ALISO VIEJO, Calif., Dec. 20, 2016 /PRNewswire/ -- A presentation at the annual San Antonio Breast Cancer Symposium (SABCS) provided the first report from a nationwide registry regarding the BioZorb® marker in treatment of women who have breast cancer. The registry data outlined clinical benefits that surgeons have seen with the FDA-cleared implantable marker.
Researchers reported that oncoplastic surgery was used in nearly three-fourths of the cases covered by registry data. This increasingly common form of breast-conserving surgery emphasizes both cancer control and a better cosmetic outcome. It uses the patient's own breast tissue to reconstruct and reshape the breast in order to avoid deformities that can occur after healing from surgery and radiation.
"This device facilitates our use of oncoplastic techniques," said Jennifer Gass, M.D., a poster co-author and Chief of Surgery at Women & Infants Hospital (Providence, R.I.). "We find that surgeons who may have not been doing oncoplastic approaches, once they start using the device, are going to perform oncoplastic surgery and get better cosmetic outcomes for their patients."
Cosmetic outcomes for the 300 procedures covered by the poster at SABCS were rated as good or excellent by more than 90% of the patients and physicians. Data was collected by 18 researchers at 16 different facilities around the U.S.
"Cosmetic outcome matters because of its impact on patients in their survivorship," Dr. Gass said. "Body image for women with this defining organ of femininity is important. We strive for a better aesthetic outcome so that after treatment, the patient is not self-conscious about her appearance." Dr. Gass is co-director of The Breast Health Center at Women & Infants and an associate professor of surgery and associate professor of obstetrics and gynecology at The Warren Alpert Medical School of Brown University.
Sharad Goyal, M.D., the co-principal investigator on the registry, said the data provides additional validation for the utility of the BioZorb marker:
"The registry encompasses patients from all across the U.S. and is extremely diverse in terms of breast size, tumor type and type of surgical procedure. It is our hope the results from this study can be extrapolated to a larger general population," noted Dr. Goyal, who is a radiation oncologist at Rutgers Cancer Institute of New Jersey.
BioZorb is the first and only device that identifies in a reliable way the three-dimensional region where the tumor was removed. By suturing the implant to the tumor bed, the surgeon can more precisely indicate to the radiation oncologist where the cancer was located. Because of the marker's unique configuration, it allows oncoplastic surgery to be used for reconstructing the breast with the patient's own tissues, while at the same time delineating the tumor's previous location.
The marker consists of a framework made of a bioabsorbable material that holds six titanium clips. The implant serves as a guide for the radiation oncologist during planning of radiation treatments that are delivered after surgery. The device's framework slowly dissolves in the body over the course of a year or more. The marker clips remain at the surgical site and are also helpful for long-term monitoring with clinical imaging such as mammograms.
"Oncoplastic breast surgery has in part been held back because of the lack of the radiation oncologist's ability to target what they need to treat effectively," Dr. Goyal said. "If you're able to better identify the tumor site, you can in many cases use partial breast irradiation, which reduces cost and improves patient convenience and satisfaction."
The poster at SABCS reported on 300 patients with a median follow-up of 10.4 months. Median patient age was 64.4 years. Breast size was evenly distributed between cup sizes B, C and >D. Cancer histology was in-situ (20%), invasive ductal (62%), invasive lobular (9%) and others (10%) measuring T1 (80%) and T2 (20%). Laterality and tumor location within the breast were typical. Re-excision (including mastectomy for extensive disease) occurred in 14% of patients. Infections occurred in 2% of patients. No devices were removed during follow-up due to misplacement or patient-generated concerns. No cancer recurrences have been reported.
The lead author of the poster presentation and co-principal investigator on the registry was Cary Kaufman, Medical Director of the Bellingham Regional Breast Center and past chairman of the National Accreditation Program for Breast Centers.
Dr. Kaufman also presented a second poster at the SABCS meeting, outlining details from 61 cases (12 month follow-up) in which he used the BioZorb marker and oncoplastic surgery techniques. He reported good to excellent cosmesis that "may be related to the addition of volume to the lumpectomy bed not seen with rearrangement of existing tissues."
SABCS was held Dec. 6-10 in San Antonio.
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About Focal Therapeutics
Focal Therapeutics is a medical device company based in Aliso Viejo, Calif. The company's BioZorb marker is a proprietary bioabsorbable device that provides radiographic marking of soft tissue sites. The BioZorb device is placed at the time of surgical removal of tissue, such as during breast surgery, and the device's three-dimensional array of marker clips has unique clinical utility for patient imaging. BioZorb has received 510(k) clearance from the U.S. Food and Drug Administration. The device is available in a range of sizes to accommodate a variety of clinical situations. For more information about the company, call (U.S.) 650-530-2394 or email info@focaltherapeutics.com.
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