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

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.

Surgical excision of BioZorb device eroding through the nipple‐areolar complex one year postoperatively: A case report

“…There is currently a paucity of data related to the surgical complications secondary to use of a BioZorb. Reported complications seem to be minor and occur rarely 3,4 . However, our patient went on to complete post‐lumpectomy radiation for her DCIS, and nearly 9 months later presented with chronic symptoms of breast infection, pain, erythema, and ultimate erosion of the BioZorb through her skin 1 year after initial surgery.…”

“…Additionally, there is improved visualization of the lumpectomy cavity on imaging due to the titanium clips. Studies have also noted positive patient‐reported long‐term cosmetic outcomes related to use of the BioZorb 3 …”

“…Only a few studies have reported complications in the postoperative period for patients with a BioZorb. In one study using a multicenter registry, only 2.1% of patients had infectious complications and 2.7% underwent removal of the device 3 . Another single‐institution study from Chung and Srour concluded that the BioZorb was safe to use due to the rarity of complications.…”

Impact of the Delineation Accuracy of Lumpectomy Cavity on Planning Target Volume in Partial-Breast Irradiation Using Brachytherapy and External-Beam Radiotherapy

“…There are several methods to minimize uncertainties reported including the reference of preoperative CT, magnetic resonance imaging-based delineation, clip insertion, and tissue marker insertion. 16,37 However, no method has been established so far to achieve accurate cavity delineation.…”

Current Surgical Innovations in the Treatment of Breast Cancer

“…Some centers are using this for patients who are receiving radiation boost to the tumor bed. Cosmetic outcomes over two years are reported by Kaufman in his study of 818 patients (54) to be good to excellent in over 87% of patients with adverse effects in 3.8% of patients (n=31). Our experience largely confirms what is reported (unpublished).…”