May 03, 2008

FORT MYERS, Fla. – Physicians at 21st Century Oncology, Inc., a leading developer and operator of radiation therapy centers, recently presented research on their use of the SAVI™ applicator for breast brachytherapy. The scientific poster presented at the 25th Annual Miami Breast Cancer Conference found that SAVI applicator’s superior dose control resulted in a low rate of toxicities, especially skin reactions.

The poster presented by lead researcher Constantine Mantz, M.D., a radiation oncologist at 21st Century, was recognized as one of the top three presentations at the conference.

SAVI is a single-entry, multi-catheter device that delivers radiation as part of breast conservation therapy. It is the only accelerated partial breast irradiation (APBI) single-entry device that can customize the dose according to patient-specific anatomy. By targeting the radiation more precisely, SAVI treats the tissue where the cancer is most likely to recur, while minimizing the exposure of healthy tissue such as the skin, chest wall or lungs.

The 21st Century Oncology study examined the toxicity levels observed in the first 90 days following radiation treatment with SAVI. Of the 18 patients included in the study, 14 of them experienced no skin reactions, which are a common side effect of radiation therapy. Of the four patients who experienced skin reactions, all had just minor reactions that were quickly resolved, without the need for additional care.

Researchers rated the overall cosmetic outcomes with SAVI as “excellent.”

“SAVI allows me to pull radiation dose away from the skin and lung and push it into the breast tissue where it is needed, to destroy cancer cells and prevent recurrences,” said Dr. Mantz. “Our study demonstrated that SAVI’s ability to shape the dose of radiation results in very low toxicity and allows more women to be treated safely with breast brachytherapy.”

Nearly 60 percent of the patients in the study had tumors located close to the skin surface. That tumor location excluded them from treatment with balloon brachytherapy, an older form of breast brachytherapy.

“Roughly 30 to 40 percent of patients that I see regarding partial breast brachytherapy would not be good candidates for balloon brachytherapy because of technical restrictions, such as the tumor being located too close to the skin or lungs,” said Dr. Mantz. “SAVI allows these patients, who would otherwise not be eligible, to receive breast brachytherapy because we can deliver the dose much more precisely.”

“SAVI really is the next step in radiation therapy where you can make the radiation conform to the anatomy of the patient and the tumor,” said Paul Wallner, DO, FACR, FAOCR, Senior Vice President of 21st Century Oncology. “We see it as a better option for clinical care for our patients. With SAVI, there is a greater potential for more women to benefit from APBI.”

The research poster from Dr. Mantz and colleagues was named one of the top three presentations by the program committee of the Miami Breast Cancer Conference. These three posters, out of approximately 40 submissions, were honored based on their outstanding scientific merit, applicability and impact in breast cancer, and innovation/originality, according to MBCC course director Debu Tripathy, M.D.

“My main objective in presenting our data to the medical public is to make physicians aware of this new device for delivering partial breast irradiation at least as an alternative – and perhaps a replacement – to MammoSite balloon brachytherapy for patients who have tumors located close to the skin or lung,” said Dr. Mantz.

Breast conservation therapy includes lumpectomy – the surgical removal of the cancerous tissue within the breast plus tissue immediately surrounding the tumor – followed by radiation. Typically, radiation therapy after a lumpectomy has involved treatment of the entire breast with external beam radiation. Known as whole breast irradiation (WBI), this
approach exposes more healthy tissue and requires a much longer treatment course, with radiation delivered five times a week over a six-to-seven week period. Treatment with the SAVI applicator lasts just five days. Partial breast brachytherapy is becoming a more widely used alternative to whole breast irradiation.

The SAVI applicator is made by Cianna Medical, Inc., a women’s health company dedicated to the innovative treatment of early-stage breast cancer. The Miami Breast Conference was held, Feb, 20-23, 2008, in Orlando, Fla.

About 21st Century Oncology, Inc.
21st Century Oncology, Inc. is a leading developer and operator of radiation therapy
centers. These centers, which are freestanding and hospital based, provide a full spectrum of radiation therapy services to cancer patients. In its more than 20 years of operation, the company has developed an operating model which enables the company’s centers to deliver high quality, cost effective patient care. Currently, the company operates more than 84 centers in 16 states, including Alabama, Arizona, California, Delaware, Florida, Kentucky,
Maryland, Massachusetts, Michigan, New Jersey, New York, Nevada, North Carolina, Pennsylvania, Rhode Island and West Virginia.
21st Century Oncology is the wholly-owned subsidiary of Radiation Therapy Services, Inc. For more information, go to www.rtsx.com