September 22, 2008 - A new study of breast cancer radiation treatment performed at 21st Century Oncology has found that Cianna Medical's SAVI applicator delivered excellent cosmetic results with minimal side effects, for women who had not qualified for breast conservation therapy using a previously available balloon device, according to the study.
Reporting on 12 recent cases, the 21st Century Oncology study found no incidence of potential side effects such as seroma (fluid collection), pigmentation change, fibrosis (scar tissue) or infection. Indicating the precision of the SAVI applicator, the maximum skin dose of radiation for patients never exceeded the prescribed amount. In 92 percent of the cases, the cosmetic result was rated “excellent.”
The research team was led by Constantine Mantz, M.D., of 21st Century Oncology, one of the first medical organizations in the nation to offer this new and improved approach in breast brachytherapy, a radiation treatment that is delivered from inside the breast.
The study will be presented as a scientific poster ASTRO 2008.
Breast conservation therapy includes lumpectomy – the surgical removal of the cancerous tissue within the breast plus a small margin of normal tissue immediately surrounding the tumor – followed by radiation. SAVI is a single-entry, multi-catheter device that allows the physician to customize the radiation dose depending on the patient’s anatomy and precise configuration of the surgical site.
“Our study demonstrated that SAVI provides a well-tolerated therapy for patients who otherwise would not be able to safely undergo treatment with the previously available balloon device,” said Dr. Mantz. “SAVI offers the physician multiple catheters for radioactive source loading and therefore total control over radiation dose distribution.”
Explaining the advantages for both physicians and patients, Dr. Mantz said, “I can lightly load catheters near the skin or lung to limit exposure of these sensitive structures. Also, I can heavily load catheters deep within breast tissue, to increase the radiation dose to places where the patient is at risk for harboring microscopic disease. We are very pleased with our clinical outcomes to date with SAVI.”
Prior to doing the study, Dr. Mantz and his research team believed that the multi-catheter applicator’s design might offer a preferable alternative for patients whose tumor cavities were too close to the skin for treatment with the previously available balloon method. Patients whose tumor cavities are within 7 mm of the chest wall or skin surface are often disqualified for treatment with the balloon device because of a potentially severe lung or skin reaction to the radiation.
This study tested the hypothesis by using the SAVI device to treat 12 patients who were found to have less than 7 mm skin-to-cavity spacing. None of the patients suffered a serious skin reaction to the treatment.
The device requires very little spacing between the cavity and healthy tissue, versus other brachytherapy devices that require several millimeters. Accordingly, SAVI expands the number of women eligible for brachytherapy, compared to balloon devices.
The SAVI applicator is a recent advance in accelerated partial breast irradiation (APBI). This shortened course of high-dose radiation therapy is designed for early-stage breast cancer patients following lumpectomy surgery. Breast brachytherapy is a type of APBI in which radiation is delivered from within the breast. APBI reduces treatment time from six or seven weeks – which is generally required with conventional external beam, whole-breast irradiation – to just five days.