A woman with early-stage breast cancer became the first patient to receive a single, concentrated dose of intraoperative radiation therapy (IORT) following surgery using the Xoft system, in a clinical study taking place in the United States and elsewhere.
The patient was treated at the Monash Cancer Centre in Melbourne, Australia, iCAD said in a press release, noting that the procedure can be completed in one eight-minute session, compared to six to eight weeks for standard radiation therapy,
The clinical study, called the ExBRT trial (NCT01644669), is testing the safety and efficacy of single-dose and isotope-free radiation using the Xoft System against traditional whole breast irradiation in women with early-stage cancer. It plans to enroll about 1,200 people at 26 sites across the United States as well as one site each in Australia and Portugal. Many centers are still recruiting patients; more information is available here.
Using the Xoft System, oncologists and surgeons work together during a lumpectomy to administer a concentrated but low-energy dose of radiation, given through a small balloon applicator inserted into the breast cavity created by the surgery. This potentially directs radiation to the cancer site while preserving nearby healthy tissue. It uses X-ray radiation instead of radioactive material as a treatment, allowing medical personnel to remain in the room with the patient.
“Intraoperative radiotherapy will offer women with early-stage breast cancer another therapeutic option, and, we believe, a better patient experience with less treatment morbidity, and a more rapid return to normal activity,” said Jane Fox, director of breast services at Monash Health. “We are encouraged by the research to date as the global community of treatment centers continues to provide appropriate patients with the unique option to complete a full dose of radiation therapy in a single treatment.”
iCAD showcased the system at the recent annual meeting of the American Society of Breast Surgeons, and is licensing the system for sale in an increasing number of countries. Xoft is cleared to treat non-melanoma skin cancer and gynecological cancer, as well as early-stage breast cancer.
“Monash Cancer Centre’s participation in the ExBRT trial offers important growth of the body of international clinical data demonstrating the safety and efficacy of the Xoft System for appropriate patients,” said Ken Ferry, chief executive officer of iCAD. “We remain committed to continuing to expand research to identify additional treatment areas like IORT that have the potential to transform the treatment of cancer for patients worldwide.”