Brain IORT
Brain Tumor Treatment with Xoft IORT | Intraoperative Radiation Therapy
Worldwide, almost 297,000 cases of brain and nervous system tumors are diagnosed per year.1 Glioblastoma (GBM) is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months. Treatment for brain tumors typically involves surgical removal, followed by radiation therapy or chemotherapy.2,3
Xoft brain IORT is a promising treatment option that may offer better outcomes for patients, with minimal side effects, compared to traditional radiation therapy. For the treatment of certain types of brain tumors, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of post-operative external beam radiation therapy (EBRT) with a single fraction of radiation.
IORT with the Xoft System allows radiation oncologists and surgeons to work together to deliver a full course of radiation treatment in one day, at the time of surgery, while the patient is under anesthesia. Once the tumor has been surgically removed, the Xoft System’s miniature x-ray source is inserted inside a flexible balloon-shaped applicator, which is then placed inside the tumor cavity, filled with saline, and used to deliver a single dose of radiation directly to the tumor bed.
The Xoft System is FDA cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It is supported by a growing body of evidence for the treatment of early-stage breast cancer, non-melanoma skin cancer (NMSC), gynecological cancers and brain cancers.
IORT: Can a New Multidisciplinary Approach Make a Difference in Treating Brain Tumors?
Join us for a free virtual roundtable discussion featuring leading experts in Neuro-oncology who will share how intraoperative radiation therapy (IORT) is emerging as a multidisciplinary approach for the treatment of brain tumors.
Featured Panelists
Michael Howard, PhD DABMP RSODirector of Oncology Services, Chief of Medical Physics, Sarah Cannon Cancer Institute, Parkridge Medical Center, HCA HealthcareAlexey Krivoshapkin, PhDHead of Neurosurgery branch of Neurology and Neurosurgery School, MD, Professor, Neurosurgeon at the European Medical Center in Moscow, RussiaDr. Santosh Kesari MD, PhDDirector of Neuro-oncology Chair and Professor, Department of Translational Neurosciences at Saint John's Cancer Institute in Santa Monica, CA
Advantages of the Xoft System
The inflatable balloon provides a minimally invasive approach, fast procedure implementation, and an easy workflowOptimized adherence of the inflated balloon to the resected cavity50 kV System allows a significant sparing of the healthy tissue prone to dose escalation and longer OS and loc PFS in patients with GBM relapse
Brain IORT with the Xoft System is a groundbreaking procedure that has potential to extend lives and address a significant unmet need in the treatment of several types of cancers including metastatic brain tumors and GBM.
Xoft Intraoperative Radiation Therapy (IORT) for Brain Cancer: Local Tumor Control in Patients with Recurrent Glioblastoma
Join Professor Krivoshapkin & Dr. Gaytan for an informative product showcase discussing Neuro IORT and the benefits it offers to physicians, facilities and patients.
Learn more about the the promising preliminary results of IORT for Brain Cancer
Featuring Alexey Krivoshapkin, MD, PhD
Professor, Head of Neurosurgery branch of Neurology and Neurosurgery School
Neurosurgeon at the European Medical Center in Moscow, Russia
Supporting Clinical Research
The Xoft System is currently being studied for the treatment of multiple types of brain tumors in leading institutions worldwide. Following please find details of ongoing research:
- Researchers at the European Medical Center (EMC) in Moscow, one of the largest private medical clinics in Russia and an international leader in comprehensive care and oncology, are researching Xoft brain IORT for the treatment of recurrent glioblastoma multiforme (GBM). In a matched pair study, a total of 30 patients were treated with recurrent GBM between August 2016 and June 2019. All patients underwent maximal safe resection; patients were divided into IORT and EBRT groups. The IORT group (A) was treated with a single fraction of radiation immediately following surgical resection, without chemotherapy or temozolomide following surgery. The comparison group (B) was treated with routine postoperative adjuvant chemotherapy +/- concomitant or sequential EBRT.
- According to positive clinical research submitted to the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program in May 2020 by Nidal Salim, MD, radiation oncologist and head of the radiotherapy center at the EMC, median overall survival (OS) was 27 months in the IORT group, versus 21 months in the EBRT group. The local progression free survival (locPFS) range for the IORT group was between 3.5 to 39 months, versus 2 to 10 months in the EBRT group. As of December 2019, 8 patients were alive out of the IORT group, whereas none of the patients of the EBRT group survived. This research will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.
- Positive preliminary clinical data on Xoft IORT were presented at the European Association of Neurosurgical Societies (EANS) Congress in Dublin, Ireland in September 2019 by Alexey Gaytan, MD, PhD, neurosurgeon at the EMC. Median overall survival (OS) in the IORT group was 24 months; OS for the EBRT group was 21 months. As of September 2019, nine patients were still alive from the IORT group, whereas none of the patients from the EBRT group survived.
- Researchers at the James Graham Brown Cancer Center at the University of Louisville are currently conducting a clinical trial on IORT for patients with large brain metastases treated with neurological resection with the Xoft System. In February 2020, the first metastatic brain tumor was treated in the U.S. with intraoperative radiation therapy (IORT) using the Xoft System at this facility.4
- A retrospective analysis published in World Neurosurgery by Alexey Krivoshapkin, MD, PhD, et al. examined the repeat resection and the various methods of IORT for the treatment of malignant brain gliomas (MBGs), including high-energy linear accelerators and modern, integrated brachytherapy solutions using solid and balloon applicators.5 The findings from this review showed IORT with balloon applicators to be particularly promising.
iCAD Announces Renowned Neuro-Oncologist Santosh Kesari, MD, PhD to Lead Post-Market Study for Treatment of Recurrent Glioblastoma (GBM) with FDA-cleared Xoft Brain IORT Technology to Support Clinical Adoption
Read More at Clinicaltrials.gov
The “GLIOX” Trial
Phase II Study of Patients With Recurrent Glioblastoma Multiforme Treated With Maximal Safe Neurosurgical Resection and Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab
Additional indications under
investigation include prostate, pancreatic,
and colorectal cancers.
For more information or to discuss participation in the Xoft Clinical Publication Support Program, please complete the form and we will contact you shortly.
References:
1. WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2018. Accessed via https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
2. Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK470003.
3. Pan E, Prados MD. Glioblastoma Multiforme and Anaplastic Astrocytoma. In: Kufe DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC Decker; 2003. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK12526/.
4. University of Louisville. Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection. Accessed via https://clinicaltrials.gov/ct2/show/NCT04040400. ClinicalTrials.gov Identifier: NCT04040400.
5. Krivoshapkin A, et al. Repeat Resection and Intraoperative Radiotherapy for Malignant Gliomas of the Brain: A History and Review of Current Techniques. World Neurosurgery (2019) 132: 356-362. Accessed via https://doi.org/10.1016/j.wneu.2019.09.037.
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