Xoft reports clinical benefits of isotope-free electronic radiation therapy for treatment of cancer

Jun 15 2010

The clinical benefits of isotope-free electronic radiation therapy delivered directly to cancer sites with minimal exposure to surrounding healthy tissue continues to be substantiated by multiple publications, according to Xoft, Inc., developer of the Axxent® Electronic Brachytherapy, eBx™ System.  The leading provider of FDA-cleared Electronic Brachytherapy Systems, Xoft provides systems for single-dose intraoperative radiation therapy (IORT) and accelerated brachytherapy applications.  The most recent publication is four-year data from the TARGIT-A (Targeted Intraoperative Radiation Therapy) multicenter clinical trial presented this week at the 46th Annual ASCO Meeting and published in the current issue of the LANCET.

"We commend the TARGIT researchers and are encouraged that the study continues to reinforce the clinical value of isotope-free electronic treatment for IORT and accelerated brachytherapy applications," said Michael Klein, president and CEO of Xoft. "We are pleased with the growing adoption of IORT for breast and other cancers and we strongly believe that continued research will further prove its ability to improve patient care and similarly catalyze continued adoption."  

The TARGIT-A Trial is a randomized controlled trial designed to assess the equivalency of intraoperative radiotherapy with a single-dose against standard three to six week external beam radiotherapy after breast conserving surgery in women 45 years and over with invasive ductal carcinoma.

Results from 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," were also presented recently at ASBS by Olga Ivanov, M.D., breast surgeon and medical director for Little Company of Mary's Comprehensive Breast Health Center.  The 12-month results suggest that IORT utilizing Xoft's Electronic Brachytherapy is emerging as a novel, patient and physician friendly alternative to Whole Radiation Therapy (WBRT) as well as APBI in a selected group of patients with early breast cancer.  At a mean follow-up of 12 months, overall results were encouraging with excellent scores achieved in cosmesis and patient satisfaction.  While long-term follow-up will continue, no recurrences have been observed to date.  

"I believe that giving a single fraction of radiation at the time of surgery is advantageous because it allows all the radiation to be delivered before any remaining tumor cells have a chance to grow and intensifies the dose to the part of the breast at highest risk for recurrence," said Adam Dickler, M.D., radiation oncologist at Little Company of Mary Hospital. "Additionally, by working in concert to deliver IORT treatment, breast surgeons and radiation oncologists may be better able to decrease the number of patients who decide to be treated with surgery alone despite the fact that radiation has been shown to be an essential component of treatment and increases overall survival."

IORT is a technique where a concentrated dose of radiation is delivered to a cancerous tumor site during surgery after the tumor is removed.  Because the target and normal tissues can be clearly identified during surgery, IORT may increase targeting accuracy, thereby increasing dose to the target and reducing dose to critical structures. 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.

Available for treatment of early stage breast cancer, endometrial cancer, and skin cancer, the Axxent System is also FDA-cleared for IORT and surface indications, which allows the system to be used on any external or internal surface of the body where radiation therapy is indicated.  As a platform technology, the System delivers non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue.  In its treatment of early stage breast cancer, the Axxent System provides the opportunity to reduce the therapy time required from seven weeks (for external radiation therapy) down to five days or a single dose for IORT. Utilizing a miniaturized X-ray source instead of a radioactive isotope, the Axxent system can be used to deliver radiation in minimally shielded therapeutic settings allowing the radiation oncologist and other medical personnel to be present during treatment delivery which minimizes patient anxiety. As a result, tens of thousands of patients will have greater access to therapy that is delivered more easily and conveniently.