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Last updated on April 20, 2014 at 14:04 EDT

Many Women in the U.S. with Breast Cancer may be NOW eligible for One-Day Treatment

August 13, 2012

SUNNYVALE, Calif., Aug. 13, 2012 /PRNewswire/ — A European cancer center of excellence, Ospedale Borgo Trento in Verona, Italy, recently published a study of 226 women with early-stage breast cancer that received a single dose of Intra-Operative Electron Radiation Therapy (IOERT) using the IntraOp Medical Corporation Mobetron® (OTC: IOPD) during surgery to remove their breast tumor. 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 prestigious, peer-reviewed, 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-to-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 in one 2-minute treatment. There is no further radiation that patients require.

“Single dose IOERT in early-stage breast cancer can be delivered safely and with excellent results,” concludes 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 1-dose procedure and avoid 6 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% of the U.S. breast cancer population,” says Don Goer, PhD., 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),” says Dr. 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,” Dr. Goer explains, “the EIO showed that the long-term (5-year median follow-up), recurrence rates were 1.5% for ASTRO suitable women treated with IOERT ABPI, equivalent to the ASTRO suitable women treated with the standard 6-week procedure. These low recurrence rates of 1.5% at 5 years were also seen for ASTRO suitable women in another EIO published study of 1822 women treated with IOERT APBI outside of the trial.”

“The positive results from Europe and elsewhere using IOERT APBI has encouraged us to offer this treatment to women with low-risk breast cancer,” says Dr. Jay Harness, breast surgeon at St. Joseph’s Hospital in Orange, CA and a past-president of The American Society of Breast Surgeons (ASBS). “We have offered IOERT boost to our patients for the past 3 years. With the addition of IOERT APBI, either as a boost or as IOERT APBI,” Dr. Harness continues, “we can now offer our patients the optimal IOERT treatment for their breast cancer.”

Additionally, Dr. Julie Reiland, breast surgeon at Avera Regional Medical Center and an expert in oncoplastic reconstruction combined with IOERT, says, “We have been participating in the international IOERT breast boost trial combined with three weeks of external beam radiation for over a year. Many of our patients must travel long distances for their treatment. For those who are eligible, IOERT APBI would be the ideal way to treat them. We plan to begin offering IOERT APBI single dose as soon as our IRB approves our protocol.”

“Women with breast cancer who present to Mobetron centers in Belgium, Italy, Poland, Spain, The Netherlands, Japan, China and Thailand, have been able to benefit from this one-day treatment,” says John Powers, CEO of IntraOp Medical. “More than 16,000 women have been treated with IOERT for breast cancer, about half as APBI. Now that our U.S. Mobetron centers are using or planning to use IOERT APBI, women in the US will be able to benefit from a breast treatment that has been widely used internationally for many years.”

About IntraOp

IntraOp Medical Corporation provides innovative technology solutions for the treatment and eradication of cancer. Founded in 1993, IntraOp is committed to providing the tools doctors need to administer IOERT safely and effectively for all cancer patients. The Mobetron is the first IOERT device designed for use in existing operating rooms and has been used to treat over 20 different cancer indications. Mobetron benefits include: increased survival rates, better local tumor control, shorter treatment cycles, and happier patients with fewer side effects. Leading hospitals and clinics throughout the world use the Mobetron as a vital part of their comprehensive cancer program. For more information email info@intraopmedical.com or call 408-636-1020 x128.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the 1933 Securities Act and Section 21E of the 1934 Securities Exchange Act. By making these forward-looking statements, the Company can give no assurances that transactions described in this press release will be successfully completed, and undertakes no obligation to update these statements for revisions or changes after the date of this press release.

SOURCE IntraOp Medical Corporation


Source: PR Newswire