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Women with Early Breast Cancer Now Have Access to New Single-Dose Radiation Treatment at Holy Cross Hospital

Intrabeam Single Dose Intraoperative Radiation Delivery

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross is first in South Florida to offer INTRABEAM® Radiotherapy System

The Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital is the first medical center in South Florida to offer early breast cancer patients a new form of single-dose radiation treatment that may reduce some of the potential side effects associated with conventional radiation treatment. The revolutionary new treatment utilizes advanced technology, known as the INTRABEAM® Radiotherapy System, to deliver targeted, intraoperative radiotherapy (IORT) directly to the tumor site during a patient’s lumpectomy.

"Delivering radiation therapy in the operating room provides a less invasive treatment option for our patients who have been diagnosed with early stage breast cancer," said surgical oncologist Dr. Joseph Casey of Holy Cross Hospital. "Compared to more traditional radiation treatments, intraoperative radiotherapy provides multiple benefits for patients who are candidates."

Intraoperative delivery allows radiation to be applied in the area of the breast where the tumor was located. This ensures radiation delivery accuracy and minimizes geographical miss. The INTRABEAM radiation is applied for 20 to 30 minutes, exposing the affected tissue in the tumor bed from the inside. The surgeon then removes the INTRABEAM applicator and closes the incision.

INTRABEAM radiotherapy delivered during surgery may provide a viable treatment alternative for patients meeting specific treatment conditions. Unlike whole breast radiation treatment, which is administered daily for up to six weeks, INTRABEAM IORT provides eligible patients with a convenient, innovative medical breakthrough and a treatment option that may be more easily incorporated into a patient’s daily life.

In addition to the convenience of radiotherapy delivered during surgery, the INTRABEAM system has been shown to provide additional benefits compared to traditional conventional external beam radiotherapy (EBRT). These include less irritation of healthy breast tissue, minimized exposure to the chest cavity and underlying organs, and fewer skin reactions, such as redness, rashes and irritation. There is also no treatment delay for patients who must also undergo chemotherapy as part of the breast cancer treatment compared to EBRT, which can require up to a one month delay in radiation treatment.

IORT was successfully introduced through an internationally randomized, controlled clinical trial called TARGIT-A, which compared a single dose of radiation given intraoperatively to EBRT in women with early breast cancer. The TARGIT-A clinical trial, the largest randomized clinical trial conducted in the field of IORT for the treatment of breast cancer, was launched in 2000 and enrolled 2,232 patients throughout 28 centers in nine countries.

The Michael and Dianne Bienes Comprehensive Cancer Center, through collaboration with Massachusetts General Hospital Cancer Center, offers disease-specific care in all oncology sub-specialties including medical, surgical and radiation oncology. It is certified by the Quality Oncology Practice Initiative, received accreditation from the National Accreditation Program for Breast Centers, and was first in the nation to be named as a local treatment partner of the National Cancer Institute.

For more information or to find out if you or someone you know is a candidate for INTRABEAM intraoperative radiotherapy, please contact the Holy Cross Medical Group Surgical Oncology office at the Bienes Cancer Center at 954-772-6700.

For more information about the INTRABEAM system, please visit www.meditec.zeiss.com/intrabeam. For more information about the TARGIT-A clinical trial, please visit www.targit-research.org or www.targit.org.uk.

About Holy Cross Hospital
A member of Catholic Health East, Holy Cross Hospital in Fort Lauderdale, Fla. is a full-service, non-profit Catholic hospital, sponsored by the Sisters of Mercy. Since opening its doors in 1955, the 559-bed hospital has offered progressive services and programs to meet the evolving healthcare needs of Broward County. Today, Holy Cross has more than 600 physicians on staff representing more than 40 specialties and more than 3,000 employees. The hospital is fully accredited by the independent Joint Commission and its medical team has earned a reputation for excellence unsurpassed in the community. To learn more about Holy Cross, visit www.holy-cross.com.

About the INTRABEAM Radiotherapy System
INTRABEAM, Carl Zeiss Meditec's radiotherapy system, offers the least disruptive treatment method available to patients diagnosed with early stage breast cancer. The INTRABEAM radiation dose is administered to the tumor bed in the operating room immediately following the surgical excision of the tumor. The system utilizes a miniature X-ray source, a highly flexible support stand, and a full range of radiation applicator options. INTRABEAM has the advantage of delivering a precise radiation dose to the tumor site at the time of surgery, minimizing geographical miss and the associated side effects with external beam radiation. Afterwards, the applicator and miniature X-ray source are removed, the surgical site is closed, and the procedure is complete. Please visit www.meditec.zeiss.com/intrabeam for more information.

US FDA-Cleared Indications for Use:
The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM Radiotherapy System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavitary or intraoperative radiotherapy treatments. The INTRABEAM Balloon Applicator together with the INTRABEAM system is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy of breast cancer. The safety and efficacy of the INTRABEAM system as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.

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