October 25, 2018 — iCAD Inc. announced new clinical research demonstrating positive outcomes supporting the use of the Xoft Axxent Electronic Brachytherapy (eBx) System for the treatment of early-stage breast cancer. Preliminary results demonstrated that intraoperative radiation therapy (IORT) using the Xoft System is safe, with excellent local control and cosmesis, and low morbidity. The analysis of the international, multi-center trial was unveiled during an oral presentation at the 60th American Society for Radiation Oncology (ASTRO) annual meeting, Oct. 21-24 in San Antonio, Texas.
In the presentation, A.M. Nisar Syed, M.D., principle study investigator, and medical director, radiation oncology and endocurietherapy, MemorialCare Cancer Institute, Long Beach Memorial Medical Center, and professor of radiation oncology, UCI Medical Center and Harbor-UCLA School of Medicine, detailed clinical techniques and outcomes of IORT using the Xoft System at the time of breast conserving surgery with findings based upon ASTRO suitability criteria. The trial enrolled 1,201 patients between May 2012 and July 2018 at 28 international and U.S.-based institutions. With a median follow up of two years, less than 1 percent of patients had cancer regrowth (ipsilateral recurrence) or developed new primary cancers in the other breast. Treatment was well tolerated, with grade 3, 4 and 5 adverse events occurring in only 37 patients. Mean treatment time was 10.5 minutes.
“Our research continues to demonstrate significant promise in the treatment of early-stage breast cancer with IORT using the Xoft System. Preliminary outcomes show that a single fraction of radiation with the Xoft System yields excellent results in patients meeting specific selection criteria,” said Syed. “By greatly reducing the number of treatment patients receive as compared to traditional radiation therapy, IORT provides valuable advantages to patients including shorter treatment times, fewer side effects, reduced costs and improved quality of life.”
In addition to the new data release at the annual meeting, iCAD hosted a series of in-booth expert presentations and peer-to-peer learning opportunities led by Syed and other global experts, including:
- Paulo Costa, M.D., radiation oncologist, Instituto CUF Porto, Breast Surgery Unit Senhora da Hora, Matosinhos, Portugal;
- Charles Wesley Hodge, M.D., radiation oncologist, Florida Hospital Celebration Health, Celebration, Fla.; and
- Chun-Shu Lin, M.D., chief, Department of Radiation Oncology, Tri-Service General Hospital, Taipei City, Taiwan.
IORT with the Xoft System uses a miniaturized X-ray source to deliver one precise, concentrated dose of radiation to a tumor site at the time of breast-conserving surgery (lumpectomy). The treatment can be completed in as little as eight minutes, making it possible for appropriately selected patients to replace six to eight weeks of post-operative external beam radiation therapy (EBRT) with a single treatment.
The Xoft System is cleared by the U.S. Food and Drug Administration, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer, and gynecological cancers.
For more information: www.xoftinc.com