October 28, 2012

BOSTON. — Breast brachytherapy with a strut-based applicator had favorable toxicity rates and cosmetic outcomes, according to research delivered at the 54th annual meeting of the American Society for Radiation Oncology (ASTRO).

A presentation by Robert L. Hong, M.D., also concluded that the strut-based applicator showed “excellent” local control of breast cancer recurrence and had favorably low rates of complications such as seroma, hyperpigmentation and telangiectasia, which are potential side effects of any form of radiation therapy.

The data represents the largest toxicity study of accelerated partial breast irradiation (APBI) patients who have received strut-based breast brachytherapy to date. Hong reported on 515 patients treated with the SAVI® (Strut-Adjusted Volume Implant) applicator from eight sites around the U.S., with a median follow-up time of 26 months. Dr. Hong is a radiation oncologist at the Virginia Hospital Center, in Arlington, Va.

“This analysis reflects the unique ability of strut-based devices to modulate the radiation dose, thereby sparing healthy tissue and resulting in lower toxicities.” said Dr. Hong. “Overall, the rates of radiation-related toxicity never exceeded 3.1% which is very low and compares favorably to rates reported in studies of other forms of breast brachytherapy”

A second study at the ASTRO conference reported excellent or good cosmetic outcomes in more than 90% of patients, even those with the lumpectomy cavity in close proximity to the skin, who had strut-based brachytherapy. The analysis presented by Dr. Steven Finkelstein, a radiation oncologist at 21st Century Oncology, in Scottsdale, Az., covered patients in three stages after treatment, including 146 breasts two years after brachytherapy.

The SAVI Collaborative Research Group, from which the data at ASTRO was drawn, was established to study clinical outcomes of APBI treatment with the SAVI device.

Other recent reports from the research group include the longest-term data on strut-based brachytherapy, which was presented in July at the Breast Cancer Coordinated Care Conference (BC3).

That data from Robert Kuske, M.D., Catheryn Yashar, M.D. and colleagues covered 70 patients with a median follow-up of four years. Researchers concluded the applicator provided effective and well tolerated treatment, with the ability to eliminate skin-spacing limitations inherent in other brachytherapy devices.

“The local recurrence rate in this group was low, at only 1.4%,” said Dr. Yashar. “Also, the data indicated this device allows more women to choose five-day brachytherapy instead of six weeks of external-beam radiation by allowing treatment despite tumorbeds in close proximity to the skin.”

Strut-based brachytherapy is a method of delivering APBI, a shortened course of radiation therapy for early-stage breast cancer patients following lumpectomy surgery. Until the advent of the strut-based device, breast brachytherapy was delivered either with a balloon-based device or by the insertion of a multitude of catheters. Many patients are not eligible for treatment with the balloon device because the location of the lumpectomy cavity is in close proximity to healthy tissues such as the skin, heart, ribs, or lungs.

The strut-based applicator was developed to improve patient care and increase the number of women who are eligible for APBI by enabling physicians to sculpt radiation according to patient-specific anatomy. The reports presented at the ASTRO and the BC3 conferences are among several clinical studies showing that by providing targeted radiationwhere it is needed most, the risks of toxicity and cosmetic side effects are reduced.

This form of radiation treatment is part of breast-conservation therapy, which includes lumpectomy – the surgical removal of the cancerous tissue within the breast plus tissue immediately around the tumor – followed by radiation. The breast-conserving approach is an alternative to mastectomy, which removes the entire breast and is often followed by breast reconstruction.

Radiation treatment after a lumpectomy has traditionally involved irradiation of the entire breast with an external beam, over six weeks of treatment. Besides the inconvenience of the lengthy regimen, many women must travel some distance to receive external-beam radiation. That can put additional stress on their families, jobs, and financial resources.


How the strut-based applicator works

Video and text:
Lower toxicities with strut-based brachytherapy: 4-year results

APBI paradigm shift in breast cancer treatment
Strut-based applicator and ductal carcinoma in situ (DCIS)

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.

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