Cary S Kaufman1,2, Michael J Cross3, Julie L Barone4, Nayana S Dekhne5, Kiran Devisetty6, Joshua T Dilworth7, David A Edmonson8, Firas G Eladoumikdachi6, Jennifer S Gass9, William H Hall10, Robert L Hong11, Robert R Kuske12, Brandon J Patton4, Carol Perelson13, Rogsbert F Phillips14, Arnold B Smith15, Linda A Smith16, Lorraine Tafra17, Gail S Lebovic18. 1. Department of Surgery, University of Washington, Seattle, WA, USA. breastcare@aol.com. 2. Bellingham Regional Breast Center, 2075 Barkley Blvd. Suite 250, Bellingham, WA, USA. breastcare@aol.com. 3. Breast Treatment Associates, Fayetteville, AR, USA. 4. Saint Joseph Hospital, Denver, CO, USA. 5. Beaumont Hospitals, Southfield, MI, USA. 6. Karmanos Cancer Institute, Detroit, MI, USA. 7. William Beaumont Hospital, Royal Oak, MI, USA. 8. Womens Oncology, Women and Infants Hospital, Providence, RI, USA. 9. Women and Infants Hospital, Breast Health Center, Providence, RI, USA. 10. Radiation Oncology, PeaceHealth St. Joseph Medical Center, Bellingham, WA, USA. 11. Virginia Hospital Center, Arlington Health System, Arlington, VA, USA. 12. Arizona Breast Cancer Specialists, Scottsdale, AZ, USA. 13. , New York, NY, USA. 14. Metro Surgical Associates, Emory Healthcare, Atlanta, GA, USA. 15. Highlands Oncology Group, Fayetteville, AR, USA. 16. Comprehensive Breast Care, Albuquerque, NM, USA. 17. Anne Arundel Medical Center, The Breast Center, Annapolis, MD, USA. 18. School of Oncoplastic Surgery, Reno, NV, USA.
Abstract
BACKGROUND: Accurate identification of the tumor bed after breast-conserving surgery (BCS) ensures appropriate radiation to the tumor bed while minimizing normal tissue exposure. The BioZorb® three-dimensional (3D) bioabsorbable tissue marker provides a reliable target for radiation therapy (RT) planning and follow-up evaluation while serving as a scaffold to maintain breast contour. METHODS: After informed consent, 818 patients (826 breasts) implanted with the BioZorb® at 14 U.S. sites were enrolled in a national registry. All the patients were prospectively followed with the BioZorb® implant after BCS. The data collected at 3, 6, 12, and 24 months included all demographics, treatment parameters, and provider/patient-assessed cosmesis. RESULTS: The median follow-up period was 18.2 months (range, 0.2-53.4 months). The 30-day breast infection rate was 0.5 % of the patients (n = 4), and re-excision was performed for 8.1 % of the patients (n = 66), whereas 2.6 % of the patients (n = 21) underwent mastectomy. Two patients (0.2 %) had local recurrence. The patient-reported cosmetic outcomes at 6, 12, and 24 months were rated as good-to-excellent by 92.4 %, 90.6 %, and 87.3 % of the patients, respectively and similarly by the surgeons. The radiation oncologists reported planning of target volume (PTV) reduction for 46.2 % of the patients receiving radiation boost, with PTV reduction most commonly estimated at 30 %. CONCLUSIONS: This report describes the first large multicenter study of 818 patients implanted with the BioZorb® tissue marker during BCS. Radiation oncologists found that the device yielded reduced PTVs and that both the patients and the surgeons reported good-to-excellent long-term cosmetic outcomes, with low adverse effects. The BioZorb® 3D tissue marker is a safe adjunct to BCS and may add benefits for both surgeons and radiation oncologists.
BACKGROUND: Accurate identification of the tumor bed after breast-conserving surgery (BCS) ensures appropriate radiation to the tumor bed while minimizing normal tissue exposure. The BioZorb® three-dimensional (3D) bioabsorbable tissue marker provides a reliable target for radiation therapy (RT) planning and follow-up evaluation while serving as a scaffold to maintain breast contour. METHODS: After informed consent, 818 patients (826 breasts) implanted with the BioZorb® at 14 U.S. sites were enrolled in a national registry. All the patients were prospectively followed with the BioZorb® implant after BCS. The data collected at 3, 6, 12, and 24 months included all demographics, treatment parameters, and provider/patient-assessed cosmesis. RESULTS: The median follow-up period was 18.2 months (range, 0.2-53.4 months). The 30-day breast infection rate was 0.5 % of the patients (n = 4), and re-excision was performed for 8.1 % of the patients (n = 66), whereas 2.6 % of the patients (n = 21) underwent mastectomy. Two patients (0.2 %) had local recurrence. The patient-reported cosmetic outcomes at 6, 12, and 24 months were rated as good-to-excellent by 92.4 %, 90.6 %, and 87.3 % of the patients, respectively and similarly by the surgeons. The radiation oncologists reported planning of target volume (PTV) reduction for 46.2 % of the patients receiving radiation boost, with PTV reduction most commonly estimated at 30 %. CONCLUSIONS: This report describes the first large multicenter study of 818 patients implanted with the BioZorb® tissue marker during BCS. Radiation oncologists found that the device yielded reduced PTVs and that both the patients and the surgeons reported good-to-excellent long-term cosmetic outcomes, with low adverse effects. The BioZorb® 3D tissue marker is a safe adjunct to BCS and may add benefits for both surgeons and radiation oncologists.
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