Effect of BioZorb® surgical marker placement on post-operative radiation boost target volume

Wiens, Naomi; Torp, Lisa; Wolff, Brynn; Wert, Yijin; Barton, Katherine; Weksberg, David C.; Wilson-Dagar, Joella

doi:10.1007/s13566-017-0339-y

Cited by 14 publications

(18 citation statements)

References 8 publications

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“…This corresponds with previously reported study findings from a retrospective cohort study and a casecontrol study, both of which compared patients with and without BZ placement, and both reporting slightly more than a 30 % reduction in PTV or tumor bed volume for patients implanted with the BZ. 37,38 The ROs assessed the BZ as ''very useful'' for 86.6 % of the patients receiving APBI, with 85 % of the ROs reporting a 20 % to 30 % decrease in PTV for these patients. This may be expected given the necessity of precise targeting with APBI.…”

Section: Discussionmentioning

confidence: 99%

“…This marker has been associated with positive cosmetic and overall patient outcomes as well as reduced RT volumes in the few reported studies to date. [36][37][38][39][40][41][42] These studies have been small, focused on RT planning outcomes or limited to short-term follow-up evaluation. This is the first report of 24-month outcomes after BCS with BioZorb Ò (BZ) implantation in a large U.S. registry of data collected across an array of clinical settings.…”

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confidence: 99%

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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

et al. 2020

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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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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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

et al. 2020

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“…While pain and discomfort have been noted with the Biozorb device, without having a comparison with clips, it is difficult to fault the device versus the surgery performed (and possible subsequent radiation). It was notable that Wiens et al showed a statistically significant increase in the amount of radiation to the ipsilateral lung in the Biozorb arm compared to the traditional surgical clips arm but the long-term impact of this clinically is unknown (Wiens et al, 2018). Thus, clinical outcomes outside the cavity marking abilities of both interventions could not reliably occur given the scarce presence of peer reviewed, reasonable scientific data directly comparing each approach.…”

Section: Incremental Cost-utility Ratio (Icur) and Dominancementioning

confidence: 99%

“…A study performed by Ward et al exhibited Biozorb's presence on a variety of imaging modalities, including mammography, ultrasound, MRI, chest radiography, and CT in an effort to increase awareness over its form and appearance (Ward et al, 2018) A more recent study by Wiens at al. demonstrated the device's ability to reduce clinical target volume and planning target volume of boost radiation post-op with statistically significant results (Wiens et al, 2018). However, the authors noted no difference in the ability of the device to reduce radiation to secondary organs, an in fact noted an increase in ipsilateral lung radiation.…”

Section: Introductionmentioning

confidence: 97%

Cost-Effectiveness of the Biozorb Device for Radiation Planning in Oncoplastic Surgery

Rashad¹,

Huber²,

Chatterjee³

2018

CCO

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Purpose: With the extent of breast tissue manipulation using oncoplastic surgical techniques, there lies a challenge in marking the tumor bed for adjuvant radiation therapy planning. Two competing techniques in doing so exist and involve the traditional placement of surgical clips in the surgical tumor bed or the newer technique of placing a Biozorb marker in the tumor bed. Our goal was to perform a cost-utility assessment to see which tumor bed marking approach is more cost-effective. Based on device list prices and clinical outcomes from a comprehensive literature review, we assessed if an approach either dominated or had an incremental cost-utility ratio of less than $50,000/QALY since either would signify cost-effectiveness. Results: From a cost comparison, the Biozorb marker ($1250) was far costlier than the clip applier device ($50). Our PRISMA search (Figure 1) reviewed 133 articles for clip placement and 42 articles for Biozorb placement in oncoplastic surgery with 2 clip placement articles and 3 Biozorb articles meeting criteria. The available data for either marking technique suggests reasonable tumor bed identification for adjuvant radiation treatment without clear clinical advantages supporting one technique over the other. Overall clinical equivalence in the setting of a clear cost advantage suggests dominant cost-effectiveness in favor of clips. Conclusion: Using surgical clips to identify the tumor bed in oncoplastic surgery is dominant and more cost-effective over the Biozorb technique as clips are relatively inexpensive while both techniques reasonably identify the tumor bed.

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“…It allows for tissue ingrowth during the healing process and is slowly resorbed by the body over time. Current literature investigating the use of the BioZorb is limited and focused on its value in improving delivery of radiation . The impact of complications associated with placement of the BioZorb in patients who have had partial mastectomies has not been evaluated.…”

Section: Introductionmentioning

confidence: 99%

Utilization of BioZorb implantable device in breast‐conserving surgery

Srour

Chung

2019

Breast J

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BioZorb fiducial marker is an implantable device made of six clips to mark the surgical site of tissue removal in three dimensions. The marker facilitates focused radiation therapy, while allowing for tissue ingrowth during the healing process with resorption by the body overtime. Current literature investigating the use of the BioZorb is limited and focused on its value for radiation treatment. Our objective was to investigate the feasibility and surgical complications associated with the BioZorb in breast-conserving surgery. From April 2015 to June 2018, 89 patients who underwent 91 partial mastectomies with planned adjuvant radiation therapy and placement of the BioZorb.Demographics, type of BioZorb used, complication rate, and postoperative examinations were analyzed. A total of 89 patients who were a median age of 59 years (range 34-84) underwent 91 operations with BioZorb placement-86.8% underwent a partial mastectomy (n = 79), and 13.2% underwent a breast wide re-excision for margins at the time of BioZorb placement (n = 12). Of the 79 partial mastectomies, 21.5% (n = 17) were palpable tumors. Location of the tumor and subsequent BioZorb placement was most often in the upper outer quadrant (40.7%), followed by upper inner (27.5%), lower outer (20.9%), and lower inner quadrants (10.9%). 92.3% (n = 84) had a single BioZorb placed, 5.5% (n = 5) had two BioZorbs placed in a single lumpectomy cavity, and 2.2% (n = 2) had two BioZorbs placed in separate lumpectomy cavities of the same breast. Of the 10 different tissue marker sizes used, a 2 × 3 cm BioZorb was most commonly used (37/98, 37.8%), followed by 3 × 4 cm (25/98, 25.5%) and 1 × 3 × 2 (9/98, 9.2%). A total of five patients underwent immediate bilateral breast reduction following placement of the BioZorb. Of the 91 operations, 22 patients had a subsequent reoperation for positive margins after initial placement of the BioZorb, of which 86.4% retained the BioZorb. During these reoperations, only 1 patient had the BioZorb removed due to discomfort (4.5%) and two had it removed due to subsequent mastectomy (9.1%). At a median time of 1.1 years, the BioZorb continued to be palpable on clinical breast examination in 63.6% of patients. The longest time that the BioZorb continued to be palpable was 2.8 years. Additional imaging was ordered because a clinician palpated a mass, unaware it was the BioZorb 8.8% of the time 2 × 3 37/98 (37.8) 3 × 3 7/98 (7.1) 3 × 4 25/98 (25.5) 4 × 4 3/98 (3.1) 4 × 5 4/98 (4.1) Low-profile device sizes 1 × 3 × 2 9/98 (9.2) 1 × 3 × 3 3/98 (3.1) 2 × 1 × 1 1/98 (1.0) 2 × 2 × 1 4/98 (4.1) Abbreviation: cm, centimeters.

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Effect of BioZorb® surgical marker placement on post-operative radiation boost target volume

Cited by 14 publications

References 8 publications

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

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

Cost-Effectiveness of the Biozorb Device for Radiation Planning in Oncoplastic Surgery

Utilization of BioZorb implantable device in breast‐conserving surgery

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