Focused Treatment Means Better Outcomes

It’s designed to help surgeons communicate with radiation oncologists to accurately target where the tumor was during radiation treatment, but does it work, Dr. Cary Kaufman, FACS and Medical Director of the Bellingham Regional Breast Center, asked himself.

Of course, tests were released when BioZorb was approved by the FDA in 2012, proving safety and efficacy, but he wanted to find out for himself.

For about a year, he worked independently with 22 patients who all received breast lumpectomies to remove tumors. After the tumor was removed, he inserted the BioZorb in the pocket where the tumor was, and he evaluated what it meant for patients.

He found the device was easily recognizable on mammograms, ultra sounds and CT scans, which meant radiation oncologists could easily determine where the tumor was removed from, versus the tissue that was cut through to access to the tumor. He also noticed patients appreciated the cosmetic aspect of it that helps to prevent a sunken look of where the tumor was removed from.

In addition to these findings, Kaufman shared other observations.

SP: What did your experience using BioZorb include prior to this study?

Kaufman: My experience prior to using BioZorb was uninformed. I didn’t realize exactly where the patient would receive full dose therapeutic radiation. Previously I had placed clips to mark the site of the lumpectomy to demonstrate the target area to treat. Radiation oncologists are trained to treat not just the clips but also the seroma cavity. When I have dissected in areas that were only related to cosmesis such as tunneling or oncoplastic mobilization, seroma forms in these areas as well. These non-cancer associated sites of seroma were indistinguishable from the seroma associated with the cancer. The area targeted to treat was larger than the desired treatment site. This is associated with increase in dose volume and increase in radiation side effects.

SP: The first time you heard about this product, what was your reaction?

Kaufman: The first time I heard about it I didn't think I needed it for my patients since I routinely placed clips to mark the lumpectomy site. I didn’t realize that accurately targeting the lumpectomy margins at highest risk for microscopic tumor remaining is where they need to target the radiation. After using the BioZorb, I learned that I could improve targeting of the radiation -- directing it towards areas that need it, while avoiding areas that didn't require radiation. Even small decreases in the tissue area included in the treatment plan lead to large decreases in the PTV (planning target volume) markedly decreasing the amount of normal tissue that gets radiated. The marker helps this process by clearly identifying the target tissue area.

SP: The first time you used BioZorb, what was your experience like? Were there any unexpected challenges?

Kaufman: It was surprisingly easy to conceptualize and place. Technically it is placed at the exact location where the tumor previously resided. The surgeon who removes the tumor knows exactly where the tumor was located. Placing the BioZorb exactly at that site is quite clear. Thereafter, that exact location can be communicated to the radiation oncologist in a precise fashion. When I placed clips, I thought I was doing the same thing, but I didn’t realize that associated seromas may move clips, retraction with healing may distort relative clip orientation, and despite closing the dead space, regional seromas formed and were treated as the tumor bed.

SP: When you explained the procedure to the patients, was hearing about the cosmetic aspect appealing to them?

Kaufman: I was surprised how thankful patients would be when I mentioned that we were addressing the cosmetic effects of volume loss of the tumor with margins. They understood the concept quickly as I showed them a sample of the device. Some felt embarrassed to focus on issues other than cancer, but all were very open to using this device.

SP: Did you get feedback from the radiation team about how this product worked? If so, what were some of the things you heard from them?

Kaufman: Before the radiation team could respond, I needed to explain what we were doing and how it worked. Once they understood the concept, they were very appreciative to have a clear target to aid in their treatment plan. It is especially helpful for boost and partial breast irradiation. It also helped them with respiratory gating of treatment, since this target is so easily seen.

SP: I notice three patients required re-excision. Was this related to how the device was used? If so, what could be done in the future to ensure it doesn’t happen again?

Kaufman: The re-excision was not related to the BioZorb. A certain percentage of lumpectomy patients will have a positive margin, and require re-excision. In two of these patients, a single margin required re-excision which was performed. We re-excised the tissue and left the BioZorb in place. Treatment continued uninterrupted in those two patients. The third patient had multifocal positive margins, and the entire cavity including the BioZorb was re-excised. In that case, no BioZorb was replaced. Neither of these instances had anything to do with the BioZorb but was related to the nature of cancer growth.

SP: I see two patients had delayed cellulitis, which was resolved with antibiotics. Was this related to how the device was used? If so, what could be done in the future to ensure it doesn’t happen again?

Kaufman: Neither of these patients were related to the BioZorb. Both were patients who had uneventful surgery. After both of these patients started chemotherapy and their white count dropped to below satisfactory, they developed breast cellulitis/mastitis. Both were treated with holding chemotherapy until the white count returned to normal, antibiotics and aspiration. Neither had the BioZorb removed and both had full recovery without further incident, now many months post treatment.

SP: Any other comments?

Kaufman: Despite performing breast surgery for over 25 years, I never realized the need to improve the second layer of communication between the surgeon and the radiation oncologist. We must treat the target area, but the second layer is to avoid treatment of “bystander” breast tissue. That tissue which may be included as a target because there is nearby seroma, caused by tunneling or oncoplastic procedures. I believe I can better target what needs to be treated and avoid portions of the breast that do not need the targeted radiation and avoid some radiation side effects.