Kaufman Cary S, Cross Michael J, Barone Julie L, Dekhne Nayana S, Devisetty Kiran, Dilworth Joshua T, Edmonson David A, Eladoumikdachi Firas G, Gass Jennifer S, Hall William H, Hong Robert L, Kuske Robert R, Patton Brandon J, Perelson Carol, Phillips Rogsbert F, Smith Arnold B, Smith Linda A, Tafra Lorraine, Lebovic Gail S
Department of Surgery, University of Washington, Seattle, WA, USA.
Bellingham Regional Breast Center, 2075 Barkley Blvd. Suite 250, Bellingham, WA, USA.
Ann Surg Oncol. 2021 May;28(5):2529-2542. doi: 10.1245/s10434-020-09271-2. Epub 2020 Nov 21.
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.
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.
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 %.
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.
保乳手术（BCS）后准确识别肿瘤床可确保在使正常组织暴露最小化的同时对肿瘤床进行适当放疗。BioZorb三维（3D）生物可吸收组织标记物为放射治疗（RT）计划和随访评估提供了可靠靶点，同时作为维持乳房外形的支架。
在获得知情同意后，美国14个地点植入BioZorb的818例患者（826侧乳房）被纳入一项全国性登记研究。所有患者在BCS后均对BioZorb植入物进行前瞻性随访。在3、6、12和24个月收集的数据包括所有人口统计学信息、治疗参数以及医生/患者评估的美容效果。
中位随访期为18.2个月（范围0.2 - 53.4个月）。30天乳房感染率为患者的0.5%（n = 4），8.1%的患者（n = 66）进行了再次切除，而2.6%的患者（n = 21）接受了乳房切除术。2例患者（0.2%）出现局部复发。患者报告的6、12和24个月美容效果分别有92.4%、90.6%和87.3%的患者评价为良好至优秀，外科医生的评价类似。放射肿瘤学家报告，46.2%接受强化放疗的患者的计划靶体积（PTV）减小，PTV减小最常见估计为30%。
本报告描述了首例对818例在BCS期间植入BioZorb组织标记物患者的大型多中心研究。放射肿瘤学家发现该装置使PTV减小，患者和外科医生均报告长期美容效果良好至优秀，且不良反应较少。BioZorb 3D组织标记物是BCS的一种安全辅助手段，可能对外科医生和放射肿瘤学家均有益处。
