May 03, 2011

Multi-Site Study on Breast Cancer Radiation Therapy Represents Largest Cohort of SAVI Patients

ALISO VIEJO, Calif. – Initial findings from the SAVI® Collaborative Research Project (SCRP), on SAVI radiation therapy for breast cancer, were presented at the recent annual meeting of the American Brachytherapy Society (ABS).

The SAVI Collaborative Research Project was established to produce additional research, presentations, and peer-reviewed, published literature on SAVI. The data collected thus far represents the largest subset of patients who have received accelerated partial breast irradiation (APBI) with the SAVI applicator.

The registry is lead by Catheryn Yashar, M.D., of the UC San Diego School of Medicine, and Robert R. Kuske, M.D., a pioneer in APBI and medical director at Arizona Breast Cancer Specialists.

“The SAVI registry is adding important scientific knowledge to the field of APBI,” said Dr. Yashar, who presented the initial data in a podium presentation at ABS. “Because there are several forms of APBI, this research allows us to compare the various forms and better determine which devices are suited to particular types of patients.”

The findings presented at ABS are the first to be reported from the SCRP. Based on a retrospective review of 294 patients treated at five clinical sites, researchers concluded the overall dosimetry of SAVI was excellent and that the data demonstrate SAVI’s unique ability to sculpt the radiation dose away from the skin and ribs while selectively treating targeted tissue.

The SAVI multi-catheter applicator is available in four sizes designed to fit different surgical cavity sizes. The research presented at ABS showed that the two sizes used to treat larger cavities provide dosimetric coverage that is comparable to published data for various forms of “balloon” breast brachytherapy devices. The two sizes for women with smaller breasts and cavities were found to be useful in cases where anatomical restrictions might preclude use of a balloon device.

SAVI delivers accelerated partial breast irradiation APBI as part of breast conservation therapy (BCT). By specifically targeting radiation where the cancer is most likely to recur, SAVI reduces treatment time from six weeks with traditional whole-breast irradiation, to just five days.

The SAVI device allows physicians to customize radiation dose based on patient-specific anatomy, and is the ideal single-entry breast brachytherapy treatment method when the skin and ribs are close to the lumpectomy cavity. This unique ability can make the benefits of APBI available to twice as many women, as well as result in better outcomes including less skin toxicity, reduced risk of infection and improved cosmesis.

“Breast conservation therapy is now preferred over mastectomy for early stage breast cancer because the survival rates are the same and BCT allows the woman to preserve her breast and sense of wholeness,” said Dr. Kuske. “For many women with busy lives, a 6-7 week course of radiation is prohibitive, so a 5-day alternative is very attractive. Women are also drawn to APBI because it minimizes radiation exposure to other parts of the body. In the evolution of this shorter, more targeted treatment option, the SCRP study demonstrates that size and anatomy no longer need to restrict eligibility for APBI. For many of my patients, SAVI has been my treatment of choice.”

Dr. Yashar is associate professor of radiation oncology at the UC San Diego School of Medicine and chief of breast and gynecological radiation services at the Moores UCSD Cancer Center. The ABS annual meeting was held April 14-16 in San Diego.

About Cianna Medical

Cianna Medical, Inc. is a medical device company focused on women’s health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The SAVI applicator allows precise sculpting of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women.

For more information, call (toll-free) 866-920-9444 or visit www.ciannamedical.com.

Contact: Liz Dowling, (760) 942-2544
Dowling & Dennis Public Relations
E-mail: Liz@DowlingDennis.net