Over 2,000 early-stage breast cancer patients have undergone intraoperative radiation therapy (IORT) with iCAD, Inc.'s Xoft Axxent Electronic Brachytherapy (eBX) System, according to data presented yesterday at the San Antonio Breast Cancer Symposium.

"We continue to be encouraged by the number of clinicians who are choosing to make this option available for patients who meet specific clinical criteria established by the various medical societies," Ken Ferry, CEO of iCAD, told HCB News. "Treatment decisions are supported by a growing body of clinical data and recognition of the many patient's benefits a shorter course of therapy offers."

Compared to conventional breast cancer treatment, which involves daily radiation five days per week for six to eight weeks, IORT involves only a single dose of targeted radiation. The radiation oncologists and breast cancer surgeons collaborate during a lumpectomy to deliver the full dose of radiation to the cancer cells, which spares the healthy tissue including the heart, lungs and ribs.




The Xoft system uses a miniaturized X-ray source, which is inserted into a flexible applicator shaped like a balloon, and then the applicator is placed inside of the lumpectomy cavity during the roughly eight-minute treatment. Since the system uses an X-ray source, rather than a decaying radioactive isotope, it can be turned on or off so that it isn't always emitting radiation.

More and more clinical studies are supporting the use of IORT in patients who meet specific selection criteria. One of the biggest IORT clinical studies is currently being conducted by iCAD, which is comparing Xoft IORT to traditional external beam radiation therapy.

At this year's ASTRO meeting in October, Dr. Ajay Bhatnagar and Dr. Parag Sanghvi presented data that showed positive clinical results, excellent-to-good cosmesis, few recurrences and a low rate of low-grade adverse events when the Xoft system was used to treat 136 breast cancer lesions.

The Xoft system is FDA cleared, CE marked and licensed in Canada to be used to treat cancer anywhere in the body including early-stage breast cancer, gynecological cancers and non-melanoma skin cancer.

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