KPS) was 80. Median follow-up time was 21.8 months. At the time of analysis, 18 patients (75%) had died; 6 patients (25%) were alive. Median survival from diagnosis for all patients was 23.3 months. Median survival after GliaSite brachytherapy was 9.1 months. Patients with a KPS > or =70 had a median survival of 9.3 months, whereas patients with a KPS <70 had a median survival of 3.1 months (p < 0.003). Survival was not significantly different between patients receiving 45 Gy and patients receiving a dose greater than 45 Gy. Acute side effects were minor, consisting of mild nausea and/or headache. One patient developed a wound infection. No incidents of meningitis were observed. Late sequelae were rare, but 2 incidents of symptomatic radiation necrosis were observed. One patient developed transient expressive aphasia. GliaSite radiotherapy confers a prolongation of survival in patients with recurrent glioblastoma multiforme compared to historical controls with recurrent GBM. GliaSite therapy leads to a favorable survival outcome of 9.3 months in patients with KPS > or =70, but only 3.1 months in patients with KPS <70. Favorable survival is observed for patients within each recursive partitioning analysis class. Treatment with GliaSite is safe and generally well tolerated. Additional data are needed to fully assess the therapeutic benefit of GliaSite brachytherapy for recurrent GBM.

NABTT 2105: A phase I dose-escalation trial of GliaSite brachytherapy with conventional radiation therapy for newly diagnosed glioblastoma multiforme

1570 Background: NABTT opened trial 2105 to determine the maximum tolerated dose (MTD) of GliaSite Brachytherapy (GSBT) with external beam radiation therapy (EBRT) in the treatment of newly-diagnosed GBM (NDGBM). Methods: Patients were enrolled in cohorts of 5 and received postoperative GSBT followed by conventional EBRT to 46 Gy +14 Gy boost. EBRT began within 30 days after GSBT, but not more than 60 days post surgery. A DLT was defined as CTC 2.0 grade 3/4 toxicity not resolved within 1 month of onset or 3 months from end of GSBT (whichever was longer), any Grade 5 toxicity, or radiation necrosis requiring craniotomy within 3 months from completion of brachytherapy. Progressive disease (PD) was defined as progressive neurologic abnormalities not explained by causes unrelated to tumor progression; > 25% increase in the volume of enhancing tumor; or new enhancement on MRI. Results: 13 patients were screened. 10 were treated with GSBT of which 8 were replaced: 5 had imaging progression before the evaluation endpoint was reached; 1 died of PE; 1 was taken off study to start new therapy; and 1 received incorrect dose of GSBT. The median patient age was 57 years (27–68); median KPS was 90 (60–100); median balloon size was 3 cm (2–4); median GSBT dose was 70 Gy at 1 cm depth (53–70); median dwell time was 95 hrs (92–165); and median delivered radioactivity was 365 mCi (195–419). No DLT was encountered. 6 patients were alive at last follow up. The median time of survival will be presented as data mature. Conclusions: As a significant number of patients did not reach the evaluation endpoint, it was determined that this trial could not be completed. Analysis of the MRIs suggested that radiographic changes may have represented treatment response and not PD. Phase III EORTC trial data showed that patients with NDGBM should be treated with concomitant temozolomide. It was therefore decided to close the trial and replace it with a Phase II trial using fixed-dose GSBT with temozolomide, the goal being to characterize the associated imaging changes and correlate these with pathologic findings at the time of imaging progression. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Proxima Therapeutics Proxima Therapeutics

A phase I dose-escalation trial of GliaSite brachytherapy for recurrent glioblastoma multiforme

1548 Background: NABTT opened trial 2106 to determine the maximum tolerated dose (MTD) of GliaSite Brachytherapy (GSBT) in the treatment of recurrent GBM. This trial closed 2004 without reaching the MTD. Methods: Patients with recurrent resectable GBM were enrolled in cohorts of 5 to receive postoperative brachytherapy. A DLT was defined as CTC 2.0 grade 3/4 toxicity not resolved within 1 month of onset or 3 months from end of brachytherapy (whichever was longer), any Grade 5 toxicity, or radiation necrosis requiring craniotomy within 3 months from completion of brachytherapy. Progressive disease (PD) was defined as progressive neurologic abnormalities not explained by causes unrelated to tumor progression; greater than 25% increase in the volume of enhancing tumor; or new enhancement on MRI scan. Results: 12 patients were screened. 7 did not receive GSBT. Of the remaining 5, 1 was taken off study prior to the evaluation endpoint to start new therapy.The median patient age was 56 years (43–67). The median KPS was 90 (60–100). 3 patients had a diagnosis of GBM (WHO IV), 1 had AA (WHO III) and 1 had AO (WHO III). The median number of cycles of previous chemotherapy was 3 (1–6). The median previous external beam radiation therapy dose was 60 Gy (56–63). The median balloon size was 3.0 cm (2.0–4.0). All patients received a dose of 80 Gy @ 1 cm. The median dwell time 116 hrs (115–168). The median delivered radioactivity was 429 mCi (237–661). No DLT was encountered. At the endpoint, 2 had SD, and 2 had PD. The patient taken off study to start a new treatment had a PR. 2 patients were alive at last follow up. The median time of survival will be presented as the data mature. Conclusions: At this time, it was determined that this trial could not complete accrual. Analysis of the early PD suggested that some of the radiographic findings may have represented a reaction to treatment. It was thus decided that the trial would be closed and replaced by a Phase II trial using a fixed dose of GSBT with an endpoint designed to characterize the imaging changes associated with GSBT and correlate these with biologic and pathologic findings at the time of imaging progression. No significant financial relationships to disclose.

