MARIETTA, GeorgiaXoft, Inc.'s Axxent Electronic Brachytherapy System for accelerated partial breast irradiation (APBI) recently had its first clinical use in two lumpectomy patients treated at WellStar Kennestone Hospital. Treatment was overseen by Philip Z. Israel, MD, director of The Breast Center in Marietta.
Unlike other APBI delivery systems that use radioactive isotopes, the Axxent system uses ionizing radiation delivered by a portable high-dose-rate x-ray source into a balloon applicator in the lumpectomy cavity. Therapeutic radiation doses are delivered to the tumor bed in 10 fractionated treatments over a 5-day period. A shield is placed over the patient's breast during treatment. Radiation to personnel is minimal, eliminating the need for heavily shielded environments.
"Unlike brachytherapy sources containing radioactive isotopes, the Electronic Brachytherapy x-ray source can be turned on and off at will, enabling it to be delivered in many clinical settings," said Kenneth Haile, MD, medical director of the Radiation Oncology Department at WellStar Kennestone Hospital.
The Axxent system received 510(k) clearance from the FDA in December 2005. Said Michael Klein, Xoft CEO and president, "We are proud to work with WellStar Kennestone Hospital to make this breakthrough new treatment available to breast cancer patients. As WellStar and our other clinical sites begin to incorporate the Axxent System into routine practice, we are convinced that electronic brachytherapy represents a paradigm shift in radiation therapy."