New Data Supports iCAD’s Xoft Brain IORT for Recurrent Glioblastoma Treatment

iCAD, Inc. has announced that new, promising clinical results supporting the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of recurrent glioblastoma (GBM), will be presented at the European Association of Neurosurgical Societies (EANS) Virtual Congress, October 19- 21, 2020.

New Data from the ongoing prospective study, entitled “Four-year experience of maximal safe resection with intraoperative balloon electronic brachytherapy for recurrent glioblastoma,” (AS-EANS-2020-00135) will be presented by Alexey Gaytan, MD, PhD, a neurosurgeon at the European Medical Center (EMC) in Moscow, Russia. The latest results demonstrate significant improvement in overall survival (OS) and local progression-free survival (locPFS) in patients with recurrent GBM treated with Xoft Intraoperative Radiotherapy (IORT) versus patients treated with external beam radiation therapy (EBRT) and systemic therapy.

“The latest results are extremely encouraging, as they underscore the potential of Xoft IORT for recurrent glioblastoma while illustrating the impact our innovative technology may have on the treatment of the most aggressive primary brain tumors,” said Michael Klein, Chairman and CEO of iCAD. “GBM has a median survival of 10-12 months^[i],[ii] and almost 297,000 cases of brain and nervous system tumors are diagnosed worldwide each year,^[iii] with inevitable recurrence; however, this data is promising and may offer hope to patients and their families.”

The study, under the guidance of Lead Investigator, Alexey Krivoshapkin, MD, PhD, a neurosurgeon at the EMC, involves 28  patients with recurrent GBM who were treated between August 2016 and June 2019. All patients underwent maximal safe resection. Researchers concluded that IORT of recurrent GBM is feasible and provides encouraging local progression-free and overall survival, with a manageable toxicity profile, and that further clinical trials are warranted.

As of May 2020, 5 patients from the IORT group were still alive, whereas none of the patients in the EBRT group survived. Our earlier release of January survival data included 7 patients surviving as of mid-December 2019. The survival of patients in the IORT group ranged from 16 – 59 months after the initial GBM diagnosis. As previously disclosed, the EBRT group survival ranged from 5.5 – 38.5 months after initial GBM diagnosis.

“We continue to be greatly encouraged by these clinical results and the benefits this treatment offers to patients with GBM,” said Professor Krivoshapkin. “There is no standard approach on how to treat patients with recurrent GBM and the repeated use of EBRT in recurrent brain tumors is often limited by a relatively high risk of radiation toxicity. Intraoperative balloon electronic brachytherapy has the potential to deliver the required prescribed single focal dose that is equivalent to multiple sessions of EBRT while minimizing radiation dose to neighboring healthy tissue.”

iCAD recently assembled a panel of experts to expand research on Xoft Brain IORT to multiple leading cancer centers worldwide. The Company is also exploring other emerging applications for the Xoft System, including the treatment of early-stage rectal tumors.

The Xoft System is a 50 kV radiation oncology treatment solution that uses a miniaturized X-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site while minimizing risk of damage to healthy tissue in nearby areas of the body. The isotope-free radiation requires minimal shielding, enabling medical professionals to remain in the room during treatment.

REFERENCES

[i]  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. 

[ii] 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/. 

[iii] 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.