August 21, 2012 — Ospedale Borgo Trento in Verona, Italy, recently published a study of 226 women with early-stage breast cancer that received a single dose of intraoperative electron radiation therapy (IOERT) using the IntraOp Mobetron from IntraOp Medical Corp. during surgery.
There was only one local recurrence after a mean follow-up of almost four years. The study was published by the University of Verona in the International Journal of Radiation Oncology, Biology and Physics, the professional journal for the American Society of Therapeutic Radiation Oncologists (ASTRO). This one-day treatment is called accelerated partial breast irradiation (APBI) with IOERT, or IOERT APBI.
There are several other APBI techniques that are currently under study, designed to shorten the 5-7 weeks of radiation that women with early-stage breast cancer normally require. These other APBI techniques range from one-day treatments like IOERT to five-day treatments, with some occurring during surgery and some as many as 2-3 weeks after surgery. IOERT APBI is the only breast treatment technique that is done on the day of surgery and in one 2-minute treatment, with no further radiation required.
"Single-dose IOERT in early-stage breast cancer can be delivered safely and with excellent results," said Sergio Maluta, professor emeritus at the University of Verona and principal investigator for the Verona study. "Patients at low risk of local recurrence represent an excellent group to receive a one-dose procedure and avoid six weeks postoperative radiation treatment."
ASTRO has identified low-risk women that are suitable for APBI treatments outside of a clinical trial. These are women over 60 years old with small tumors and favorable biology with no involved lymph nodes. "These low-risk women are about 30 percent of the U.S. breast cancer population," said Don Goer, Ph.D., IntraOp Medical's chief scientist. "That means about 75,000 women per year in the U.S. could be eligible for a one-day treatment using ASTRO criteria for APBI."
"The University of Verona results are also consistent with the data coming from the European Institute of Oncology (EIO)," added Goer. "Their randomized trial comparing IOERT APBI with the standard six weeks of radiation therapy has now been presented at a number of international meetings and is being prepared for publication this fall. In their presentations the EIO showed that the long-term (5-year median follow-up) recurrence rates were 1.5 percent for ASTRO-suitable women treated with IOERT ABPI, equivalent to the ASTRO-suitable women treated with the standard six-week procedure. These low recurrence rates of 1.5 percent at five years were also seen for ASTRO-suitable women in another EIO-published study of 1,822 women treated with IOERT APBI outside of the trial."
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