A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Su
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ORIGINAL ARTICLE – BREAST ONCOLOGY
A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer Cary S. Kaufman, MD1,2, Michael J. Cross, MD3, Julie L. Barone, DO4, Nayana S. Dekhne, MD5, Kiran Devisetty, MD6, Joshua T. Dilworth, MD, PhD7, David A. Edmonson, MD8, Firas G. Eladoumikdachi, MD6, Jennifer S. Gass, MD9, William H. Hall III, MD10, Robert L. Hong, MD11, Robert R. Kuske, MD.12, Brandon J. Patton, MD4, Carol Perelson, RN13, Rogsbert F. Phillips, MD14, Arnold B. Smith, MD15, Linda A. Smith, MD16, Lorraine Tafra, MD17, and Gail S. Lebovic, MA, MD18 Department of Surgery, University of Washington, Seattle, WA; 2Bellingham Regional Breast Center, Bellingham, WA; Breast Treatment Associates, Fayetteville, AR; 4Saint Joseph Hospital, Denver, CO; 5Beaumont Hospitals, Southfield, MI; 6 Karmanos Cancer Institute, Detroit, MI; 7William Beaumont Hospital, Royal Oak, MI; 8Womens Oncology, Women and Infants Hospital, Providence, RI; 9Women and Infants Hospital, Breast Health Center, Providence, RI; 10Radiation Oncology, PeaceHealth St. Joseph Medical Center, Bellingham, WA; 11Virginia Hospital Center, Arlington Health System, Arlington, VA; 12Arizona Breast Cancer Specialists, Scottsdale, AZ; 13New York, NY; 14Metro Surgical Associates, Emory Healthcare, Atlanta, GA; 15Highlands Oncology Group, Fayetteville, AR; 16Comprehensive Breast Care, Albuquerque, NM; 17Anne Arundel Medical Center, The Breast Center, Annapolis, MD; 18School of Oncoplastic Surgery, Reno, NV 1
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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 BioZorbÒ 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 BioZorbÒ at 14 U.S. sites were enrolled in a national registry. All the patients were
Electronic supplementary material The online version of this article (https://doi.org/10.1245/s10434-020-09271-2) contains supplementary material, which is available to authorized users. Ó The Author(s) 2020 First Received: 24 July 2020 Accepted: 5 October 2020 C. S. Kaufman, MD e-mail: [email protected]
prospectively followed with the BioZorbÒ 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
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