ALISO VIEJO, Calif., September 23, 2013– Cianna Medical, Inc., a women’s health company, today announced results of two new studies showing excellent longer-term outcomes with the SAVI® breast brachytherapy applicator, including low recurrence rates, few toxicities, excellent cosmetic outcomes and high rates of survival. A third study demonstrated SAVI’s ability to precisely deliver radiation while avoiding critical structures. SAVI is a strut-based applicator that delivers accelerated partial breast irradiation (APBI), a 5-day course of targeted radiation for early-stage breast cancer.
Data came from the SAVI Collaborative Research Group (SCRG), which studies the long-term outcomes of women treated with ABPI with SAVI and will be presented as posters at the 55th annual meeting of the American Society for Radiation Oncology (ASTRO), September 22-25, 2013, in Atlanta.
“APBI is an accepted treatment for certain women with early-stage breast cancer, with multiple Phase II and III clinical trials demonstrating its efficacy and safety,” said Robert Kuske, MD, co-principal investigator of the SCRG and a radiation oncologist at Arizona Breast Cancer Specialists, Phoenix, Ariz. “This new data further validates strut-based brachytherapy as a safe and effective method for delivering partial breast radiation, which means more women will have access to a treatment that delivers highly targeted radiation with much greater convenience.”
The first study detailed outcomes with the most mature follow-up of patients treated with strut-based APBI. The multi-institutional study examined 101 patients with a median follow-up of 4.5 years, reporting very low toxicity rates (< 3%) and excellent local control (2%). Overall and cause-specific actuarial survival rates were 100%.
“On longer follow-up, strut-based brachytherapy continually meets the standards we look for in a safe and effective breast cancer treatment – very high rates of survival and local control, few toxicities and excellent cosmetic outcomes,” said lead author Catheryn Yashar, MD, a radiation oncologist at UC San Diego’s Moores Cancer Center, La Jolla, Calif., and co-principal investigator of the SCRG.
A second study of a larger population (576 patients) with a median follow-up of 3 years reported similarly favorable results, including low toxicities and a local recurrence rate of less than 2.5%. Overall and cause-specific actuarial survival rates were 99.5%.
“Strut-based brachytherapy makes it possible to approach breast cancer treatment in a more sophisticated way. SAVI’s unique design enables physicians to customize radiation specific to the patient, allowing us to offer a very personalized level of care,” said lead author Robert Hong, MD, a radiation oncologist at Virginia Hospital Center, Arlington, Va.
The final study analyzed the radiation treatment plans for over 1,000 patients in the SCRG. The data demonstrated SAVI’s flexibility in shaping the radiation dose cloud, which researchers concluded protects critical structures and makes brachytherapy an option for patients who would not be candidates for other single-entry devices. The poster was presented by medical physicist Jay Reiff, PhD, a professor in the Department of Radiation Oncology at Drexel University Hospital, Philadelphia, Pa.
Strut-based APBI is part of breast conservation therapy (BCT), which consists of a lumpectomy followed by radiation therapy. Traditionally, radiation consisted of whole breast irradiation (WBI), which requires 6-7 weeks of daily treatments. APBI delivers radiation to the area immediately surrounding the lumpectomy cavity, enabling treatment to be completed in as little as 5 days and sparing healthy tissue from unnecessary radiation. The strut-based, open architecture design of SAVI allows physicians to sculpt radiation based on patient-specific anatomy, which increases the number of women eligible for APBI.
About Cianna Medical, Inc.
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 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.