The study was a long-term follow-up of clinical results with Axxent for intraoperative radiation therapy (IORT) performed at the time of breast-conserving surgery. The principal investigator was Dr. Nisar Syed of Long Beach Memorial Medical Center, University of California Medical Center, and Harbor-UCLA School of Medicine.
The trial enrolled 1,201 patients from May 2012 to July 2018 at 28 institutions worldwide and in the U.S. At a median follow-up of two years, fewer than 1% of patients experienced regrowth of their cancer (ipsilateral recurrence) or developed new primary cancers in the contralateral breast. Patients tolerated the treatment well, with grade 3, 4, and 5 adverse events occurring in only 37 patients. Mean treatment time with Axxent was 10.5 minutes.
The results indicate that a single fraction of radiation with Axxent electronic brachytherapy yields excellent results in patients with early-stage breast cancer who meet clinical criteria, according to Syed. The technology can also greatly reduce the number of treatments compared with what is required with whole-breast radiation therapy.
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