Treatment of recurrent glioblastoma multiforme with GliaSite brachytherapy

1544 Background: Glioblastoma multiforme is a primary malignancy of the central nervous system that is fatal despite treatment with surgery and standard adjuvant therapy. Long-term control of these tumors is rarely achieved and GBM frequently recurs. In this study, we assess the efficacy of GliaSite brachytherapy in the treatment of patients with recurrent glioblastoma multiforme (GBM). Methods: Between 1999 and 2004, twenty-four patients with recurrent glioblastoma multiforme were treated with the GliaSite Radiation Therapy System (RTS). The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of surgical resection. Low-dose rate radiation is then delivered locally by temporarily inflating the balloon with an aqueous solution of organically bound I-125 (Iotrex [sodium 3-(I-125)-iodo-4-hydroxybenzenesulfonate]). Patients at the Johns Hopkins Hospital with recurrent GBM underwent surgical reresection followed by GliaSite balloon implantation. Subsequently, the patients received radiation therapy using the GliaSite to a mean dose of 53.1 Gy. The mean age was 48.1 years. The median Karnofsky performance status (KPS) was 80. Median followup time was 21.8 months. Results: At the time of analysis, 18 patients (75%) had died; 6 patients (25%) were alive. Median survival from diagnosis for all patients was 23.3 months. Median survival after GliaSite brachytherapy was 9.1 months. Patients with a KPS ≥ 70 had a median survival of 9.3 months while patients with a KPS < 70 had a median survival of 3.1 months (p<0.003). Survival was not significantly different between patients receiving 45 Gy and patients receiving a dose greater than 45 Gy. Acute side effects and late sequelae were rare. Conclusions: GliaSite radiotherapy confers a prolongation of survival in patients with recurrent glioblastoma multiforme compared to historical controls with recurrent GBM. GliaSite therapy leads to a favorable survival outcome of 9.3 months in patients with KPS ≥ 70, but only 3.1 months in patients with KPS < 70. Favorable survival is observed for patients within each recursive partitioning analysis (RPA) class. Treatment with GliaSite is safe and generally well tolerated. No significant financial relationships to disclose.

Interim results of a Phase II study of resection and GliaSite brachytherapy for a single brain metastasis

Interim results of a Phase II study of resection and GliaSite brachytherapy for a single brain metastasis

Interim results of a Phase II study of resection and GliaSite brachytherapy for a single brain metastasis

Interim results of a Phase II study of resection and GliaSite brachytherapy for a single brain metastasis

Recurrent primary fibrosarcoma of the brain treated with the gliasite brachytherapy system: case report

Background Primary brain sarcomas are rarely curable with surgery and standard radiation therapy. They typically recur locally within 6 months of treatment. This case report describes a novel treatment approach for primary or recurrent brain sarcomas with intracavitary brachytherapy. Case description This 34-year-old female presented with a large and rapidly recurrent primary fibrosarcoma in the right fronto-parietal brain only 1 month postinitial total resection. She was reoperated, again with an MRI-documented gross total resection, but at this second surgery a GliaSite RTS (a recently FDA-approved balloon catheter system for intracranial intracavitary brachytherapy) was inserted into the surgical cavity. Over four days a radiation dose of 152 Gy was delivered at the balloon surface dose and 50.0Gy was delivered at a depth of 7 mm from balloon surface. The patient received subsequent treatment with external beam radiation and chemotherapy. The patient tolerated her treatment well and has shown no evidence of tumor recurrence with a follow up of 18 months. Conclusion Boost intracavitary brachytherapy can play a critical role in preventing local recurrence and early death in patients with primary brain sarcomas.