Xoft has presented 12 month follow-up data for isotope-free breast intraoperative radiation therapy (IORT). The company said that the utilization of the FDA cleared Axxent Electronic Brachytherapy, eBx, System to deliver IORT is growing as clinical experience demonstrates the isotope-free cancer treatment platform is a patient and physician friendly alternative.
Reportedly, in the study, ‘Twelve-Month Follow-Up Results of a Trial Utilizing Xoft Axxent Electronic Brachytherapy to Deliver Intraoperative Radiation Therapy for the Early Stage Breast Cancer,’ researchers enrolled 11 patients in an IRB approved IORT treatment protocol and reported oncologic, cosmetic and mammographic outcomes at one year post-IORT.
Xoft said that the 12-month results suggest that IORT utilizing Xoft’s Electronic Brachytherapy is emerging as a patient and physician friendly alternative to Whole Radiation Therapy (WBRT) as well as APBI in a selected group of patients with early breast cancer.
IORT is a radiation therapy technique where a concentrated dose of radiation is delivered to a cancerous tumor site during surgery after the tumor is removed. For breast IORT, the shorter treatment time is generally more convenient for patients than the seven-week course of external beam-therapy, and may increase patient compliance.
The Xoft eBx System uses a miniaturized X-ray source instead of a radioactive isotope to deliver radiation to the breast from within a balloon catheter. The low energy and rapid dose fall-off of the electronic source permit treatment in typical operating rooms, with minimal shielding required. Lightweight and mobile, the system can be moved easily between multiple ORs.
Xoft said that available for treatment of early stage breast cancer, endometrial cancer, and skin cancer, the Axxent eBx System is also FDA-cleared for IORT. As a platform technology, the Axxent System is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue.
Utilizing a miniaturized X-ray source and robotic controller, the system can be used to deliver radiation in minimally shielded therapeutic settings. Treatment can be performed without the need for a shielded room, allowing the radiation oncologist and other medical personnel to be present during treatment delivery which minimizes patient anxiety.
Michael Klein, president and CEO of Xoft, said: “We are very pleased with the strong interest in and growing adoption of multi-disciplinary approaches for use of Electronic Brachytherapy to deliver IORT for breast and other cancers. We are encouraged that studies reinforce the clinical value of IORT applications for eBx, and strongly believe that providing a safe and portable method to deliver treatment to the lumpectomy cavity as soon as the tumor is removed and before any remaining cells have a chance to reproduce, is extremely important to improving patient care.”