Abstract
BackgroundAccurate 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.MethodsAfter 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.ResultsThe 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 %.ConclusionsThis 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.
Highlights
Accurate identification of the tumor bed after breast-conserving surgery (BCS) ensures appropriate radiation to the tumor bed while minimizing normal tissue exposure
CT computed tomography; NA not applicable for boost treatment planning; EPID electronic portal imaging device; CBCT cone-beam computed tomography; OBI on-board imaging aIn 3 cases with radiation oncologists survey responses, type of radiation therapy (RT) provided was not specified and is not included in the RT subgroup breakdown. In this first large-scale, multicenter study of patients implanted with the BZ during BCS, we report good oncologic outcome through the midterm follow-up visit and a low rate of reoperations or adverse effects (AEs) after BCS
We could not address whether oncologic outcome and recurrence rates are influenced by BZ usage. This is the first large multicenter study assessing outcomes for 818 patients implanted with a 3D bioabsorbable tissue marker during BCS with median follow-up period of 18.2 months
Summary
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. 818 patients (826 breasts) implanted with the BioZorbÒ at 14 U.S sites were enrolled in a national registry. Ó The Author(s) 2020 First Received: 24 July 2020 Accepted: 5 October 2020; Published Online: 21 November 2020
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